Tag Archives: pain

Operating on patients with complex regional pain syndrome

by Ryon Wiska DPM1*, Lawrence Fallat DPM FACFAS2

The Foot and Ankle Online Journal 11 (2): 3

Complex regional pain syndrome (CRPS) is a debilitating disorder characterized by widespread, chronic pain. While elective procedures should be held until acute CRPS flare ups have subsided, certain scenarios require immediate surgical care. Surgical management of patients with CRPS requires a team approach with several other specialties including pain management and anesthesiology.  In this article, we outline a pre-operative and post-operative management course for lower extremity surgery of patients with diagnosed CRPS. We also present several case reports where this protocol was utilized.

Keywords: Causalgia, Complex Regional Pain Syndrome, CRPS, Pain, Reflex Sympathetic Dystrophy, RSD, Surgical Management

ISSN 1941-6806
doi: 10.3827/faoj.2018.1102.0003

1 – Second year podiatric surgery resident at Beaumont Hospital, Wayne.
2 – Program director for podiatric surgery at Beaumont Hospital, Wayne.
* – Corresponding author: rwiska@gmail.com


Physicians have been documenting disorders of chronic pain for centuries, with earliest documentation spanning back to Ambroise Pare’s description of chronic pain with King Charles IX in the 17th century [1]. Mitchell and colleagues documented cases of chronic pain in soldiers secondary to gunshot wounds and injuries of peripheral nerves during the Civil War [2]. Complex regional pain syndrome (CRPS) has historically been known by multiple names including reflex sympathetic dystrophy, causalgia, Sudeck’s atrophy, and shoulder-hand syndrome. Most experts now abide by terminology introduced by the International Association for Study of Pain (IASP) in 1994, which subdivided CRPS into type 1 and type 2, with type 2 having an inciting nerve injury [3].

The diagnosis of CRPS is based on clinical findings. The original IASP diagnostic criteria for CRPS includes: 1) The presence of an initiating noxious event or a cause of immobilization. 2) Continuing pain, allodynia, or hyperalgesia with which the pain is disproportionate to any inciting event. 3) Evidence at some time of edema, changes in skin blood flow, or abnormal sudomotor activity in the region of pain. 4) This diagnosis is excluded by the existence of conditions that would otherwise account for the degree of pain and dysfunction [4]. More recent literature from the Reflex Sympathetic Dystrophy Association unveiled a clinical diagnostic criteria update, which reflects systemic findings that can be documented during patient visits (Table 1)[5]. Current management for active CRPS includes physical therapy, antidepressant agents, gabapentin, corticosteroids, topical analgesics, opioids, sympathetic blocks, somatic blocks, and neuromodulation [6-10].

  1. Continuing pain, which is disproportionate to any inciting event
  2. Must report at least one symptom in three of the four following categories Sensory: Reports of hyperalgesia and/or allodynia
    1. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
    2. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
    3. Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
  3. Must display at least one sign* at time of evaluation in two or more of the following categories
    1. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
    2. Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
    3. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin)
  4. There is no other diagnosis that better explains the signs and symptoms

* A sign is counted only if it is observed at time of diagnosis

Table 1 Clinical diagnostic criteria for complex regional pain syndrome.

In recent pain management literature, low dose naltrexone (LDN) has been shown to be efficacious in treating patients with CRPS [11].  LDN refers to doses approximately 50-fold lower than doses of naltrexone typically given to patients addicted to opioids [12]. It has been shown that LDN antagonizes the Toll-like receptor 4 (TLR 4) pathway and attenuate microglia. TLR 4 in both CNS neurons and microglia augments the production of pro-inflammatory cytokines via the nuclear factor kappa-light-chain-enhancer of activated B cells (NF- κB) pathway, which acts as a mediator for neuropathic pain [13]. In a double blind study of 30 women with chronic pain, twice daily administrations of 4.5 mg of Naltrexone resulted in 57% of the participants exhibiting a significant reduction in pain when compared to placebo [14].

The current paradigm of surgeons has been to avoid operating on patients with CRPS because symptoms could either recur or worsen. In 6-10% of patients, surgical intervention is warranted and should not be delayed. These conditions include painful deformity, displacement of fixation, fracture, trauma, tumors, and soft tissue masses [15].  Surgical management of patients with CRPS has been documented in orthopedic literature, with several papers discussing surgical intervention of the upper extremity and the knee [16,17]. Previous recommendations in the knee included waiting 5 months, with ranges from 2 months to 1 year. Prolonging surgery allows for subsidence of acute pain, as well as allowing time for treatment such as sympathetic blocks and physical therapy [16,17]. The purpose of this article is to outline a surgical management approach preoperatively and postoperatively for patients with active CRPS to provide the podiatric surgeon with management options, as well as review three cases in which this protocol was used.

Preoperative Management

Surgical management of patients with CRPS requires a team approach. It is imperative to coordinate with the physician who is actively managing the patient’s CRPS. If a patient does not have an active pain management specialist, consultation with a pain management specialist should be sought prior to operating. The surgeon should coordinate with the pain management physician as well as anesthesiologist regarding patient’s operative management course with clear understanding of preoperative and postoperative treatment.

Recent literature has found that low dose naltrexone (LDN) has been shown to be efficacious in treating patients with CRPS through its endorphin releasing and anti-inflammatory properties. However, it should be held at least 24-36 hours before surgery to ensure that opiate medication administered from anesthesia is able to reach full efficacy.

Anesthesia choice is critical in ensuring that CRPS flare-ups or increase in symptoms of active CRPS do not occur. Either epidural or spinal anesthesia should be utilized in patients with CRPS. This practice has been documented in orthopedic literature with studies showing recurrence rates of CRPS falling from 72% to 10% with the use of a preoperative spinal or epidural block [16]. It is believed that this may provide a clinical advantage by blocking the potential barrage of nociceptive afferent signals in the central nervous system during surgery [18].

When trying to evaluate whether epidural or spinal anesthesia should be performed, several variables should be considered such as time from start of induction to achievement of anesthesia, time for resolution of anesthesia, and possible side effects. In spinal anesthesia, the average time from intrathecal injection of local anesthetic to achievement of surgical anesthesia is 13 minutes in conventional spinal and 16 minutes in unilateral spinal [19]. In epidural anesthesia with insertion of catheter, the average time to achieve induction was noted to be 40 minutes [20]. When performing spinal anesthesia with 5 mg hypobaric bupivacaine, Ben-David reported two segment regression after 53 minutes and discharge after 180-190 minutes, with newer studies stating average PACU time following completion of procedure ranging between 65-98 minutes [21, 22]. Mulroy noted average PACU time for patients who received epidural prior to knee surgery as 92 ±18 minutes [23].

Epidural allows for the titration of short term local anesthetic which may lead to quicker discharge times following outpatient procedure, while still providing blockade to prevent CRPS flare-ups. In patients with CRPS, epidural catheter allows the option for continuous titration of anesthetic, which may be beneficial following the procedure, whereas spinal anesthesia employs a single dosage of anesthetic.

Common side effects noted in both spinal and epidural anesthesia are hypotension, bradycardia, post-dural puncture headaches, nausea, and vomiting.  In more severe side effects, prolonged neurological complications have been observed. In epidural anesthesia, urinary retention is also a common side effect, which may require catheterization and hospitalization.

Postoperative Management

Following the surgical procedure, patients are admitted for 24-48 hours of IV pain medication administration. Patients are given take-home oral analgesic medication for pain relief until acute surgical pain has subsided. Typical examples of oral medications include Percocet 10 mg/325 mg, 1-2 tablets by mouth every 4-6 hours, or Hydromorphone 2-4 mg, 1 tablet by mouth every 4-6 hours. If patients were previously taking LDN, they are to resume daily LDN when surgical pain is controlled and after 7 days have elapsed. We recommend early range of motion and aggressive physical therapy following procedure once the surgical site is stable. If symptoms of CRPS appear to be exacerbated following surgery, we recommend patients undergo intravenous Ketamine infusion therapy, under the management of their pain specialist.

Case Report No. 1

A 38-year-old male presented to our clinic one month after injuring his right foot when a 1000-pound roll of vinyl fell onto his foot. The patient was initially referred to our clinic for care of a nondisplaced fracture of the fifth metatarsal; however, radiographs and bone scan failed to reveal signs of fracture and a diagnosis of contusion to the right foot was made. The patient had been immobilized in a nonweightbearing below knee cast for one month and had subsequently developed increased pain out of proportion to injury as well as exhibited mottling of skin to dorsum of right foot in relation to left. The patient also began to exhibit rigid contractures of the right tibialis anterior, extensor digitorum longus, and extensor hallucis longus.  The patient was referred to a pain management specialist where the diagnosis of CRPS to the right lower extremity was made. The patient reported that since date of injury, the pain had progressively increased and at time of initial presentation, was so severe that even light touch to the right lower extremity was excruciatingly painful. On evaluation it was determined that the patient exhibited two distinct types of pain, a generalized CRPS pain to the affected lower extremity as well as a muscular pain secondary to rigid contractures. The patient was treated in our office monthly for peripheral nerve blocks at the level of the ankle joint consisting of 0.5% Marcaine plain, which the patient reported provided several hours of relief of contractures and pain before pain and contractures returned.  At the same time, he underwent 22 sympathetic blockades over the course of 3 years from 4 different pain clinics, but had no relief, despite multiple pain management treatment modality attempts including a spinal cord stimulator. The patient was treated noninvasively by pain management specialists as well as our clinic for approximately 3 years, at which time it was determined that pain level had plateaued and was not improving with the treatment.

The patient underwent three different manipulations of the right foot under epidural anesthesia. The extensor tendons were stretched for a period of 20 minutes, until relaxation of rigidly contracted muscles were noted. The patient was then placed in an anterior splint following the procedures. No acute flare up of CRPS was seen immediately after the procedure; however, the patient exhibited return of rigid contractures and pain 48 hours following each procedure and was unable to tolerate the anterior splint. No increase in CRPS pain was seen following procedures.

The patient then underwent a series of botox injections that provided some pain relief and reduction of contracture to right foot and ankle that lasted for approximately two to three weeks before the muscles returned to rigid clonus.

Surgical intervention to the right foot was discussed with the patient. The patient was offered procedures that included manipulation of the right foot under anesthesia, capsulotomy of the right first metatarsophalangeal joint, lengthening of the tibialis anterior, extensor hallucis longus, and extensor digitorum longus tendons, and sectioning of extensor hallucis brevis, all of the right foot. The patient was advised that procedure may exacerbate symptoms of CRPS and that no guarantees were given or implied. The patient met with his pain management specialist prior to the procedure and was given provisions for oral analgesics following the procedure.

On the day of the procedure, anesthesia was obtained with spinal anesthesia. The patient was placed on the operating table in the supine position. Manipulation of the foot was first performed where attention was made to manually plantarflex the right ankle joint as well as toes 1-5, which were noted to be rigidly contracted in a dorsiflexed position. Following manipulation, the foot was noted to held in a plantarflexed position. Standard z-lengthening procedures were then performed to the extensor digitorum longus, extensor hallucis longus, and tibialis anterior tendons. The extensor hallucis brevis tendon was identified and then sectioned proximal to its insertion.  Attention was then directed to the first metatarsophalangeal joint where a dorsal and lateral capsulotomy was then performed and contracture of the first metatarsophalangeal joint was noted to be decreased. Closure was completed using a combination of dissolving and nondissolving suture. A postoperative block was then infiltrated around the incision sites consisting of 9 mL of 0.5% Marcaine plain and 2 mL of dexamethasone.

Following the procedure, the patient was admitted for 48-hour pain management. The patient reported a relief in pain following the procedure and was able to tolerate weight bearing to the right lower extremity without the use of an assistive device for the first time since the injury. Ultimately, the patient reported return of CRPS pain and contractures 2 weeks following the procedure; however, no increase in CRPS pain was noted. In addition, the patient noted that contractures to the right lower extremity were not as rigid or painful.

Case Report No. 2

A 31-year-old female with history of CRPS type 1 after sustaining multiple injuries from a motor vehicle accident presented to our clinic with complaints of right ankle pain. The patient had history of multiple surgeries to her right ankle with internal fixation after suffering a comminuted open right ankle fracture. The patient’s pain was actively cared for by a pain management specialist who had maintained the patients pain in a tolerable level with the use of LDN as well as IV Ketamine infusion therapy. The patient presented to our office with complaints of a painful right ankle, which had subsequently developed a severe valgus alignment of the right heel, subtalar joint arthritis, a nonunion of a right fibular fracture, as well as pain along course of retained hardware. Despite active pain management therapy, the patient admitted to 10/10 pain to the right ankle.  The patient related that pain to her right ankle was becoming debilitating to the point that she was unable to ambulate. Initial attempts were made to treat the patient conservatively with the use of padding, bracing, and offloading with patient reporting no relief of pain. When conservative treatment options were exhausted, the patient was advised of surgical correction. The patient was made aware that surgical correction risked the possibility of a CRPS flare-up. She was fully aware of this and wished to proceed with procedure. Prior to boarding procedure, multiple conversations were had with patient’s pain management specialist as well as anesthesia team at our institution with preoperative, perioperative, and postoperative management discussed at length. It was determined that prior to procedure, patient was to hold LDN. The day of the procedure, patient was to obtain a popliteal block prior to induction and then undergo general anesthesia. The patient was then to be admitted for extended stay pain monitoring.

Twenty-four hours prior to procedure, patient’s LDN was held. On the day of the procedure, the patient was to undergo a popliteal block prior to induction; however, she did not receive the block prior to procedure. The patient was brought to the operating room and placed on the hospital table in the supine position where general anesthesia was obtained. The patient then underwent removal of painful retained bone screws and plates of the ankle, open reduction and internal fixation of right fibular nonunion, resection of synostosis of right ankle, excision of scar tissue of right ankle, medial transpositional calcaneal osteotomy with internal fixation of right foot, as well as arthrotomy of right ankle.  The patient was then placed in a well-padded cast and was instructed to be non-weight bearing to the right lower extremity with the use of crutches.

Following the procedure, the patient awoke from anesthesia in intense pain to the surgical limb. An epidural was placed and pain was controlled. The patient was converted to 48 hour full admit due to epidural. After 24 hours, she related that epidural was starting to wear off and was admitting to increased pain to surgical limb. The patient was maintained on IV Dilaudid and oral Percocet, 10 mg. After 4 days postoperatively, her pain was maintained on oral Percocet and patient was discharged home.  The patient went on to achieve surgical union of fibular fracture, but continued to admit to CRPS pain to the surgical limb, which limited activities of daily living. The patient related to no increase in CRPS pain. Six months following her procedure, the patient successfully underwent a spinal cord stimulator trial. Following insertion of the stimulator, the patient was able to stand and walk around a department store, which she had been unable to do following the initial accident. Although the patient still relates to CRPS pain, the pain related to her foot and ankle condition has subsided and no increase in CRPS pain has been noted.

Case Report No. 3

A 65-year-old female presented to our office with history of CRPS, which she developed following a third intermetatarsal space neurectomy to the left foot. On clinical exam, the patient exhibited symptoms of a neuroma to the second intermetatarsal space to the left foot as well as a stump neuroma to the third intermetatarsal space of the left foot and admitted to 10/10 left pain with maximal tenderness to the forefoot. The patient admitted that pain to the left foot was so intense that her ability to ambulate was becoming limited. Conservative treatment was attempted with offloading, padding, and local steroid injections to the affected intermetatarsal spaces, which provided little to no relief. Once conservative options had failed, surgical intervention was discussed with the patient.  The patient was advised that the proposed procedures would be an excision of neuroma to second and third intermetatarsal space of the left foot. The patient was made aware that CRPS symptoms could be exacerbated by the procedure and that clear pain management goals were outlined with her pain management physician.

On the day of the surgery, anesthesia was obtained with spinal anesthesia as well as a local anesthetic block to the second and third intermetatarsal spaces of the left foot. Anatomic dissection was carried down to the level of the neuroma and nerve was tracked proximally until healthy nerve tissue was observed. Inflamed nerve was then resected from the second and third intermetatarsal space. A 4 cm x 2 cm x 0.5 cm nerve specimen was excised from the second intermetatarsal space and a 2 cm x 1.5 cm x 0.3 cm nerve specimen was excised from the third interspace.  Closure was then performed with a combination of dissolving and non-dissolving suture and a postoperative block was infiltrated to the incision site consisting of 9 mL of 0.5% Marcaine plain and 4 mL of dexamethasone. The patient was given Norco 7.5 mg/325 mg for pain control postoperatively and was partial weight bearing to the left heel in a surgical shoe. The patient declined postoperative observation for pain management and was discharged home once cleared by anesthesia.

Following the procedure, the patient reported no increased exacerbation of CRPS and admitted to decreased pain to the neuroma site on the left foot. While the patient still reports CRPS pain to the left lower extremity, she is now able to pursue activities of daily living and maintains a tolerable level of pain to the left lower extremity.

In conclusion, our outlined pre-operative and post-operative management course for lower extremity surgery of patients with diagnosed CRPS has proven effective in preventing flare-ups of CRPS and preventing increase of active CRPS pain.

Funding Declarations

No funding was used.

Conflict of Interest

None

References

  1. Pare A. Of the cure of wounds of the nervous parts. In The Collected Works of Ambroise Pare, book 10, pp 400-402, translated by T Johnson, Milford House, Pound Ridge, NY, 1634.
  2. Mitchell SW; Morehouse GR,  Kenn WW. Gunshot Wounds and Other Injuries of Nerves, pp 148-157, JB Lippincott, Philadelphia, 1864.
  3. Stanton-Hicks M, Baron R, Boss R, et al. Complex regional pain syndrome: guidelines for therapy. Clin J Pain. 1998; 14:155-166.
  4. Merskey H, Bogduk N. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms, 2nd edition. Seattle, WA: IASP Press; 1994.
  5. Harden, R. N., Oaklander, A. L., Burton, A. W., Perez, R. S. G. M., Richardson, K., Swan, M., Barthel, J., Costa, B., Graciosa, J. R. and Bruehl, S. (2013), Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 4th Edition. Pain Med, 14: 180–229. doi:10.1111/pme.12033
  6. Rho RH, Brewer RP, Lamar TJ, Wilson PR. Complex regional pain syndrome. Mayo Found Med Educ Res 77: 174-180, 2002.
  7. Oerlemans HM, Oostendorp RA, de Boo T, van der Laan L, Severens JL, Goris JA. Adjuvant physical therapy versus occupational therapy in patients with reflex sympathetic dystrophy/complex regional pain syndrome type I. Arch Phys Med Rehabil. 2000; 81:49-56.
  8. Kingery WS. A critical review of neuropathic pain: antidepressants and opioids. Clin J Pain. 2000; 16 (2, suppl):S49-S55.
  9. Kemler MA, Barends GAM, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000; 343:618-624.
  10. Van Hilten BJ, van de Beek W-JT, Hoff JI, Voormolen JHC, Delhaas EM. Intrathecal baclofen for the treatment of dystonia in patients with reflex sympathetic dystrophy. N Engl J Med. 2000; 343: 625-630.
  11. Chopra P, Cooper M. Treatment of complex regional pain syndrome using low dose naltrexone. J neuroimmune pharmacol. 2013; 8:470-476.
  12. Rea F, Bell JR, Young MR, Mattick RP. A randomized controlled trial of low dose naltrexone for the treatment of opioid dependence. Drug Alcohol Depend. 2004; 75:79-88.
  13. Milligan ED, Watkins LR. Pathological and protective roles of glia in chronic pain. Nat Rev Neurosci. 2009; 10:23-26.
  14. Younger J, Noor N, McCue R, Mackey S (2013) Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum, 2013; 65(2):529–538
  15. Moesker A: Complex regional pain syndrome, formerly called Reflex sympathetic dystrophy, treated with Ketanserin and Carnitine (thesis). Rotterdam, Erasmus University Rotterdam, 2000, pp 1-147.
  16. Reuben S, Rosenthal E, Steinberg R. Surgery of the affected upper extremity of patients with a history of complex regional pain syndrome: a retrospective study of 100 patients. J of Hand Surgery. 2000; 6:147-151.
  17. Katz MM, Hungerford DS:  Reflex Sympathetic Dystrophy Affecting the knee.  J Bone Joint Surg. 1987; 69: 797 – 803.
  18. R. Norman Harden, MD, Stephen Bruehl, PhD, Michael Stanton-Hicks, MB, BS, DMSc, FRCA, ABPM, Peter R. Wilson, MB, BS; Proposed New Diagnostic Criteria for Complex Regional Pain Syndrome. Pain Med 2007; 8 (4): 326-331.
  19. Fanelli, G, Borghi, B, Casati A, et al. Unilateral bupivacaine spinal anesthesia for outpatient knee arthroscopy. Can J Anesth 2000; 47 (8):746-751.
  20. Koenig T, Neumann C, Ocker T, Kramer S, et al. Estimating the time needed for induction of anesthesia and its importance in balancing anaesthetists’ and surgeons’ waiting times around the start of surgery. Anaesthesia 2011; 66:556-562.
  21. Ben-David B, Levin H, Solomon E, Admoni H, Vaida S. Spinal bupivacaine in ambulatory surgery: the effect of saline dilution. Anesth Analg 1996; 83: 716–20.
  22. Valanne J, Korhonen AM, Jokela R, Ravaska P. Selective spinal anesthesia: A comparison of hyperbaric bupivacaine 4 mg versus 6 mg for outpatient knee arthroscopy. Anesth Analg 2001; 93: 1377-9.
  23. Mulroy M, Larkin K, Hodgson P, et al. A comparison of spinal, epidural, and general anesthesia for outpatient knee arthroscopy. Anesth Analg 2000; 91:860-4.

Distant Intentionality Healing And Its Effects On Post-Operative Pain And Narcotic Usage After Foot And Ankle Surgery

by Gerald T. Kuwada, DPM, NMDpdflrg

The Foot and Ankle Online Journal 6 (9): 1

A double blind, randomized study using Distant Intentionality Healing (DIH) and narcotic analgesic use was completed. The author wanted to determine if there was any difference between the control group and the group receiving DIH on the total number of narcotic analgesics taken after foot and ankle surgery for 3 weeks post-op. The study found that there was on average 7 less narcotic analgesics taken by the DIH group than the control group. The study reveals this is a significant difference between the control group and the group receiving the DIH at p.01 level.

Key words: Pain, Narcotics

Accepted: August, 2013
Published: September, 2013

ISSN 1941-6806
doi: 10.3827/faoj.2013.0609.001


Address correspondence to: Gerald T. Kuwada, DPM, NMD, 13701 SE 201, Kent, WA 98042. drgeraldkuwada@hotmail.com


The author defines DIH as the intent to benefit another human being, living organism and human event. DIH studies number over 2000 since its initial research conducted in the early 1960s. One of the pioneers in this controversial research was Dr. Grad who used animal and plant studies as subjects and paved the way for eventual human studies once DIH was demonstrated to be safe, with no toxic or ill side effects and safe to plants and animals.[1-3] HIV-AIDS patients, post myocardial infarct patients, post-op pain, post-op complications were shown to also respond positively to DIH in a significant manner.[4-8]

The question about how DIH works on living organisms including human beings remains a mystery. Several authors have suggested that the answer lies within quantum physics and the concept of non-locality and entanglement theory.[9-11] The anatomic location of the mind and consciousness have proven to be just as mysterious as physicians and scientists have yet to locate where the mind is located anatomically.[12] Physicists use the term non-locality because the mind and consciousness are not located in a specific anatomic location. Earlier speculations and assumptions were the mind was located in the brain. Brain mapping studies have not corroborated this assumption.[13] Neuroanatomists have correlated anatomic sites with function of the brain.

The use of functional MRI(fMRI) has been used to see if DIH increases blood accumulation in various locations in the brain following meditation.[14] Certain experienced meditators have permanently changed their brain function compared to new meditators.[15]

The author proposes to use fMRI to study the effects of DIH on brain functioning and the immune system in the future.

Another aspect of this study will determine if there is significant post-op pain rating reduction between the control group and the DIH group during the 3 weeks post-op. This would be correlated with narcotic analgesic usage and may demonstrate that reduction in post-op pain should reduce pain medication use.

Methods

Initially there were 52 patients in this study over a 3 year period. The surgical patients who participated signed consent forms to participate in this study. These patients were randomly selected for the control group and the DIH group. They were not informed which group they were selected for. They were all given 40 pain pills ranging from Demerol, Vicodin, and Percocet. Most of the patients were prescribed Percocet. At the end of the 3 week period they returned to the clinic and the number of narcotic analgesics were counted and recorded by the research assistant. The first week pain rating and the 3rd week pain rating were also recorded for every patient in this study. The surgeon had no idea who participated in this study and which groups they were assigned. For 2 minutes twice daily once in the morning at 5 a.m. and the evening at midnight the author-healer sent the intention of less pain and less pain medication usage to the DIH group. The rest of the time the healer visualized encircling the DIH group in healing light and energy.

Results

The null hypothesis in this study is that there will be no difference between the control group and the DIH group regarding subjective post-op pain rating and pain pill use. The null hypothesis was rejected as there was significant difference between the control group and the DIH group at the p .01 level using a 2 tailed z score test. The mean score for the control group is 38.4 pills taken per patient. The mean score for the DIH patients is 31.9 during the 3 week post-op period. The mean pain reduction score for the control group is 3.3/10 with 0 equal to no pain and 10 equal to the most severe pain. The DIH group mean pain reduction is 3.96. This is calculated by subtracting the 1st week subjective pain score from the 3rd week subjective pain score. The control group mean subjective pain rating was 5.54/10 for the first week whereas the DIH mean subjective pain rating is 6/10. The mean pain rating score at the end of 3 weeks is 2.23/10 for the control group and 2.03/10 for the DIH group. There were 11/25 or 44% patients in the control group who had a pain rating of 0/10 at the end the 3 week post-op period. There were 33% or 8/24 for the DIH group who had 0/10 pain rating at the end of the 3 week post-op period. There was one patient in the control group who had a subjective pain rating for all 3 weeks of 10/10. The control group patients took a total of 960 narcotic analgesics during the 3 week post-op period. The DIH group took a total of 767 narcotic analgesics over the same period. This is 193 less pain pills taken by the DIH group which correlates positively with the groups lower mean pain rating at the end of the 3 weeks contrasted to the control group. The surgeries ranged from digital procedures, simple to complex bunionectomies, midfoot procedures, rearfoot and ankle procedures.

Discussion

This study reveals that the DIH group took less pain medication and had less pain post-op following foot and ankle surgery. Three patients were removed from the study due to injuries suffered during the 3 week post-op period. All 3 patients skewed the data and were removed from the study as they required more pain medication. Two patients were from the DIH group and one was from the control group. For example the patient from the control group took a total of 130 pain pills during the 3 week post-op period. Whereas the 2 from the DIH group totally took 170 pain pills. Two patients had triple arthrodesis performed and were prescribed Demerol for the 3 week post-op period. Most of the patients were prescribed either Vicodin or Percocet. There is a positive correlation between less subjective pain experienced and using less pain medication which one would suspect would occur. Conversely, having more post-op pain correlates to using more pain pills which is predictable. The DIH group had a higher first week subjective pain rating mean score than the control group. However, by the end of the 3 week post-op period the DIH group had less subjective pain mean score than the control group.

Though the difference between the control group mean of 38.4 narcotics taken and the 31.9 mean for the DIH group doesn’t seem large, yet, when extrapolated over many patients who have had surgery, the number has economic impact on patients, insurance companies and our health care system. According to the World Health Organization (WHO) the USA ranks 38th in the world for health care.16 It is also regarded as the most expensive health system in the world. Perhaps using DIH and other economic and beneficial treatment regimens will help to improve our use of our wealth in a more productive manner and distribute health care to more Americans who are currently locked out of our health care system.

For example, if 50000 patients in the state of Washington had foot and ankle surgery in 2012 and each patient was prescribed 40 tablets of a narcotic analgesic, for the control group whose mean use was 38.4 pills per 3 week post-op course this would translate to 1,920,000 pills for 50000 patients. For the DIH group with a mean use of narcotics being 31.95 per patient, this would translate into 1,597,000 pills. The DIH patients would have taken 322,500 less narcotic analgesics during the 3 week post-op period. If 40 tablets of the narcotics retail costs 38 dollars this translates to a total savings of 306,375 dollars for DIH patients who had foot and ankle surgery. If you add all the surgical patients from all the surgical disciplines in the USA in a single year, and assume that DIH would affect these surgical patients similarly as the patients who had foot and ankle surgery, the savings would be in the billions of dollars. There would also be an additional benefit of avoiding or decreasing complications and side effects of taking narcotic analgesic usage due to DIH use.

How DIH causes the affect based on the healer’s intention remains a mystery at this time. Previous functional MRI (fMRI) studies on DIH patients have shown that there appears to be specific areas of the brain that are stimulated during DIH healing sessions. The recipient’s precuneus, anterior cingulated, middle cingulated gyrus and frontal lobes are stimulated during the DIH healing sessions by increased blood flow. The precuneus functions in a wide spectrum of highly integrated tasks including visiospatial imagery, episodic memory retrieval and self processing operations like first person perspective. The anterior cingulated gyrus also has multiple complex functioning including self awareness of errors being committed and reaction to this awareness. Risk predictions, cognitive control, emotion regulation, conflict monitoring adjustments in behavior, minimizing distractions are also some of the functions. Other functions include but not limited to problem solving, concentration on tasks, information transfer form auditory stimuli to the cortices for processing, empathy from pain and cravings. The middle cingulated gyrus functions primarily in the regulation of the hypothalamic-pituitary-adrenal responses primarily to stress.

Frontal lobe functioning involves reasoning, planning and problem solving, speech recognition, movement and emotions. The healer’s parahippocampal gyrus is activated during the healing session. The parahippocampal gyrus functions in memory retrieval, creation of memory and communication and visual cues. It appears that DIH affects the brain in complex ways in order to respond positively to the intentions of the healer. The author proposes to use fMRI to further investigate what goes on in the brain during the DIH in the healer’s brain and the target patient’s brain during the healing session. Based on other studies using fMRI, experienced meditators had areas of the brain that were permanently affected compared to beginning meditators. This is consistent with other physiologic effects of experienced versus beginning meditators. The experienced meditators typically had lower physiologic effects such as pulse, respiration, galvanic skin response, brain wave activity and more.

Conclusion

DIH significantly reduced the number of narcotic analgesics taken during the 3 week post-op period after foot and ankle surgery. The DIH patients also had less pain contrasted to the control group. Logically this is what you would expect that if you have less pain a patient will take less pain medication as demonstrated in this study. Lastly there were no complications or reported side effects of DIH use in the DIH patient population during the 3 week post-op period.

References

1. Grad, B. The Biological Effects of the Laying on Hands on Animals and Plants: Implications for Biology: Parapsychology: Its Relation to Physics, Biology, Psychiatry. Ed. G. Schmeidler. 1967. Scarecrow Press, N. J.
2. Grad, B. A Telekinetic Effect on Plant Growth, Part 2: Experiments Involving Treatment of Saline in Stopper Bottles. International Journal of Parapsychology, 1964, vol. 6: 473-498.
3. Grad, B. Healing by Laying on of Hands: A Review of Experiments in Ways of Health: Holistic Approaches to Ancient and Contemporary Medicine. Ed. D. Sobel. 1979 Harcourt Brace, NY.
4. Sicher, F., Targ, E., Moore, D., Smith, HS. A randomized double blind study on the effect of distant healing in a population with advanced AIDS-report of a small scale study. Western Journal of Medicine. 1998. 1696): 356-363.
5. Harris, W., Gowda, M., Kolb, KW, Stychacz, CP, Vacek, JL, et al. A randomized controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Archives of Internal Medicine. 1999. 159(19):2273-2278.
6. Kuwada, GT., Distant Intentionality Healing for reduction of post-operative pain following foot and ankle surgery. A randomized, double blind study. Submitted to the Journal of Alternative and Complementary Med. 2006.
7. Kuwada, GT., Distant Intentionality Healing ( DIH): A randomized double blind study on post-operative care and cost to care for complications following foot and ankle surgery. 2012 Foot and Ankle Online Journal 5 (1): 1-10.
8. Jonas, W., Crawford, C. (eds.) Healing: Intention and Energy Medicine: Science, Research Methods and Clinical Implications. 2003. London: Harcourt.
9. Einstein, A., Podolsky, B., Rosen, N. Can Quantum Mechanical description of physical reality be complete? Phys. Rev. 19355:47:777-780.
10. Pizzi, R., Rantasia, A., Gleain, F. et al. Non-local correlation between human neural networks. In: Donkar, E., Pirick, AR, Brandt, HE. Eds. Quantum Information and Computation II. Proceedings of SPIE 5436:2004: 107-117.
11. Standish, L., Johnson, J., Clark, L., Todd, R., Kozak, L. Evidence of correlated fMRI signals between distant human brains. Alt. Therapies in Health. 2003. 9:122-128.
12. Lazar, S., Bush, G., Gollub, RL, Ricchione, GL., Khalsa, G., et al. Autonomic Nervous System: Functional Brain mapping of the relaxation response and meditation. Lippincott Williams and Wilkins, Inc. 2000.
13. Achterberg, J., Richards, T., Salomie, IA., Cooke, K. Individual Recipients’ functional brain changes during distant intentionality. A fMRI Analysis. Presented at the North American Research Conference on Complementary and Integrative Medicine, May, 2006.
14. Davidson, RJ., Kabat-Zinn, J. et al. Alterations in brain and immune function produced by mindfulness meditation. Psychosomatic Medicine. 65(4):564-570. 2003.
15. Shealy, C., Smith, N., Liss, T., Borgmeyer, S. EEG Alterations during Healing. Subtle Energies. 2000:11(3):241-248
16. World Health Organization. World Health Organization Report 2000. Geneva, Switzerland. WHO: 2000.

Transdermal Continuous Oxygen Therapy as an Adjunct for Treatment of Recalcitrant and Painful Wounds

by Danae Lowell, DPM, DABPS1 , Bonnie Nicklas, DPM, DABPS2 , William Weily, DPM3 ,
Felicia Johnson, DPM4 , Michael C. Lyons II, DPM5

The Foot and Ankle Online Journal 2 (9): 4

Oxygen has an undisputed role in wound healing. On a cellular level, oxygen impacts collagen production and development through its effects on enzymes. As such, oxygen is critically important for angiogenesis, the production of granulation tissue, as well as resistance to infection. Adequate delivery of oxygen to the wound tissue is vital for optimal healing. Historically, there have been multiple vehicles utilized to deliver oxygen in order to enhance healing. Two examples include hyperbaric oxygen and non-hyperbaric oxygen filled polyethylene or plastic bags. Both are used intermittently. Additionally, systemic delivery by nasal cannula has been utilized which can be monitored by digital pulseoximetry. Transcutaneous oxygen has been injected topically to enhance ligament healing as well as topically for surface wound healing. A new technology: Transdermal Continuous Oxygen Therapy (TCOT) is another delivery system which provides a flow of continuous pure oxygen directly to the wound bed. The authors present a series of 4 case presentations where this new technology was utilized to treat severe wounds in 4 separate patients. All wounds had been recalcitrant to multiple treatment modalities and each had a significant component of pain. The results were satisfactory in that all wounds healed completely, with the additional benefit of complete reduction in pain.

Key Words: Oxygen, pain, Transdermal Continuous Oxygen Therapy, hyperbaric, EPIFLO.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License.  It permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ©The Foot and Ankle Online Journal (www.faoj.org)

Accepted: August, 2009
Published: September, 2009

ISSN 1941-6806
doi: 10.3827/faoj.2009.0209.0004


In 1775, Joseph Priestley a British physician made medical history with the discovery of oxygen, although, it was Lovoisier, who gave the “oxygen” to the gas discovered by Priestley. Priestley’s landmark finding suggested that oxygen was necessary to sustain human life. [1]

The origin of hyperbaric medicine is firmly rooted with the advent of underwater diving. Though the exact date is not known, amazingly there is evidence dating back as far as 4500 B.C. [2,3]

More recently, some notable inventors that influenced extending time underwater include DiVinci, with the first sketches of an air tight diving chamber, the Dutch inventor Drebbel who created the first true diving bell in 1620, and Halley in 1691, who discovered a way to replenish the air supply while being under water. The first recorded use of a hyperbaric chamber used for medical therapy is credited to a British physician/clergyman, Henshaw in 1662. [2,3,4]

Henshaw devised a way using large bellows to either increase air pressure in the chamber to treat acute diseases or decrease pressure to treat chronic ones. The nineteenth century saw an explosion in the use of hyperbaric chambers for medical aliments of the day. From the “in Vogue” use in compression therapy spas in the 1850’s to French surgeon Fountaine’s development in 1879 of the first mobile hyperbaric operating room. This was reported to decrease side effects of anesthesia. [2,3] The first reported use of hyperbaric chamber in North America was by a Canadian named Henshaw in 1860. Hyperbaric technology has been used extensively in military medicine over the past two centuries and is becoming more common in clinical practice. This increase in clinical medicine is due to fairly recent advancements in hyperbaric medicine and recognition and certifications by Hyperbaric Medical Society. [5] Ultimately, the use of the hyperbaric oxygen chamber can be implemented in many forms, staring with the traditional model of huge and complicated walk-in chambers to the use of small plastic or metal chambers. [6,7] Notwithstanding the many positive effects that oxygen can have on wound care, providing oxygen to open wounds can be very complicated and expensive, in terms of money and time.

Today, there are several methods by which oxygen is provided to patients in the clinic setting. One method employs the use of inhalation therapy to provide an enriched oxygen supply via nasal cannula, or ventral mask. Oxygen administration provided in this fashion can be used to improve tissue oxygen concentration which is vital for optimal healing and resistance to infection. Measurement of PaO2 can be accomplished introducing a small oxygen sensor in the tissue. Subcutaneous tissue is the first tissue to suffer from oxygen deprivation and the last to be normalized. As a result, this tissue level is the optimal place for monitoring general tissue perfusion. [7] The measurement of blood saturation (pulse oximetry) is used routinely in clinical setting. This method however, primarily reflects oxygen conditions in the blood, and it only has value in situations where all factors that influence PaO2 are functioning optimally. [8]

To normalize this value to non-surgical level after major surgical procedures, the patients must be given supplementary oxygen.9 Inhalation therapy is easy, cost effective, and a useful way to provide supplementary systemic oxygen which has been shown to decrease the infection rate after certain types of surgery. [8]

Another method of providing oxygen systemically is by way of hyperbaric technology. The use in wound healing is based on the enhanced solubility of oxygen in blood and body fluids under hyperbaric conditions. [10] In hyperbaric oxygen chambers, a patient breathing oxygen at 2 to 3 atmospheres of pressure may carry as much as 5 to 6mL dissolved oxygen per 100ml of blood. [11] This enhances oxygen delivery to hypoxic tissues. However, with most cases, the oxygen content in the blood is not the issue because blood has more than adequate supplies for wound healing as long as the tissues themselves are adequately vascularized. With systemic therapy, the oxygen is delivered via the dermal capillaries to the vicinity of the ulcer, and thereafter by diffusion through granulation tissue. With inadequate blood supply to ischemic tissue at the base of the ulcer, the benefit is questionable, although the increased flux from the distally distributed capillaries may increase concentration of the diffusionally deliver oxygen at the ulcer site. Additional work is needed to determine its full value and efficacy.

For skin ulcers, it has been reported that the superficiality of the wounds makes them particularly amenable to topical administration of hyperbaric oxygen. [12] However, hyperbaric oxygen has inherent tendencies to produce vasoconstriction, toxicity, and tissue destruction. Even in topical therapy with oxygen administered at pressures as low as 1.04 atmospheres, it is necessary to tread the thin line between the beneficial effects of neovascularization and the damaging effects of toxicity with destruction of the newly formed blood vessels. [13] This concern has lead some investigators toward utilization of topically applied oxygen, referred to as “topical hyperbaric oxygen (THO) therapy“, or even more erroneously “hyperbaric oxygen therapy“.

The advocates of this topical oxygen administration claim several advantages over systemic hyperbaric oxygen, including decreased cost, increased safety, decreased complications and putative physiologic effects including decreased free radical formation and more efficient delivery of oxygen to the wound surface. [14] Specifically, oxygen is delivered directly to the skin via plastic or polyethylene bags surrounding the area of interest and secured by a constrictive device to achieve an airtight seal. Variable success has been reported, [15 – 23] many of these results have been anecdotal. The validity of many of these reported outcomes has been examined and often refuted based on a variety of parameters. [14] Additionally, others have reported that healing of diabetic foot ulcers was not accelerated by THO therapy. [24] In summary, the use of topical oxygen to enhance wound healing is in and of itself nothing new, in fact published reports of topical oxygen date back to the 1960’s. [25]

Topical application of oxygen in a focused manner, directed at the site of interest has been studied by way of transcutaneous topical injection and surface application. Specifically, transcutaneous topical injection of oxygen has demonstrated improved healing in ligaments in laboratory rats. [26] Focused transdermal oxygen under a Tegaderm® patch has been applied in the research setting by Fries and others, evaluating healing in surgically placed wounds on the backs of laboratory pigs. [27] The treatment was used for 3 hours daily for the first 7 days following injury. Real-time wound-bed PaO2 measurements were performed non-invasively. Biopsy of the wound bed by dual fluorescence staining of the tissue sections showed that the edge of oxygen treated wounds had a higher density of blood vessels than that in the edge of the room air exposed control wounds. [27] In a recent study of topical oxygen, Gordillo et al., [28] conducted a non-randomized enrollment of patients into Hyperbaric (HBOT, n=32) and topical oxygen (TO, n =25) treatments. Under the conditions of the study, HBOT seemed to benefit some wounds while not benefiting others. However, TO will significantly improved wound size. The authors conclude that TO treatment benefits wound healing in patients suffering from chronic wounds.

A new devise for Transdermal Continuous Oxygen Therapy (TCOT) is the EPIFLO® delivery system. This portable generator delivers 3 milliliters of pure oxygen per hour with ambient humidity, 24 hours per day, 7 days per week directly to the wound bed, through a sterile 43″ long 5fr. cannula and is covered with an occlusive dressing. Developed by Ogenix Corporation, this device weighs only a few ounces. This provides a moist wound environment which is continuously bathed in pure oxygen. At the cellular level, oxygen is metabolized, stimulating an increase in growth factors including, epithelialization, granulation tissue, glycosaminoglycan production, and collagen synthesis. A study by Said and others demonstrated its efficacy using a well-established rabbit ear model for acute wound healing. [29] The resulting histological analysis of the wounds showed significantly greater healing at both day 5 and day 8 in response to oxygen therapy. [28] Additionally, epithelial wound coverage was almost doubled in treated ear wounds when compared with controls. The authors concluded that epithelial wound healing was improved by the use of transdermal sustained-delivery treatment with 100% oxygen. Most recently, three spinal cord injury patients receiving TCOT showed positive results after short term use of the EPIFLO® system. [30] The authors used this delivery system, for the treatment of complex lower extremity wounds in the following case reports.

Case 1

In August of 2002, a 56 year-old Caucasian male presented to the Louis Stokes VA Medical Center complaining of a non-healing painful ulcer on his right ankle since March when he injured himself with an axe while chopping wood. (Fig. 1) The patient’s past medical history (PMH) was significant for CAD with an EF of 60%, hyperlipidemia, hypothyroidism, HTN, PVD, history of DVT, (definitions required?) and venous insufficiency. Surgical history includes fem-fem bypass surgery in 1999. Social history includes an 85+ pack-years of smoking. Patient had been receiving no formal wound care, but performed dressing changes on his own consisting of hydrogen peroxide for cleaning and chloraseptic spray for pain relief as well as a light dry sterile cover.

Figure 1  Case #1, the right medial ankle at initiation of EPIFLO® therapy on November 19, 2004.

The patient had recurrent infections of the ulcer requiring multiple courses of antibiotics. Physical exam reveals palpable dorsalis pedis and posterior tibial pulses. Uniformly warm temperature noted and capillary fill intact to digits. Diffuse varicosities were noted bilaterally. The painful right ankle ulceration measured approximately 3×3 cm with a mixed fibro-granular base and non-necrotic edges. No hyperkeratosis, tracking, probing, undermining, odor, or fluctuance noted. Multiple conventional wound care modalities were initiated including compression therapy with no resolution noted. Pain in the area remained constant. Despite meticulous wound care and appropriate consultations, the wound slowly increased in size until it 9.8 cm x 6.5 cm x 1 cm depth and was a 50/50 mix of fibrotic and granular tissue. Patient had a visual analog pain scale score of 6 – 10/10.

TCOT was initiated with the following regimen of Kaltostat® to the wound bed, hydrocolloid dressing to periphery, and EPIFLO® unit to the wound bed under occlusion with Tegaderm. Upon follow up the wound was described as less painful. Pain score on visual analog was noted to be 2/10.

TCOT regimen consisting of weekly replacement remained in place with continued healing as evidenced by a decrease in wound size to 2.0 cm x 1.5 cm. (Fig. 2)

Figure 2 Case #1, the right medial ankle at completion of EPIFLO® therapy on June 10, 2005.

Case 2

In early August of 2004, a 64 year-old Caucasian male presented to the Louis Stokes VA Medical Center complaining of a painful ulcer on his left lateral calf which had been present off and on over the last 35 years. (Fig. 3) Most recently the ulceration had opened 2 months ago. Patient’s PMH significant for history of DVT, Hepatitis C, PVD, HTN, GERD, venous insufficiency. Medications include percocet, ASA, warfarin, atenolol, metformin, mirtazapine, and glyburide. Surgical history is significant for multiple abdominal, left arm, testicle, right eye, and left leg shrapnel injuries in 1969 with notable lower extremity reconstructive procedures using skin grafts for trauma sustained from a grenade during the Vietnam conflict. Social history includes 40+ pack-years of smoking. Wound care for the past 20 years consisted of Unna’s boots and various over the counter medications and dressings. At the beginning of August patient was brought to the emergency room with an acutely infected and painful ulceration.

Figure 3  Case #2, the left lateral leg at initiation of EPIFLO® therapy on November 19, 2004.

After resolution of the infection, patient continued to have a visual analog pain scale of 10/10. Physical exam reveals palpable dorsalis pedis and posterior tibial pulses. Uniformly warm temperature noted and capillary fill intact to digits. Diffuse varicosities were noted bilaterally. The painful left calf ulceration measured approximately 3 cm x 5 cm x 0.5 cm depth with a mixed fibro-granular base and non-necrotic edges. No hyperkeratosis, tracking, probing, undermining, odor, or fluctuance was noted. There was minimal clear drainage. Conventional wound care modalities were initiated including compression therapy. Despite meticulous wound care, consults to vascular, pain management, diabetes management, infectious disease, and nutrition, the wound increased in size to 15 cm x 8 cm x 0.5 cm. The wound remained excrutiatingly painful and patient was routinely prescribed narcotics for relief.

TCOT was initiated with the following regimen of hydrogel to the wound bed, restore to periphery, and EPIFLO® unit to the wound bed under occlusion with Tegaderm. Due to a reaction, all adhesives were discontinued. Patient related that the wound pain was gone within weeks of initiating EPIFLO®.  TCOT regimen consisting of weekly replacement remained in place over the next 5 months with continued healing as evidenced by a decrease in wound size.

Patient eventually presented with and was diagnosed with a DVT and received treatment. Changes on plain film radiographs were concerning and confirmed by bone scan as osteomyelitis. Six weeks of intravenous (IV) antibiotics were instituted. By the end of EPIFLO® therapy the ulceration had decreased in size to 1.0 cm x 2.0 cm. (Fig. 4)

Figure 4  Case #2, the left lateral leg after 6 months of EPIFLO® therapy.  In addition to EPIFLO® therapy patient was successfully treated for underlying osteomyelitis of the fibula with 6 weeks intravenous (IV) antibiotics.

Case 3

A 48 year-old male patient who developed a major wound dehiscence was the third patient treated with TCOT. Following a traumatic head injury, the patient was left an incomplete quadriplegic. He was confined to a wheelchair, and over a period of 6 years post injury the feet and ankles progressively assumed rigid adductovarus flexion contractures, resulting in adult acquired clubfoot deformities. (Fig. 5) This rendered the patient unable to wear normal shoegear, and the lateral ankles were chronically ulcerated and often infected. The patient underwent surgery to re-position and stabilize the left foot in order to make it possible to heal and then prevent chronic ulcerations of the lateral ankle, as well as allow the patient to wear normal shoegear. With no tension on the skin, the lateral incision healed uneventfully, however, the medial incision began to break down shortly after surgery.

Figure 5  Case #3, the clinical pictures of bilateral deformities prior to surgical intervention on December 2, 2004.

It was treated with a variety of wound care modalities over a short period of time as the wound changed. There was no improvement seen and it progressed to a large wound with a fibrotic base and advancing necrosis. At one point it measured 7cm in length and 3cm in width at its widest point. (Fig. 6) TCOT was initiated and the wound breakdown appeared to halt. Therapy was continued, in conjunction with saline wet to dry dressings and the wound successfully healed fully in 11 Weeks. (Fig. 7) Following complete healing, the right foot and ankle were operated on, which healed uneventfully. The lateral ankle ulcerations did not recur and the patient was able to wear normal shoegear. (Fig. 8)

Figure 6  Case #3, the left medial incision wound at initiation of EPIFLOÒ therapy on December 18, 2004.

Figure 7  Case #3, the application of EPIFLOÒ device under occlusive dressing for treatment of left medial incision wound.

Figure 8 Case #3, the left medial incision wound at complete healing on March 14, 2005.

Case 4

A 71 year-old male patient with a non-healing painful ulceration was the fourth patient treated with TCOT. By history, the patient had sustained a major crush injury and underwent a triple arthrodesis procedure in 1962. The surgery was a success, but the patient was left with an asymptomatic hypertrophic scar with overlying callus.

For decades this was maintained with callus debridement as needed. At the time the patient presented to our clinic, his chief complaint was an ulceration which he stated had been discovered when the callus was recently debrided. (Fig. 9) The wound had been present for 4 weeks and was described as extremely painful, so severe that he was unable to bear any weight on his heel. The ulcer was located at the plantar medial aspect of the left foot, and measured 1.5 cm x 0.5 cm). The patient described the pain as a level of 10 using standard pain scale. There was some surrounding erythema and edema, and a deep necrotic core. Surgical debridement of the ulcer and scar revision was performed. The patient was treated with appropriate antibiotics. The erythema and edema resolved, but the wound healing was delayed and it remained painful at a level of 10. Over the next few weeks the wound was treated with a variety of conventional wound care modalities, but there was little improvement in the appearance of the wound and the patient required narcotics for the pain. It progressed to a deep wound which measured 3 cm x 2 cm x 2 cm depth.

Figure 9  Case #4, the left plantar wound at initiation of EPIFLOÒ therapy on January 3, 2005.

TCOT with EPIFLO® device was initiated and soon after the patient related that the pain was significantly relieved. He was able to bear weight and discontinued all pain medications. The wound began to granulate and decrease in size. Therapy was continued, in conjunction with saline wet to dry dressings and the wound successfully healed fully in 8 weeks. The ulcer did not recur. (Fig. 10)

Figure 10   Case #4, the left foot at complete healing on February 25, 2005.

Conclusion

Wound healing is a complex, multi-factorial biologic process that requires successful mobilization and integration of cells to repopulate the wound. This is orchestrated at least in part by a number of growth factors and is dependent in all phases of wound healing on the presence of adequate oxygen at the cellular level. Impairment of this process can be caused by the inadequacy of or lack of synchrony between critical factors. [27] It is widely acknowledged that limited oxygenation of the wound site results in delayed wound healing. In fact, angiogenesis is widely considered a rate-limiting factor in wound healing. [25]

The authors present 4 cases of non-healing painful wounds, recalcitrant to multiple forms of therapy. In all four cases, complete healing of the wound as well as obliteration of pain was achieved with use of TCOT using EPIFLO®.  This device delivers 3ml per hour of pure oxygen with ambient humidity directly to the wound site. The device is disposable and weighs only a few ounces and it is very patient and doctor-friendly. While success has been achieved with these four cases, further studies testing the potential of this delivery system for TCOT in pre-clinical and clinical settings are warranted.

References

1. Priestley J: The Discovery of Oxygen. Edinburgh the Alembic Club 1775. Presented by the University of Chicago Press, 1923
2. Spinal Rehabilitation Group: History of Hyperbaric Medicine, Melbourne Australia.
3. Neumeister M: Hyperbaric oxygen therapy. Emedicine 7, 2005. www.emedicine.com/plastic/topic526.htm accessed 08/28/2009.
4. Henshaw N: A Register for the Air, In Five chapters. Dublin, 1664.
5. Undersea Medical Society: Hyperbaric Oxygen Therapy. A Committee Report. Undersea Medical Society Publication, Inc Bethesda, MD, 1979.
6. Jacobson JH, Morsch JHC, Rendall-Baker L: Historical perspective of hyperbaric therapy. Ann NY Acad. Sci 117: 651 – 670, 1965.
7. Gottrup F: Measurement and evaluation of tissue perfusion in surgery. Leaper DJ, Braniicki FJ, (editors) In International Surgical Practice. Oxford University Press 15 -39, 1992.
8. Gottrup F: Oxygen in Wound Healing and Infection World J. Surg 28 (3) 312 – 315, 2004.
9. Hopf HW, Hunt TK, West JM, Blomquist P, Goodson WH 3rd, Jensen JA, Jonsson K, Paty PB, Rabkin JM, Upton RA, von Smitten K, Whitney JD: Wound tissue oxygen tension predicts the risk of wound infection in surgical Patients. Arch Surg 132: 997 – 1004, 1997.
10. Illingworth CF, Smith G, Lawson DD, Ledingham IM, Sharp GR, Griffiths JC: Surgical and physiological observations in experimental, pressure chambers. Brit J Surg 49:111 – 117, 1961.
11. Duff JH, Shibata HR, Vanschaik L, Usher R, Wigmore RA, MacLean LD: Hyperbaric oxygen: A review of treatment on eight patients. Can Med Assoc J 97: 510 – 515, 1967.
12. Heng MCY: Topical Hyperbaric Therapy for Problem Skin Wounds. Derm Surg Onco1 19: 784 – 793, 1993.
13. Heng MCY, Kloss SG: Endothelial cell toxicity in leg ulcers treated with topical hyperbaric oxygen. Am J Dermopathology 8:403 – 410, 1986.
14. Feldmeier JJ, Hopf HW, Warriner III RA, Fife CE, Gesell LB, Bennett M: UHMS position statement: topical oxygen for chronic wounds. UHM 32 (3): 157 – 168, 2005.
15. Heng MCY, Harker J, Csathy G, Marshall C, Brazier J, Sumampong, Paterno Gomez RN: Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. Ostomy Wound Management 46: 18 – 32, 2002.
16. Morgan JE: Topical therapy of pressure ulcers. Surg Gynecology Obstetrics 141:945 – 947, 1975.
17. Diamond E, et al. The effect of hyperbaric oxygen on lower extremity ulcerations. J Americ Podiatry Assoc 72:18 – 125, 1982.
18. Heng MCY: Local hyperbaric oxygen administration for leg ulcers (letter). Brit J Dermatology 109: 232 – 234, 1983.
19. Ignacio DR, Pavot AP, Azer RN, Wisotsky L: Topical oxygen therapy treatment of extensive leg and foot ulcers. J Am Podiatr Assoc 75:196 – 199, 1985.
20. Kwiecinski MG: Therapeutic value of hyperbaric oxygen in lower extremity ulcerations. J Foot Surgery 26:394 – 396, 1987.
21. Upson AV: Topical hyperbaric oxygenation in the treatment of recalcitrant open wound: a clinical report. Phys Ther 66 (9):1408 – 1412, 1986.
22. Heng MCY: Hyperbaric oxygen therapy for pyoderma gangrenosum. Aust. New Zealand J Med 14:618 – 621, 1984.
23. Kalliainen LK, Gordillo GM, Schlanger R, Sen CK:. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophys 9: 81 – 87, 2003.
24. Leslie CA, Sapico FL, Ginunas VJ, Adkins RH: Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers. Diabetes Care 1 (2), 111 – 115, 1988.
25. Fischer BH. Topical hyperbaric oxygen: treatment of pressure sores and skin ulcers. Lancet 23 (2): 405 – 409, 1969.
26. Ishii H, Ushida T, Tateishi T, Miyanaga Y: Effects of Transcutaneous topical injection of oxygen on vascular endothelial growth factor gene into the healing ligament in rats. J Orthopedic Research 21: 1113 -1117, 2003.
27. Fries RB, Wallace WA, Roy S, Kuppusamy P, Bergdall V, Gordillo GM, Melvin WS, Sen CK:. Dermal excisional wound healing in pigs following treatment with topically applied pure oxygen. Mutation Research 579: 172 – 181, 2005.
28. Gordillo GM, Roy S, Khanna S, Schlanger R, Khandelwal S, Phillips G, Sen CK: Topical oxygen therapy induces vascular endothelial growth factor expression and improves closure of clinically presented chronic wounds. Clinical Experimental Pharmacology Physiology 35 (8): 957 – 964, 2008.
29. Said HK, Hijjawi J, Roy N, Mogford J, Mustoe T: Transdermal sustained delivery oxygen improves epithelial healing in a rabbit ear wound model. Arch Surg 140 (10): 998 – 1004, 2005.
30. Banks PG, Ho C: A novel topical oxygen treatment for chronic and difficult-to-heal wounds: Case studies. J Spinal Cord Med 31(3): 297 – 301, 2008.


Address correspondence to: Danae Lowell, DPM (W112). Louis Stokes Cleveland Department of Veterans Affairs Medical Center. 10701 East Blvd Cleveland, OH 44106. 216-791-3800 Ext 5891

Staff Podiatrist and Assistant Residency Director. Louis Stokes Cleveland Department of Veterans Affairs Medical Center. 10701 East Blvd Cleveland, OH 44106
Staff Podiatrist. Pittsburgh Veterans Affairs Healthcare System. University Drive C. Pittsburgh, PA 15240. 412-688-6000 ext. 606795.
3  7244 Sprinside Drive, Fairview, PA 16145. 814-397-2091. Submitted while a second year resident.
Dynamic Foot Care. 554 Whitepond Drive. Suite A. Akron, Ohio 44320. 330-869-0669. Submitted while a second year resident.
Fellow, American Health Network. 128 Pine View Drive Apt. 6. Carmel, IN 46032. 216-789-8601. Submitted while a fourth year student.

© The Foot and Ankle Online Journal, 2009