Tag Archives: ankle reflex

Distant Intentionality Healing (DIH): A randomized double blind study on post operative care and cost to care for complications following foot and ankle surgery

by Gerald T. Kuwada, MPH, NMD

The Foot and Ankle Online Journal 5 (1): 1

A randomized double blind study was completed to determine the efficacy of Distant Intentionality Healing (DIH) on post operative complications following foot and ankle surgery. The results indicate that there is significant difference between the control group and the group receiving DIH p< .05 level of significance. The cost to care for complications was also significant with the DIH complication being $393/adverse event and the control group being $985/adverse event. The national average is $1388/adverse event.

Key Words: Monofilament, tuning fork, ankle reflex, superficial pain, neuropathy.

Accepted: December, 2011
Published: January, 2012

ISSN 1941-6806
doi: 10.3827/faoj.2012.0501.0001

In 2007 US health care cost 2 trillion dollars, the most expensive health care system in the world. Yet, according to the WHO (World Health Organization) the US health care system is ranked 37th in the world based on quality of care, fairness of the health care system and accessibility for the poor. [1] Part of the cost of health care in the US is from the 45 million operations performed in 2007. Of these cases, 25 million operations were performed under general anesthesia. There were 18 million adverse events after the operations or a rate of 40%. The cost to care for these adverse events was 25 billion dollars or 1,388 dollars per adverse event. [2]

The most frequent complication was SSI (surgical site infection) at 40%. Venous thromboemboli was second most frequent complication followed by postoperative cardiac event and fourth respiratory failure. In orthopedic cases, death occurred in about 0.92% of the operations in the US. [3] The range of cost to care for adverse events was 600-50,000 dollars. Complications are not only catastrophic to the patient and family, in the US 50% of the bankruptcies filed were due to medical expenses for health care and included patients with medical insurance. [2] This is not the case for patients in Canada, England, and France who have a form of universal health care.

Thus, if surgeons could reduce or eliminate the high complication rate substantially, this would be of great benefit to the patient and reduce the overall health care cost. Such a benefit might be possible with what is called Distant Intentionality Healing(DIH) or SHT (Samadhi Healing Technique) used by the healer.

What is Distant Intentionality Healing (DIH)? DIH is the mental intention to benefit another human being, living organism and human events. These mental intentioned techniques include prayer, Reiki, Therapeutic Touch, Samadhi Healing Technique (author uses this technique), Chi Kung and other human energy based techniques. Previous prospective randomized double blind studies have demonstrated the efficacy of DIH on postoperative pain reduction following foot and ankle surgery. [6] DIH patients had significantly less pain postoperatively, more patients had complete pain relief postoperatively and greater pain reduction compared to the control group. Furthermore, other studies have shown significant benefit to patients who received DIH with autoimmune disease (AIDS) and coronary artery disease (CAD) as a result of acute myocardial infarct (MI). [7,8]

Patients receiving DIH had fewer complications, less doctor visits and took less medications contrasted to the control group with AIDS. [7] Similarly, patients admitted to the hospital for acute MIs had no recurrence of MI, had less cardiac damage to the ventricle, had less complications, and recovered faster than the control group patients.8 Other healing modalities such as Reiki, Chi Kung and Therapeutic Touch have also demonstrated pain reduction post operatively for surgical patients. [9-12]

The first question to be answered by this study is can DIH reduce the incidence of postoperative complications following foot and ankle surgery compared to the control group? The second question is, can DIH decrease the cost to care for complications following foot and ankle surgery compared to the control group and the national average?


The study follows the guidelines from the Helsinki declaration of 1975 and modified version of 2000. Each patient reviewed and signed consent forms agreeing to participate in this research study. They were informed of any potential harm or side effects and the nature of the study (surgical complications).

There were a total of 195 patients in this prospective study which took 4 years to complete. Eighty-seven patients had 98 surgical procedures were randomly selected for DIH –SHT group. The control group comprised of 107 patients having 125 surgical procedures performed on them. The DIH-SHT group received the healing energy twice per day for 2 minutes each session for up to 4 weeks after their surgery. The surgeon is the healer in this study and performed surgery on all 195 patients. Both groups were not informed of what group they were assigned.

The healer was not informed by the research assistant which patients were assigned to the control group or the DIH-SHT group. Table 1 lists the procedures performed on the patients. Table 2 lists the complications that were recorded for each patient in their group and what procedures were performed on them. Table 3 lists the cost of care for the control group complications and the DIH-SHT group complications. The patients in both groups were followed for a minimum of 6 months after their surgery.

Table 1  List of operative procedures performed. SHT: Samadhi Healing Technique.

Table 2   Number of complications per procedure.  AD:  Adhesion, CP:  Chronic pain, CRPS:  Chronic regional pain syndrome, R:  Recurrence, SI:  Superficial infection.

Table 3   Cost to treat postoperative complications.

The healer performed DIH (specifically called Samadhi Healing Technique or SHT) twice per day at 5 a.m. and midnight daily for the 4 week period for patients immediately after their surgeries. The healer visualized patients and with intention, projected the thought of no complications to group DIH-SHT patients even though the healer did not know who they were. The DIH-SHT group patients were not told if and when they were receiving such intentional healing during the 4 week period post operative. At the end of 6 months postoperative, complications were documented from their medical records. If there were complications, the cost of care was also documented from their medical financial records and used for calculations in Table 3 for both groups.


The results indicate significantly less postoperative complication rate with p

The 2 in the DIH-SHT group were nail spicules after partial matrixectomy. For Table 1, of the 9 operatory categories, each operative procedure had complications for the control group. The DIH-SHT group had 4 surgical category procedures where complications were reported. There were 5 surgical categories where patients did not have complications in the DIH-SHT group. In Table 3, of the 20 complications the control group had 5/20 and the DIH group had 4/20 categories. As for the cost of caring for complications from both groups, the DIH-SHT group averaged $393 per adverse event. The control group had an average of $985 / per adverse event. The national average was $1,388 / per adverse event. The total cost of treating DIH-SHT complications was $3,536 and for the control group the cost was $23,634.


There is a significant reduction in complication rate for the DIH-SHT group patients at p

Previous studies have also corroborated significant postoperative pain reduction after foot and ankle surgery. There were no reported side effects of DIH-SHT treatment, no complications, and no extra medical costs incurred by the patient. The healer (author and surgeon) uses a DIH technique as previously described as SHT or Samadhi Healing Technique. The technique incorporates meditation, Samadhi or state of higher consciousness, focus, visualization and intentionality. The DIH energy is imagined to encircle all group B or DIH group patients even though the healer does not know who these patients are. The patients are unaware of when they receive the DIH healing intention.

The specific intention of no complications is transferred to the patient’s consciousness even though they are unaware that they have received the DIH energy. Not all patients were free of complications in the DIH group. This is attributed to either non-compliance by the patient regarding postoperative instructions or the patient was not susceptible to the DIH healing. Using the same DIH-SHT technique in other studies by the author there was significant reduction in postoperative pain, less pain medication used, and distance didn’t appear to affect the DIH-SHT effect. [6,7]

Currently there is no accepted physics paradigm that explains how DIH and SHT works. Recently, physicists postulated that DIH may be explained by the theory of entanglement and non-locality found in quantum mechanics. [13] According to these theories, protons of complex and separate systems entangle and interact with each other. [14]

Thus electrons vibrating in synchrony can be separated by several inches to billion light years away and point A and point B will receive the same message at about the same time despite the distance between the protons or electrons. The entanglement allows the message to be sent faster than the speed of light.

A recent study revealed neurons from separate preparations connected to each other. [14] The non-locality theory reveals that there is no central location in the brain where our consciousness can be located and identified. Yet, the healer and recipient can connect as documented by EEG studies when the recipient’s brain wave synchronizes with the healer’s brain wave during a healing session. [15]

During mystical, meditative and spiritual states, using SPECT or single photon emission computed tomography scans showed reduced brain metabolic activity in the posterior parietal lobe during intense or peak religious moments in Tibetan meditators and Franciscan nuns. [16]

In another study, meditation was shown to decrease anxiety and enhance positive emotional feelings and increase the immune response. [17] In five people who practiced Kundalini yoga, changes were noted in the area of the autonomic nervous system. This included the dorsolateral, prefrontal and parietal cortices, hippocampus, temporal lobe and the anterior cingulated cortex. [18]

Meditation is a vital part of SHT used by the author. It is preparatory prior to connecting to the patient and allows the healer to move into Samadhi or higher consciousness. During Samadhi, the patient is connected to the healer consciously and the intention is directed to the patient in the form of no complication for the patient after surgery.

In a landmark study by Achterberg et al., using functional MRI on 11 recipients paired with 11 different healers of various DIH disciplines, found that the anterior and middle cingulated, frontal lobes and precuneus were activated by the healers in their recipients. [19] The anterior and middle cingulated are associated with control and decision making for verbal and motor responses. The frontal lobe is regarded as the information processing center, judgment and decision making. The precuneus is associated with a wide spectrum of highly integrated neural tasks including visiospatial imagery, episodic memory retrieval, self-processing operations and rest. It has been found that the posterior medial precuneus has one of the highest resting metabolic rates or hot spots in the brain. It has been hypothesized that selective hypometabolism in this area of the brain occurs during a wide range of altered states of consciousness such as sleep, drug induced anesthesia, and various vegetative states. [20] It is postulated that this highly integrated neuronal network connects the autonomic and endocrine systems during DIH enhancing its intention within the recipient.

Achterberg did not perform functional Magnification Resonance Imagery (fMRI) on the healers’ brain during the healing session. The various DIH techniques used in this study have not been extensively studied in terms of its efficacy and reliability, including the healers abilities.

Lastly, DIH-SHT benefits patients based on this study and others and may have more widespread applications such as augmenting other treatment modalities for various diseases such as cancer. The author will study via fMRI brain activity during SHT in both the healer and patients.


DIH-SHT is a real phenomena based on over 2,000 scientific studies including this one. [14] The DIH-SHT technique has demonstrated repeated efficacy in postoperative pain reduction, decreased postoperative use of narcotic analgesia and decreased complications following foot and ankle surgery. Furthermore, there is evidence from functional Magnification Resonance Imagery( fMRI) and other imaging devices that DIH-SHT affects certain parts of the “recipients’’ brain during the healing sessions.

There are other benefits using DIH-SHT technique such as no side effects, no toxicities, no complications and no deaths as a result of incorporating this modality in our postoperative management. This is a tremendous benefit that helps our patients reduce the cost of caring for expensive postoperative complications. This reduces or eliminates the burdensome medical care costs forcing patients into an untenable financial situation necessitating bankruptcy. Further studies of DIH-SHT will focus on fMRI studies on the healer’s brain during the healing session and a wider application on other diseases like diabetic foot ulcers and cancers for example.

Foot and ankle surgery poses less serious surgical risks than other surgeries based on this study. A majority of procedures were digital procedures which comparatively poses less risk to patients than abdominal surgery for example.

This skews the outcome and may be the reason for the low incidence of serious complications in foot and ankle surgeries contrasted to other major organ surgeries. However, I have seen patients lose their toes after simple digital surgeries including matrixectomies performed by other surgeons. Traumatic and careless tissue handling including compromise of the delicate circulatory network will result in loss of blood flow to the toe resulting in gangrene and eventual loss of the toe. Thus, all surgical procedures have some degree of risk to the patient including the simplest types to the most complex. Adding DIH-SHT postoperatively decreases the sequelae of complications and improves the surgical outcome significantly.


1. World Health Organization. World Health Report 2000. Geneva. WHO: 2000. [pdf]
2. Fitzgerald, J., Kanter, G., Trelease, R., Benjamin E. Nursing Management Nov. 2007, Vol. 30, No. 11 page 35-39.
3. Bhattacharya T, Iorio R, Healy L. Rate of risk factors for acute inpatient mortality after orthopedic surgery. JBJS 2002 84: 562-572. [PubMed]
4. Kuwada, GT, Distant Intentionality Healing for reduction of postoperative pain following foot and ankle surgery. A randomized, double Blind study. Submitted to the Journal of Alt. and Complementary Med. 2010. (Not published)
5. Kuwada, GT. Distant Intentionality Healing for reduction of narcotic analgesia following foot and ankle surgery. A randomized, double blind study. Submitted to the Journal of Consciousness. 2010. This is an invalid reference as it stands.
6. Sicher F, Targ E, Moore D, Smith HS. A randomized double blind study of the effect of distant healing in a population with advanced AIDs – report of a small scale study. Western Journal of Medicine. 1998 169: :356-363. [PubMed]
7. Harris W, Gowda M, Kolb KW, Strychacz CP, Vacek JL, Jones PG, Forker A, O’Keefe JH, McCallister BD. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Internal Medicine 1999 159: 2273-2278. [PubMed]
8. Jonas, W., Crawford, C. (eds.) Healing, Intention and Energy Medicine: Science, Research Methods and Clinical Implications. 2003. London: Harcourt.
9. Gerber, R. Vibrational Medicine. 3rd edition. 2001. Bear and Company. Rochester, VT.
10. Olson K, Hansen J. Using Reiki to manage pain: A preliminary report. Cancer Prevention Control 1997 1: 108-113. [PubMed]
11. Gordon R. Quantum Touch: The Power to Heal. 2002 North Atlantic Books, Berkley, CA.
12. Einstein, A., Podolsky, B., Rosen, N. Can Quantum Mechanical description of physical reality be complete? Phys. Rev. 19355:47: 777-780.
13. Pizzi R, Fantasia A, Gleain F. 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.
14. Charman RA. Placing healers, healees and healing into a wider research context. J Alter Complementary Medicine 2000 6: 177-180. [PubMed]
15. Shealy C, Smith N, Liss T, Borgmeyer S. EEG Alterations during healing. Subtle Energies 2000 11: 241-248.
16. D’Aquila EG, Newberg AB. Mystical states and the experience of God: A model of the neuropsychological substrate. Zygon J Religion Sci 1993 28 177-200.
17. Davidson RJ, Kabat-Zinn J, Schumacher J, Rosenkranz M, Muller D, Santorelli SF, Urbanowski F, Harrington A, Bonus K, Sheridan JF. Alterations in brain and immune function produced by mindfulness meditation. Psychosomatic Medicine 2003 65: 564-570.
18. D’Aquila EG, Newberg AB. The neuropsychology of aesthetic, spiritual and mystical states. Zygon: J Religion Sci 2000 35: 39-51.
19. Standish L, Johnson J, Clark L, Todd R, Kozak L, Richards T. Evidence of correlated fMRI signals between distant human brains. Alt Therapies in Health 2003 9: 122-128. [PubMed]
20. 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.
21. Lazar S, Bush G, Gollub RL, Fricchione GL, Khalsa G. Benson H. Autonomic Nervous System: Functional Brain Mapping of the Relaxation Response and Meditation. Lippincott,Williams & Wilkins, Inc. 2000.

Address correspondence to: Gerald T. Kuwada, DPM, NMD. 275 SW 41st Street, Renton, WA. 98057. Phone 425-251-9174, Fax 425-251-0758. Email: drgeraldkuwada@qwestoffice.net.

1  Private practice, 275 SW 41st street, Renton, WA 98057.

© The Foot and Ankle Online Journal, 2012

A Comparison of the Effects of First Metatarsophalangeal Joint Arthrodesis and Hemiarthroplasty on Function of Foot Forces using Gait Analysis

by Callaghan, M.J.1,2  ,Whitehouse, S.J., Baltzopoulos, V., Samarji, R.A.1

The Foot and Ankle Online Journal 4 (12): 1

Background: Arthroplasty or hemiarthroplasty for hallux rigidus of the first metatarsophalangeal (1st MTPJ) is thought to lead to greater joint motion and improved gait function. There have been no studies to compare the effects of 1st MTPJ arthrodesis and hemiarthroplasty on joint kinetics, kinematics and plantar pressures of foot and lower limb.
Methods: A retrospective, case series pilot study approximately 22 months post operation. Subjects had either arthrodesis or a NorthStar HemiCAP hemiarthroplasty for osteoarthritis of the 1st MTPJ. All had plantar pressure, kinetic and kinematic gait analysis as well as the Foot and Ankle Outcome Score (FAOS), and 1st MTPJ range of motion (ROM).
Results: For the hemiarthroplasty subjects the mean ROM on the non-operated 1st MTPJ was 490(SD23) but only190 (SD16) on the operated side. Kinetic and kinematic results for both operations were similar. Plantar peak pressure data showed that the arthrodesis group took more pressure under the 1st MTPJ in the stance phase. The arthrodesis group had higher FAOS scores (mean 95.6 SD 5.1) than the hemiarthroplasty group (mean 72.2 SD 18.8) indicating more satisfaction with their surgery.
Conclusions: Arthrodesis of the 1st MTPJ better FOAS scores, improved peak plantar pressure over the medial foot compared to a 1st MTPJ hemiarthroplasty. There were minimal differences in kinetic and kinematic data. Hemiarthroplasty patients had considerably reduced 1st MTPJ ROM compared to their non-operated side. We conclude that the North Star HemiCAP cannot be recommended at this time for the management of hallux rigidus. Arthrodesis remains the surgical treatment of choice.

Key Words: Monofilament,tuning fork,ankle reflex,superficial pain, neuropathy.

Accepted: November, 2011
Published: December, 2011

ISSN 1941-6806
doi: 10.3827/faoj.2011.0412.0001

First metatarsophalangeal joint (MTPJ) arthritis is a progressive, painful and debilitating condition also known as hallux rigidus. [1] The most common form of presentation is unilateral involvement in the older female patient with a gradual onset of pain and limited range of motion at the 1st MTPJ.

This often results in an abnormal gait pattern due to a shift in weight bearing from the first ray to the outer border of the foot [11] along the metatarsal heads transverse axis.

In a recent study on hallux rigidus [5] 90% of patients considered that their walking pattern had changed of which 33% considered that this change affected their everyday lives. Only 51 feet (28%) were able to push through the ground at propulsion, the remainder was affected to varying degrees of severity.

One hundred and thirty five feet (75%) rolled outwards during the propulsion phase of the gait cycle and it is claimed that these changes may be detrimental to a person’s gait.

Surgical treatments for hallux rigidus include arthrodesis, cheilectomy, excisional arthroplasty, metatarsal osteotomy, and total or hemiarthroplasty. Of these techniques, arthrodesis of the 1st MTPJ is regarded currently as the mainstay of surgical treatment [15], and is still considered the gold standard particularly in younger and more active patients. The technique is advocated for the alleviation of pain and deformity and restoration of the stability and weight bearing function of the first ray by stabilizing the medial column of the foot. [3,10] This technique has been shown to be successful both in pain relief and also in clinical and radiographic evaluation. [9] Despite the high patient satisfaction in terms of pain relief, 1st MTPJ arthrodesis has been shown to reduce functional gait parameters compared to the contralateral limb. For example, DeFrino et al., [6 ] using dynamic pedobarography on 10 feet, showed that 1st MTPJ arthrodesis produced a restoration of the weight bearing function of the first ray with greater maximum force carried by the distal hallux at toe-off. However, the same study also showed a statistically significant reduction in ankle torque and ankle power at push-off and a shorter step length and loss of ankle plantar flexion at toe-off. Similarly, Brodsky, et al., [3] compared pre and post operative arthrodesis data and found three statistically significant changes in gait: an increased single limb support time, a decrease in step length but an increase in maximum ankle push off power in contrast to the previous study. Although these finding were attributed to improvements in pain and mechanical stability, mechanics of the 1st MTPJ were not measured.

Stiffness resulting from an arthrodesis can lead to patient dissatisfaction with the arthrodesis technique. Normal gait patterns can be altered, with a decreased step length and some loss of ankle plantar flexion at toe-off on the fused side. [6] Additionally, the long term effects of a rigid first ray may not yet be apparent. [9]

An alternative and logical follow up is first MTPJ arthroplasty. Whether using a total or hemiarthroplasty, the aims of joint replacement are not only to provide pain relief but also restore motion of the first MTPJ, maintain joint stability with a concomitant improvement in function and gait. [12] Many different designs and solutions for arthroplasty have been proposed over time.

Evidence to support the increase in range of movement and improved gait is scanty and to date there has only been one randomized, controlled trial comparing arthrodesis to arthroplasty for hallux rigidus.   [9] This study compared 38 toes undergoing arthrodesis with 39 undergoing a Biomet unconstrained total arthroplasty. Pain was measured via a visual analogue scale (VAS) as well as patient self reported satisfaction, first MTPJ mobility using electrogoniometry and plantar foot pressures using pedobarography. The results showed that the arthrodesis group was statistically better in pain at 12 (p = 0.005) and 24 months (p = 0.01). First MTPJ range of motion in the arthroplasty group improved post operatively compared to the pre operative status, but not to a level of statistical significance. Gait analysis on an 8 meter walkway measured plantar foot pressures and showed that patients in both groups tended to weight bear on the lateral border of the foot. In the arthrodesis group, all fusion sites were united and had gained a significant improvement in pain levels. The authors were not in favor of total arthroplasty as several implants had to be removed due to loosening. They were not able to assess the effects of either procedures on other joints of the foot and ankle during walking due to the lack of kinetic and kinematic analysis.

A recent non-randomized retrospective study [13] compared the BioPro metallic hemiarthroplasty in 21 toes to first MTPJ arthrodesis in 27 toes and at 6 year follow up found inferior clinical and functional results in the arthroplasty group as assessed by the AOFAS Hallux Metatarsal Interphalangeal (AOFAS-HMI) score. There was no gait analysis of any kind performed.

Despite the theory that an arthroplasty would lead to greater first MTPJ motion and an improvement in gait function, there have been no studies to compare the effects of first MTPJ arthrodesis and hemiarthroplasty on both the joint kinetics and kinematics of foot and lower limb using gait analysis. These techniques combined in a specialist gait laboratory form a powerful and robust analysis of gait, joint mobility and muscle function. They would help our understanding of both procedures by providing information to assess the effects of each procedure on the other joints of the forefoot and gait mechanics and function in general, which are important for the long term prognosis of these techniques. We have identified some methodological issues arising from the studies cited: Firstly, there has been no gait analysis comparison of hemiarthroplasty with arthrodesis of the first MTPJ and their effects on foot and ankle kinetics and kinematics. Secondly, there has been no detailed analysis comparing the plantar pressure distribution of arthrodesis and hemiarthroplasty.

Therefore, the aims of this study were to observe any differences in kinematic, kinetic and plantar pressure measurements between first MTPJ hemiarthroplasty and first MTPJ arthrodesis. The study design took the form of a pilot study to ascertain technical feasibility and also to provide data exploring clinical significance and sample size for a future randomized controlled surgical trial.


This was a retrospective, case series pilot study.


All patients were identified from the patient operating list of the senior surgeon (RAS) and had surgery for non- inflammatory, symptomatic hallux rigidus. There were five patients (4 females) with first MTPJ arthrodesis (Age 58.2 ± 15 years, mass 70 ±7kg and height 164 ±8cm) and four female patients with first MTPJ hemiarthroplasty (Age 60.5 ± 7 years, mass 68±6 kg, height 159±3 cm). Descriptive statistics are listed in Table 1. The mean post operation time was 23 months after arthrodesis and 22 months after hemiarthroplasty. None of the subjects had experienced any post-operative complications such as superficial or deep infection, deep venous thrombosis, or complex regional pain syndrome. There were no cases of non-union or component loosening and none of the arthrodeses or hemiarthroplasties had been revised.

Table 1   Descriptive statistics of subjects.

Exclusion Criteria

Subjects were excluded from the study if they had undergone other foot and ankle surgery, other degenerative joint diseases of the lower limb, post infectious arthritis, rheumatoid arthritis or Charcot neuroarthropathy.

Surgical procedures

First MTPJ hemiarthroplasty

A NorthStar HemiCAP implant MTP resurfacing implant was used for all hemiarthroplasty patients. (Figure 1A and 1B) First, a dorsal approach to the first MTPJ was used to expose the joint. A guide pin was inserted into the first metatarsal head via the distal articular surface using a drill guide to aid location of the correct axis. A cannulated drill was then used to drill over the guide wire. The hole was tapped and a taper post inserted. A trial cap was placed on the taper post to determine whether the correct depth has been achieved. The trial cap was removed and a centering shaft and contact probe inserted to determine offsets at four index points. The articular component size was determined from a sizing card using these offset values. A circle cutter was used over the guide pin to score the articular cartilage down to subchondral bone. A surface reamer, size matched to the chosen articular component was used next. A final sizing trial was inserted and any necessary adjustments made. Finally, the actual articular components was inserted and impacted down.


Figure 1A and 1B  Plain radiographs anterior posterior (A) and oblique (B) views of the NorthStar HemiCAP prosthesis.

Post operatively, no plaster cast was applied. Patients were encouraged to fully weight bear as soon as possible without walking aides. In particular, a normal gait pattern was permitted in order to achieve dorsiflexion at the MTPJ at the push off phase of the gait cycle. A check radiograph was requested 6 week post operatively.

First MTPJ Arthrodesis

The first MTPJ arthrodesis was carried out under tourniquet through a dorsal longitudinal incision centered over the metatarsophalangeal joint. (Figure 2A and 2B) The dorsal sensory nerve was seen and protected throughout the procedure. A capsulotomy was carried out and the metatarsal head and proximal phalanx were denuded of articular cartilage using reamers to expose bleeding cancellous bone. They were coapted and held with a partially threaded cancellous small fragment screw with a washer. The toe was positioned taking reference from the heel with slight dorsiflexion at the MTPJ in a neutral rotation and slight valgus position. The wound was closed in layers.


Figure 2A and 2B  Plain radiograph anterior posterior (A) and oblique (B) views of the arthrodesis technique.

Post operatively, patients were required to strictly heel weight bear with the help of walking aides for 6 weeks. A plaster slab was put over the operation site, but did not include the ankle or lateral border of the foot. Graduated heel weight bearing and discarding of the walking aides was permitted after a check radiograph 6 weeks post operation.

Outcome Measures

The foot and ankle outcome score (FAOS)

The FAOS [14] is a patient administered score consisting of 5 subscales; i) pain, ii) other Symptoms, iii) function in daily living (ADL), iv) function in sport and recreation (Sport/Rec), and v) foot and ankle-related Quality of Life (QOL). The last week was taken into consideration when answering the questionnaire. Standardized answer options were given (5 Likert boxes) and each question got a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) was calculated for each subscale. The results were plotted as an outcome profile.

MTPJ Range of motion

A small finger universal goniometer with five degree increments was used to measure first MTPJ range of motion (ROM) in dorsiflexion and plantarflexion. This was done in supine lying with the heel resting on the examination couch and the ankle in a neutral position.

Gait analysis

Gait analysis was performed on a 10 meter m instrumented walkway at the gait analysis laboratory at Manchester Metropolitan University. Kinematic and kinetic measurements and plantar pressures are affected by walking speed so participants were instructed to walk at their normal comfortable speed after familiarization with the testing procedures.

Kinematic data were acquired using a three-dimensional (3D) optoelectronic motion analysis system (VICON Nexus, Oxford Metrics, Oxford, England) with ten high-resolution cameras sampling at 120 Hz.

The kinematic data was filtered with cross-validating quintic splines interpolation (QSI scheme) to reduce the noise from skin movement and other sources of coordinate recording errors. The standard biomechanical foot model used in typical gait analysis applications represents the foot as a single rigid body, allowing the assessment of only foot progression angle and net dorsi/plantar flexion. This is not adequate for the purpose of this study and the examination of the MTPJ function. For this reason we used the “Oxford Foot model” [4] which represented the foot using three rigid segments (hindfoot, forefoot and hallux). The relative motion between the segments was described without inter-segment constraints in this foot model. This was necessary to accommodate the likely conditions and constraints of hallux and forefoot function in the patients of this study. For the hindfoot, segment markers were placed on the lateral and medial malleolus two markers along the vertical axis of the calcaneus posteriorly and two additional markers on the lateral and medial sides of the calcaneus. For the Forefoot and Hallux segments markers were placed on the distal medial side of the 1st MTPJ, the distal lateral side of the 5th metatarsal joint, on the distal 2nd MTPJ, on the proximal 1st and 5th MTPJ, and two markers (proximal and distal) on the long axis of the hallux. For the other leg segments the standard Helen Hayes marker set was used as implemented in the Bodybuilder modeling package of the VICON system. Static trials were performed before the gait tests to allow the calculation of segment-embedded coordinate frames based on the positions of the anatomical landmarks that were identified from the coordinates of the surface markers and relevant subject anthropometric measurements. Kinematic parameters to include joint angles and kinetic measures including joint moments and plantar pressures were calculated at key moments in the stance phase of gait cycle (heel strike, foot flat, midstance, heel off and toe off) for comparisons between the operated and unaffected side of the two different groups of patients.

Kinetic (ground reaction force) data were collected at 1080 Hz using two Kistler force-plates (Kistler, Switzerland) that are embedded in the middle of the walkway.

Joint kinetics (resultant joint forces and moments) were calculated using standard inverse dynamics techniques by combining the kinematic and force plate data into a musculoskeletal mechanical model of the lower limbs. Data were normalized to body weight.

Plantar pressures were recorded during level walking with the participants wearing their own shoes. The Tekscan in-shoe plantar pressure system was used for these measurements (Tekscan, Boston, MA), sampling at a frequency of 40 Hz. The Tekscan Research Foot software was used to construct individual ‘‘masks’’ to determine maximum force (kg) and peak pressure (kg/cm2) under several regions of interest of the foot including the hallux, toes, metatarsals, midfoot and heel.
The pressures in the plantar surface of the foot during normal gait were examined with Tekscan in-shoe plantar pressure system using the F-Scan sensors (Model #3000E VersaTek). These sensors contain up to 960 individual pressure sensing elements, that which detect the subject’s plantar pressure.

These pressure elements are arranged in rows and columns on the sensor and their output recorded by the system during any activity is quantified into 256 increments. This digital value is then calibrated for pressure in kilopascals (KPa). The sensors were cut to size for each subject and were inserted in the shoes so that the pressures exerted between the foot and the shoe were recorded during the gait.

A “step” calibration procedure was followed where the subject is required to shift the weight to each foot in turn so that the full weight of the subject is sensed alternately by both sensors (left and right). According to the instructions of the manufacturer, this is the most appropriate calibration technique for dynamic activities such as gait because it contains a factor for rapid dynamic changes and compensates for time related changes in sensor output. Following the calibration procedure, the subjects were asked to walk in their normal gait speed on a flat gait walkway of approximately 10 meters, three times. The first two trials were used for familiarization with the instrumentation in the shoes and although data were collected from all three trials only the third (final) trial was analyzed.

Statistical Analysis

The analysis was in two parts. Firstly, there was a within groups comparison of the kinetic, kinematic and plantar pressure parameters at key moments of the gait cycle between the operated and non-operated side of each patient. Secondly, there was a between groups analysis of the same parameters between the arthrodesis and hemiarthroplasty patients. The small sample size precluded the use of formal statistical analysis. Comparison of the other data sets was made by analysis of the descriptive statistics and normalized data.


There were no adverse events from the gait analysis protocol.
The ROM for the 1st MTPJ measured by goniometry was 190 (SD16) for the hemiarthroplasty side were compared to 490(SD23) on the non-operated side. Figure 3 shows the differences in the post-operative ROM at 22 months.

Figure 3  Range of motion (ROM) at 1st MTPJ compared to non-operated side in hemi -arthroplasty patients.

The kinematic results are for the Oxford foot model maximum dorsiflexion and total ROM angles at the ankle and ROM at the 1st MTPJ. For the hemiarthroplasty patients the ROM angle at the 1st MTPJ was small compared to the non-operated side.

There was some measurable motion on the arthrodesis side which was smaller than the hemiarthroplasty. Reasons for the apparent contradiction of available motion in a fused joint are in the discussion. Ankle maximum ROM for dorsiflexion and total ROM were greater in the hemiarthroplasty side compared to the non-operated side and compared to the arthrodesis subjects. (see Table 2).

Table 2  Kinetic and kinematic data Means and (SD).  Legend: Max DF  =  maximum dorsiflexion, 1st MTPJ RoM = first metatarsophalangeal joint range of motion, % BW = percentage body weight.

The kinetic results from the force plate are for the peak medio-lateral force which is affected mainly by supination and pronation of the foot and ankle during the gait cycle from ‘heel strike’ to ‘toe off’. A higher ground reaction force in the lateral direction indicated more weight bearing on the medial side of the foot and the first ray. Compared to the non-operated side, the peak lateral force for both the arthrodesis and hemiarthroplasty sides was similar and slightly higher than the operated side. (see Table 2).

Table 3  Plantar Peak Pressure data for arthrodesis, hemiarthroplasty and non-operated foot. kPa means (SD).

The peak plantar pressures from the 1st MTPJ area are presented in Figure 4. The descriptive statistics are in Table 3. These data have several features. The peak plantar pressure area under the first metatarsal was higher on the arthrodesis side compared to the non-operated side (305 (SD 143 KPa) v 194 (SD 73 KPa)) indicating that this part of the foot was taking more pressure than those patients who had a hemiarthroplasty.

Figure 4  Mean Peak area plantar pressures under the first metatarsal head.

Furthermore, Table 3 shows that there was a tendency to take greater pressure on the 3rd, 4th, 5th metatarsal heads and the lateral side of the foot in the hemiarthroplasty patients. These data are illustrated in Figure 5 which shows a comparison between left side (normal) and right MTPJ arthrodesis and in Figure 6 which compares left (normal) and right MTPJ hemiarthroplasty. The differences between the plantar pressures at the first metatarsal area were difficult to assess through formal statistical analysis due to the small sample size.

Figure 5   Average peak stance data with center of force trajectory.  Patient was 24 months post right arthrodesis.

Figure 6  Average peak stance data with center of force trajectory.  The patient was 17 months post hemi-arthroplasty.

The FAOS scores are presented in Figure 7. These show that the arthrodesis patients (mean 95.6 (SD 5.1) scored higher in most of the subscales and on the overall score than those who had the hemiarthroplasty, (mean 72.2 (SD 18.8)

Figure 7   Foot and Ankle Outcome Score (FAOS).  Red = hemiarthroplasty, Blue = arthrodesis, 100 = normal FAOS score.


This study aimed to compare a small group of subjects who had undergone arthrodesis or hemiarthroplasty using the NorthStar HemiCAP prosthesis for hallux rigidus using several gait parameters. Our study had volunteers whose mean post operation time was at least 22 months, thus giving a good representation of the long term outcome of both surgical techniques.

Arthrodesis is generally considered a satisfactory operation for primary OA of the 1st MTPJ. The functional excellence and durability of the results obtained are impressive, although the loss of 1st MTPJ range of motion is an obvious drawback of the technique. [7] The value of prosthetic implants instead is still a theme for debate. The advantages of the procedure include preservation of the motion and a wide variety of implants have been proposed over time. [8] Nevertheless high risk of failure of the implant and serious complications have been reported. [6] The aims of this study were to compare one surgeon experienced in both techniques, to assess clinical efficacy and to use gait analysis methods to help explain any differences between the two operations.

The kinematic results indicated that hemiarthroplasty gave only a minimally improved ROM at the hallux, although there was greater movement for maximum ankle dorsiflexion. The discrepancy concerning detectable movement at the fused MTPJ is most probably due to movement of the skin and the markers used for the kinematic analysis relative to the bones.

The kinetic results showed that both techniques resulted in similar laterally directed forces in mid stance.

These data indicate that after both arthrodesis and hemiarthroplasty more force can be taken on the inside of the foot compared to the non-operated side. This is in contrast to the observations from the more detailed plantar pressure data which show increased medial foot and 1st MTPJ pressure after the arthrodesis, but not after hemiarthroplasty. It is tempting to infer that this was due to them having less pain at the fused joint and therefore having few problems assuming a normal gait.

This is the first study to use insole sensors to compare plantar pressures of arthrodesis and hemiarthroplasty of the 1st MTPJ. The plantar pressure results showed that the arthrodesis patients were adopting a gait which favored normal 1st MTPJ pressures, whereas the hemiarthroplasty patients, even 22 months post operation, were still favoring the lateral side toes and avoiding pressure under the 1st MTPJ.

These data also show the advantages of plantar pressure and the limitations of ground reaction force analysis in the context of this investigation. Plantar pressure techniques are able to capture more precisely the focal points of pressure distribution (see Figures 5 and 6) whereas force plate readings present a more generalized indication of the overall ground reaction forces generated during gait.

The FAOS shows that all the patients who had hemiarthroplasty were not satisfied with their operation and had continuing pain and stiffness in their toes and foot. Interestingly, only one patient who had arthrodesis considered that foot stiffness was a problem. Four out of five arthrodesis patients considered themselves pain free (i.e.) scoring ‘normal’ on the pain subscale) whereas only one in four of the hemiarthroplasty group considered themselves pain free.

These results are similar to the data from Raikin, et al., [13] comparing 1st MTPJ arthrodesis with the BioPro metallic implant. Post-operative scores (using the invalidated American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal Interphalangeal -AOFAS-HMI scoring system) of 93 for arthrodesis and 71.8 for hemiarthroplasty are very similar to our FAOS of 95.6 and 72.5 respectively. These two sets of results suggest that arthrodesis is superior to hemiarthroplasty in terms of patient self reporting of pain, function and stiffness. This is also the conclusion of systematic review which concluded that arthrodesis achieved better functional outcomes than hemiarthroplasty. [2]

The poor outcome using FAOS might explain why the first metatarsal pressure was always higher in the arthrodesis group. It seems that patients felt sufficiently pain free and confident enough to take pressure through this area of the foot. Our results on the arthrodesis patients concur with DeFrino, et al., [6] who also measured plantar pressures on 10 feet, to show that first MTPJ arthrodesis produced a restoration of the weight bearing function of the first ray with greater maximum force carried by the distal hallux at toe-off.

There are few comparative studies in the literature and none involving the NorthStar HemiCAP. This is the first data presented for this implant. Gibson & Thompson [9] compared a Biomet unconstrained total arthroplasty to arthrodesis.

Like these researchers, we found that the arthrodesis group had better pain scores at 24 months, although we used a FAOS rather than the VAS. Their gait analysis showed that patients in both groups tended to weight bear on the lateral border of the foot, whereas our plantar pressure and kinetic data showed a tendency for lateral foot pressure to be greater in the arthroplasty patients, with arthrodesis patients having increased pressure (and therefore increased weight bearing) under the medial foot and 1st MTPJ.


This study had some shortcomings. Patients were assessed retrospectively rather than prospectively, which may have affected preoperative scoring as it was based on chart review. Surgical treatment was not randomized, but was based on clinical need including patient’s preference with one surgeon performing the hemiarthroplasties and arthrodeses. The sample size was limited due to the number of NorthStar HemiCAPs which were performed and could be matched to an arthrodesis procedure.

Barefoot walking was preferred to standardized footwear for kinetic and kinematic analysis. This was decided due to the difficulty in obtaining funding for such footwear. However, all plantar pressure data used the patients’ own footwear in order to incorporate the insoles and this lack of standardization might be a confounding variable.


Arthrodesis of the 1st MTPJ results in better FOAS scores, improved peak plantar pressure over the medial foot compared to a 1st MTPJ hemiarthroplasty. There were minimal differences in kinetic and kinematic data. In the hemiarthroplasty patients, 1st MTPJ ROM was considerably reduced compared to their no-operated side.

Our results of the North Star HemiCAP concur with other studies using different implants that hemiarthroplasty cannot be recommended at this time for the management of hallux rigidus. Arthrodesis remains the surgical treatment of choice.


1. Coughlin MJ. Shurnas PS. Hallux rigidus. Grading and long-term results of operative treatment. JBJS 2003 85A: 2072-2088.
2. Brewster M. Does total joint replacement or arthrodesis of the first metatarsophalangeal joint yield better functional results? A
systematic review of the literature. J Foot Ankle Surg 2010 49: 546-552.
3. Brodsky JW, Baum BS, Pollo FE, Mehta H. Prospective gait analysis in patients with first metatarsophalangeal joint arthrodesis for hallux rigidus. Foot Ankle Int 2007 28: 162-165.
4. Carson MC, Harrington ME, Thompson N, O’Connor JJ, Theologis TN. Kinematic analysis of a multi-segment foot model for research and clinical applications: a repeatability analysis. J Biomech 2001 34: 1299-1307.
5. Beeson P, Phillips C, Corr S, Ribbans WJ. Hallux rigidus: a cross-sectional study to evaluate clinical parameters. Foot 2009 19: 80-92.
6. DeFrino PF, Brodsky JW, Pollo FE, Crenshaw SJ, Beischer AD. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study. Foot Ankle Int 2002 23: 496-502.
7. Fitzgerald JA. Wilkinson JM. Arthrodesis of the metatarsophalangeal joint of the great toe. Clin Orthop Rel Res 1981, 70-77.
8. Giannini S, Vannini F, Bevoni R, Francesconi D. Hallux Rigidus: Arthroplasty or not? G. Bentley (ed.), European Instructional Lectures. European Instructional Course Lectures 9, pages 239-246.
9. Gibson JN. Thomson CE. Arthrodesis or total replacement arthroplasty for hallux rigidus: a randomized controlled trial. Foot
Ankle Int 2005 26: 680-690.
10. Kitaoka HB, Holiday AD, Jr., Chao EY, Cahalan TD. Salvage of failed first metatarsophalangeal joint implant arthroplasty by implant removal and synovectomy: clinical and biomechanical evaluation. Foot Ankle 1992 13: 243-250.
11. Mann RA, Coughlin MJ, DuVries HL. Hallux rigidus: A review of the literature and a method of treatment. Clin Orthop Rel Res 1979 57-63.
12. Olms K. Dietze A. Replacement arthroplasty for hallux rigidus. 21 patients with a 2-year follow-up. Int Orthopaedics 1999 23: 240-243.
13. Raikin SM, Ahmad J, Pour AE, Abidi N. Comparison of arthrodesis and metallic hemiarthroplasty of the hallux metatarsophalangeal joint. JBJS 2007; 89: 1979-1985.
14. Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int 2001 22: 788-794.
15. Vanore JV, Christensen JC, Kravitz SR, Schuberth JM, Thomas JL, Weil LS, Zlotoff HJ, Mendicino RW, Couture SD. Diagnosis and treatment of first metatarsophalangeal joint disorders. Section 2: Hallux Rigidus. J Foot Ankle Surg 2003 42: 124-136.

Address correspondence to: Michael Callighan, Manchester Royal Infirmary, Manchester,UK. E-mail: michael.callaghan@manchester.ac.uk

1  Manchester Royal Infirmary, Grafton Street, Manchester, UK.
2  University of Manchester, Oxford Road Manchester, UK.
3  Manchester Metropolitan University, John Dalton Building Manchester, UK.

© The Foot and Ankle Online Journal, 2011

Simple Screening Tests for Peripheral Neuropathy as a Prediction of Diabetic Foot Ulceration

by Ghada M. Morshed MRCS, MD1, Mohamed A. Mashahit MD2, Hala A. Shaheen, MD3

The Foot and Ankle Online Journal 4 (11): 2

Background and Objectives: Diabetes mellitus is one of the major health problems, and one of its commonest complications is peripheral neuropathy. The aim of this study is to evaluate four standard simple screening tests (10-g Semmes-Weinstein monofilament examination {SWME}, vibration sensation by a 128Hz tuning fork, superficial pain test and ankle reflex) for detection of neuropathy using the nerve conduction study ( NCSs) as the standard criterion in diabetic patients.

Methods: The study included 120 patients with diabetes mellitus, all patients had complete clinical assessment including presence or absence of neuropathy, exclusion of other causes of neuropathy, NCS,10 g Semmes-Weinstein monofilament examination, vibration sensation by a 128 Hz tuning fork ,superficial pain sensation and ankle reflex were done for all patients.

Results: Foot care practices were followed by 80 (66.6%) of the study population. When compared with NCSs, the monofilament was the most specific at 91%, less sensitive 57%, superficial pain, ankle reflex had lower specificity (36%, 41%) respectively, sensitivity (62%,57%) respectively. Tuning fork had specificity 90%, sensitivity 56%.

Conclusion: The study findings show that the simple screening tests (10-g SWME, vibration testing ,superficial pain test and ankle reflex) can be used confidently for annual screening of diabetic neuropathy in diabetic patients.

Key Words: Monofilament-tuning fork-ankle reflex-superficial pain-neuropathy.

Accepted: October, 2011
Published: November, 2011

ISSN 1941-6806
doi: 10.3827/faoj.2011.0411.0002

Diabetes mellitus is considered as a major health problem and one of its commonest complications involves the feet. Diabetic foot problems may lead to lower limb amputation which occurs commonly in uncontrolled diabetics. The chronic peripheral neuropathy which is associated with diabetes presents progressively and insidiously with poor symptoms related to the pathological severity. [1,2]

Peripheral neuropathy initiates the pathophysiology to leg ulceration and may be amputation and it is the main cause for sensory ataxia, painful paresthesia, and Charcot deformity. [3] Early identification and screening of neuropathy offer an important opportunity for the diabetic patient to actively alter the suboptimal glycemic control and improve foot care prior to significant morbidity. [4] Electrophysiological studies have shown the relation between glycated hemoglobin and the presence and also the severity of neuropathy. [5]

The aim of this study is to evaluate four standard simple screening tests (10-g Semmes-Weinstein monofilament examination {SWME}, vibration sensation by a128 Hz tuning fork, ankle reflex and superficial pain test) for detection of neuropathy using the NCSs as the standard criterion in diabetic patients.

Patient and Methods

Our study included 120 diabetic patients between March 2010 to July 2011, history taking of duration of diabetes, associated diseases, presence or absence of neuropathy (e.g. foot pain, tingling, numbness, imbalance, weakness and upper limb symptoms) and its duration if present, and they were examined as follows:

1. Exclusion of other causes of neuropathy (e.g. familial, nutritional, uremic, and alcoholic) by comprehensive examination medically and neurologically.
2. Standardized NCSs (bilateral) including motor (tibial, peroneal, median, and ulnar) and sensory (sural, median, and ulnar) nerves –performed by a blinded technicians to the status of the patient.
3. A10-g SWME (Fig. 1) superficial pain and vibration sense by a 128 Hz tuning fork (Fig. 2a,b) and ankle reflex, all were performed by a third examiner who is blinded to the history, physical examination and the results of NCSs.

Figure 1 10 gram sensory monofilament.

Figure 2a and 2b  128 hz tuning fork.

All data were entered on standardized forms, subjects identification was by number, date of birth, and initials.

Sensory testing methods

The patient was given a reference sensation by application of the stimulus to the sternum and then asked the nature of the sensation perceived. When the nature of the sensation was perceived accurately on the sternum, the patient was asked, with eyes closed, to describe the sensations experienced sequentially at the sites described below:

The SWME was conducted using a 10-g monofilament applied to a no callused site on the dorsum of the first toe just proximal to the nail bed. It was repeated four times on both feet in an arrhythmic manner. The SWME threshold was defined as the total number of times the application of 10-g monofilament was not perceived by the patient, and it varied from 0 to 8.

Vibration testing by a 128-Hz tuning fork applied to the bony prominence bilaterally situated at the dorsum of the first toe just proximal to the nail bed. The patient was asked to report the time at which vibration diminished beyond perception. The tuning fork was then applied to the dorsal aspect of the distal phalanx of the examiner’s thumb. The time (in seconds) at which vibration sensation diminished beyond the examiner’s perception was then recorded on a standardized form. The values from both sides were added to provide a single score for statistical analyses. The vibration test threshold was defined as the total number of times the application of the vibrating tuning fork and the dampening of vibration was not felt, with scores varying between 0 and 8.

Superficial pain sensation was conducted using a sterile NeurotipTM (Owen Mumford) applied four times to the two sites described in SWME. The superficial pain threshold was defined as the total number of times the application of the pain sensation was not perceived, with scores varying from 0 to 8. Ankle reflex was assessed with a tendon hammer and was recorded as either present or absent.

Criterion standard

Standardized techniques for NCSs were applied with temperature control and fixed distances. Measurements of latencies, distances, and amplitudes were assessed in a standard fashion using onset latencies and baseline to peak amplitudes. Initial positive peak (if present) to negative peak measurements were conducted for sensory responses. F waves were generated for all motor nerves, and minimal, reproducible latencies were measured. Conduction velocities were calculated for motor and sensory nerves.

All conduction velocity and distal amplitude values for the NCSs were given a score of 0 for normal and 1 for abnormal. The mean reference values+-2SD were taken as the normal range. The maximum NCS score if all parameters were abnormal was 28 points (16 motor and 12 sensory).The total NCS score was defined as the sum of the number of abnormal values.

Statistical analyses

The data were analyzed and we used the X2 test to detect the difference of results across the four tests compared to NCSs, P<0.01 was considered statistically significant. By constructing Receiver operating characteristic curve, sensitivity, specificity, positive and negative predictive values were calculated for the various tests using NCS as the gold standard definition of neuropathy.


The study included 120 diabetic patients .The mean age was 52.2±4.8 (range 22-85years), 59 males (49.2%), 61 females (50.8%). In the study all patients had type2diabetes, the mean duration of diabetes was 8.21±7.81 years and mean FPG 202.15±50.44 mg/dl, 80.2% were receiving oral hypoglycemic drugs, 19.8% were receiving insulin .Foot care practices were followed by 80 (66.6%) patients of the study population by optimization of the glycemic control, cessation of smoking, prescription of adequate proper fit foot wear with wide deep box and debridement of calluses with follow up at 6 months and 12 months.

Evaluation of neuropathy by nerve conduction study (NCSs) showed peripheral neuropathy in 75 patients (62.5%), using other testing modalities neuropathy was found in 56 (46.6%) patients with monofilament, in 45 (37.5%) with superficial pain test, in 57 (47.5%) with vibration test and in 56 (46.6 %) with ankle reflex. Table 1 presents the sensitivity, specificity, PPV, NPV and P-value of each diagnostic test compared with NCSs which was taken as the gold standard.

Table 1  Sensitivity, specificity and P-value of the four tests.  PPV (positive predictive value), NPV (negative predictive value).


In this study we used NCS as a standard criterion for the diagnosis of peripheral neuropathy. Since peripheral neuropathy is a main element in causing of both foot ulceration and amputation so selection of rapid, simple and accurate testing method for diagnosis of peripheral neuropathy in diabetic patients is so important and apart from NCS we select monofilament, superficial pain, tuning fork and ankle reflex for evaluation of peripheral neuropathy.

The most frequently used modality for peripheral neuropathy detection is the nylon Semmes-Weinstein monofilament. [7] Inability to perceive 10 g of force 5.07 monofilament applies is associated with clinically significant large-fiber neuropathy. In our study monofilament showed a sensitivity 57% and a specificity 91% compared to other studies with 95%sensitivity and 82% specificity, [8,9] other studies showed sensitivity of 77% and specificity 96% [6], also another study showed senility 66% and 34% specificity. [10]

The 128 Hz tuning fork in our study showed sensitivity of 56% and specificity of 90% compared to other study sensitivity and specificity was 53% and 99% respectively. The superficial pain test in our study showed sensitivity and specificity of 62% and 36% respectively 59% and 97% respectively.[6] The ankle reflex in our study showed sensitivity and specificity of 57% and 41% respectively compared to other studies showed sensitivity and specificity of 75% and 89% respectively. [11]


In our study we found that the simple screening tests (10g SWME, vibrating test, superficial pain test and ankle reflex) can be used confidently for annual screening of diabetic neuropathy in diabetic patients.


1. Britland ST, Young RJ, Sharma AK, Clarke BF. Association of painful and painless diabetic polyneuropathy with different patterns of nerve fiber degeneration and regeneration. Diabetes 1990 39: 898-908.
2. Ochoa J. Positive sensory symptoms in neuropathy: mechanisms and aspects of treatment. In Peripheral Nerve Disorders, 2nd ed. Asbury A, Thomas P (Eds) Oxford, UK, Butterworth-Heinemann, 1995, pp 44-58.
3. Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation: basis for prevention. Diabetes Care 1990 13: 513-521.
4. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Eng J Med 1993 329: 977-986.
5. Tkac I, Bril V. Glycemic control is related to the electrophysiologic severity of diabetic peripheral sensorimotor polyneuropathy. Diabetes Care 1998 21: 1749-1752.
6. Perkins BA, Olaleye D, Zinman B, Bril V. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care 2001 24: 250-256.
7. Armstrong DG. The 10-g monofilament: the diagnostic divining rod for the diabetic foot? Diabetes Care 2000 23: 984-988.
8. Armstrong DG, Lavery LA, Vela SA, Quebedeaux TL, Fleischli JG. Choosing a practical screening instrument to identify patients at risk for diabetic foot ulceration. Arch Intern Med 1998 158: 289-292.
9. de Sonnaville JJ, Colly JLP, Wijkel D, Heine RJ. The prevalence and determinants of foot ulceration in type II diabetic patients in a primary health care setting. Diabetes Res Clin Pract 1997 35: 149-156.
10. Boyko EJ, Ahroni JH, Stensel V, Forsberg RC, Davignon DR, Smith DG. A prospective study of risk factors for diabetic foot ulcer. The Seattle Diabetic Foot Study. Diabetes Care 1999 22: 1036-1042.
11. Tre GS, Lisbô HR, Syllo R, Canan LH, Gros JL. Prevalence and characteristics of diabetic polyneuropathy in Passo Fundo, South of Brazil. Arq Bras [Endocrinol] Metabol 2007 51: 987-992.

Address correspondence to: Ghada Morshed Ahmed Morshed, Galal El Deen El Seuty, El Manial, Cairo, Egypt. E-mail: ghadamorshed@yahoo.com. Tel: 0125870476

1,2,3  Departments of Surgery1, Internal Medicine2 and Neurology3. Faculty of Medicine, Fayoum University, Cairo, Egypt.

© The Foot and Ankle Online Journal, 2011