Orthopedics

Feature Article 

A Pulsed Electrical Joint Stimulator for the Treatment of Osteoarthritis of the Hand and Wrist

Peter A. Holt, MD; Tuna Ozyurekoglu, MD; Shaili Deveshwar, MD; Edmund J. Maclaughlin, MD; Anton Khlopas, MD; Michael A. Mont, MD; Shirley W. Pang, MD; Jack S. Tuber, DO; Joy Schechtman, DO; Thomas M. Zizic, MD

Abstract

The hand is commonly affected by osteoarthritis (OA). The development and progression of OA are believed to involve inflammation, even in the early stages of the disease. Inflammatory and proinflammatory cytokines have also been shown to be elevated in the flexor tenosynovium of idiopathic carpal tunnel syndrome (CTS). A large percentage of patients with hand OA also have a concomitant CTS. This study evaluated the results of a pulsed electrical joint stimulator in patients who had hand OA with or without CTS. Pain, tenderness, and swelling; grip strength and pinch force; and Patient and Physician Global Assessment and Disabilities of the Arm, Shoulder and Hand (DASH) results were evaluated. The primary efficacy outcome was pain due to OA in the study hand in the past 48 hours. Secondary outcomes consisted of OA pain in the study thumb in the past 48 hours, grip strength, pinch force, and Patient and Physician Global Assessment and DASH results. All 7 outcome parameters improved in OA patients. On physical examination, individual finger and wrist joints had also improved regarding pain, swelling, and tenderness. In the subset of patients with CTS, CTS pain, paresthesia, weakness, and all CTS symptoms had significantly improved. Patient and Physician Global Assessment and DASH results and pinch force were also significantly improved. This pulsed electrical joint stimulator is effective in providing clinically relevant and statistically significant reductions in the signs and symptoms of OA of the hand and CTS. It could be a useful modality for the treatment of patients who have one of these conditions or both. [Orthopedics. 2018; 41(4):e550–e556.]

Abstract

The hand is commonly affected by osteoarthritis (OA). The development and progression of OA are believed to involve inflammation, even in the early stages of the disease. Inflammatory and proinflammatory cytokines have also been shown to be elevated in the flexor tenosynovium of idiopathic carpal tunnel syndrome (CTS). A large percentage of patients with hand OA also have a concomitant CTS. This study evaluated the results of a pulsed electrical joint stimulator in patients who had hand OA with or without CTS. Pain, tenderness, and swelling; grip strength and pinch force; and Patient and Physician Global Assessment and Disabilities of the Arm, Shoulder and Hand (DASH) results were evaluated. The primary efficacy outcome was pain due to OA in the study hand in the past 48 hours. Secondary outcomes consisted of OA pain in the study thumb in the past 48 hours, grip strength, pinch force, and Patient and Physician Global Assessment and DASH results. All 7 outcome parameters improved in OA patients. On physical examination, individual finger and wrist joints had also improved regarding pain, swelling, and tenderness. In the subset of patients with CTS, CTS pain, paresthesia, weakness, and all CTS symptoms had significantly improved. Patient and Physician Global Assessment and DASH results and pinch force were also significantly improved. This pulsed electrical joint stimulator is effective in providing clinically relevant and statistically significant reductions in the signs and symptoms of OA of the hand and CTS. It could be a useful modality for the treatment of patients who have one of these conditions or both. [Orthopedics. 2018; 41(4):e550–e556.]

The hand is commonly affected by osteoarthritis (OA), with the prevalence of symptomatic disease being 16% for women and 8% for men, and especially high in older adults, among subjects of the Framingham Study.1 Using the Framingham data on prevalence in relation to age and sex among individuals 26 years and older and the corresponding 2005 population estimates from the US Census Bureau, the National Arthritis Data Workgroup estimated that 9,267,000 adults have symptomatic knee OA and 13,054,000 adults have symptomatic hand OA.2 Elderly women are more likely to have hand involvement than men, with one study reporting a prevalence of approximately 38% in women older than 66 years and approximately 24.5% for men.3 The most frequently affected joints are the distal interphalangeal, proximal interphalangeal, thumb interphalangeal, and trapeziometacarpal.4

The development and progression of OA are believed to involve inflammation, even in the early stages of the disease.5 Epidemiological studies show a clear relationship between the progression of tibiofemoral cartilage damage and the presence of a reactive or inflammatory synovium.6,7 Interleukin-1ß, tumor necrosis factor, and interleukin-6 appear to be the main proinflammatory cytokines involved in the pathophysiology of OA.8 Specifically, interleukin-1ß is associated with cartilage destruction, and tumor necrosis factor is involved with activating the inflammatory cascade. In patients with OA, levels of both interleukin-1ß and tumor necrosis factor are elevated in the synovial fluid, synovial membrane, subchondral bone, and cartilage. These factors induce production of proinflammatory cytokines such as interleukin-6 and chemokines such as interleukin-8 and stimulate the production of several other inflammatory mediators such as inducible nitric oxide synthase, soluble phospholipase A2, cyclooxygenase-2, nitric oxide, and prostaglandin E2.

One method to potentially decrease inflammatory and proinflammatory cytokines is to use pulsed electrical joint stimulation.9,10 In a bovine in vitro articular cartilage study, an electric field induced an elevation in the production of collagen and proteoglycan with and without interleukin-1ß.9 Similarly, Hungerford et al11 noted an increase of proteoglycan and type II collagen in patients with OA of the knee treated with the BioniCare knee device (VQ OrthoCare, Irvine, California). Gómez-Ochoa et al10 performed an in vitro study of pulsed electrical stimulation on liquid medium cultures of fibroblast-like cells. They reported a significant decrease in proinflammatory cytokines interleukin-1ß and tumor necrosis factor-α when compared with a control group (47 vs 153 pg/mL; P<.05). Several other in vitro studies reported similar findings.12 In addition, there have been several reports of the efficacy of the BioniCare device in vivo.11,13–16

Carpal tunnel syndrome (CTS) refers to the complex of symptoms and signs brought on by compression of the median nerve as it traverses the carpal tunnel. Patients commonly experience pain and paresthesia; weakness in the median nerve distribution is less common. Carpal tunnel syndrome is one of the most common peripheral nerve disorders, having a population prevalence of 5.8% in women and 0.6% in men.17 Of note, CTS and hearing loss have been found to account for more morbidity, measured by cases and working days lost, than any other illnesses among the US working population.18 Although the precise etiology of increased carpal tunnel pressure in idiopathic CTS is uncertain, experimental evidence suggests that anatomic compression, inflammation, or both are possible mechanisms. The role of overuse of the hand, particularly light repetitive work, in the causation of this disorder has not been definitely established; however, one study showed enlargement and T2 signal change on magnetic resonance imaging of the median nerve 8 hours after a 3-hour period of typing among healthy office workers.19 Inflammatory and proinflammatory cytokines have been shown to be elevated in the flexor tenosynovium of idiopathic CTS.20–22 Furthermore, the prevalence of CTS in patients who have hand OA has been reported to be as high as 39%.23

Clinical trials examining the efficacy of therapeutic approaches to OA of the hand and CTS are limited.24–26 Therefore, evidence regarding the management of hand OA has been largely derived from the knowledge obtained by treatment of OA in other joints.27 Interest in using the BioniCare pulsed electrical joint stimulator for OA of the hand and CTS is the result of the efficacy of this device in knee OA.11,13–16 Because a large percentage of patients who have hand OA also have a concomitant CTS, the purpose of this study was to evaluate the results of this specific pulsed electrical stimulator in a cohort of patients with hand OA and to perform a subgroup analysis of those who had both OA and CTS. Specifically, the authors assessed (1) pain, tenderness, and swelling; (2) grip strength and pinch force; and (3) Patient and Physician Global Assessment and Disabilities of the Arm, Shoulder and Hand (DASH) results.

Materials and Methods

Patient Selection

A total of 141 patients were prospectively enrolled in the study. A total of 125 patients with OA of the hand completed the 4-month follow-up. Of these patients, 33 had concomitant OA and CTS. There were 99 women and 26 men (mean age, 61 years; range, 35–89 years). Sixteen (11%) patients were lost to follow-up. Eleven (8%) patients stopped participating because local rash or discomfort prevented them from using the device for at least 6 hours a day. Three (2%) patients did not complete the study because of perceived lack of efficacy. Two patients were lost to follow-up.

This was a 4-month, multicenter, prospective open study. Institutional review board approval was obtained prior to commencement of the study. Patients 18 years or older who had a clinical diagnosis of OA of the hand for at least 3 months prior to study entry were included. Diagnosis of OA of the hand was by clinical examination and involved hand pain, aching, or stiffness and 3 or 4 of the following: hard tissue enlargement involving at least 2 of 10 selected joints, swelling of fewer than 3 metacarpophalangeal joints, hard tissue enlargement of at least 2 distal interphalangeal joints, and deformity of at least 1 of 10 selected joints.28 Additional inclusion criteria were a score of 3 or greater on a 10-point Likert scale for “pain in the last 48 hours” in the treated hand; analgesics and nonsteroidal anti-inflammatory drugs stable for 30 days prior to entry; and willingness to wear the investigational device for at least 6 hours per day. The following were excluded from this study: women who were pregnant, breast-feeding, or planning to become pregnant; patients with infectious arthritis, including, but not limited to, tuberculosis, post-Lyme disease, and so on; patients with infections in the treated hand in the previous 6 months; patients with pacemakers or implanted devices; patients with the diagnosis of gout, recurrent, inflammatory episodes of pseudogout, malignancy, inflammatory arthritis (eg, rheumatoid arthritis), psoriatic arthritis, Reiter's syndrome, ankylosing spondylitis, or collagen vascular diseases; patients with a history of malignancy within the past 3 years; patients with a history of drug or alcohol abuse within the past 2 years; patients intellectually or psychologically unable to complete the patient questionnaires; patients involved in litigation or receiving workers' compensation; patients who participated in any investigational study within the previous month; and patients who had surgery in the treated/study hand in the previous 6 months. When both hands were affected, the more symptomatic hand was designated as the index hand to be followed based on visual analog scale pain score. In the subset of patients with CTS, the diagnosis was made on clinical examination with pain or paresthesia in the distribution of the median nerve, for at least 3 months, and a positive result for Tinel's sign and/or Phalen's test. Exclusion criteria were the same as those for the full OA of the hand and wrist group. An additional inclusion criterion was the requirement of no other discernible cause for the CTS. Inflammatory diseases such as rheumatoid arthritis were identified by review of patient history, and these patients were excluded. Patients did not participate in physical or occupational therapy or have any other operative or nonoperative treatments for wrist or thumb arthritis during the study.

The BioniCare Hand System (VQ OrthoCare) is a portable, battery-operated pulsed electrical stimulation device that delivers a subsensory signal through skin electrodes. It is capable of delivering 0 to 12 V at a frequency of 100 Hz. Patients are instructed to adjust the voltage to deliver a signal just below what is perceptible. The BioniCare Hand System delivers the signal through a compressive, conductive glove that is worn around the wrist and hand. It has adhesive fingertip conductors and a dispersive electrode on the palmar side of the wrist (Figure). The BioniCare device can be used while awake or sleeping. Patients are instructed to use it for at least 6 hours per day. It contains a time-tracking device to monitor compliance.

The BioniCare Hand System (VQ OrthoCare, Irvine, California).

Figure:

The BioniCare Hand System (VQ OrthoCare, Irvine, California).

Patient Outcomes

The primary efficacy outcome was pain in the study hand in the previous 48 hours. Secondary outcomes consisted of pain in the study thumb in the previous 48 hours, grip strength, pinch force, and Patient and Physician Global Assessment and DASH results. The physicians performed a physical examination of all distal interphalangeal, proximal interphalangeal, and metacarpophalangeal joints as well as the carpal, metacarpal, and wrist joints of the study hand. Parameters evaluated were pain, tenderness, and swelling of each individual joint at baseline and at 4, 8, and 16 weeks of treatment with the BioniCare Hand System. In the subgroup analysis of patients who had concomitant OA and CTS, additional outcome variables included paresthesia, weakness, and any other CTS-related symptoms.

Grip and pinch strength are objective indications of function if accurately measured. The JAMAR Hand Evaluation Kit (Performance Health, Warrenville, Illinois), which includes a squeeze (grip) dynamometer and a pinch dynamometer, was used to obtain the measurements. Grip and pinch were determined by taking the average of 3 successive efforts with patients in a seated position.

Outcomes used in the treatment of hand disorders are difficult to assess because the major areas of interest are improvements in quality of life and function, which are difficult to quantify. Therefore, the DASH survey was jointly developed by the Institute for Work and Health and the American Academy of Orthopaedic Surgeons.29 The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in individuals with any of several musculoskeletal disorders of the upper limb. It is a single, reliable instrument that can be used to assess any or all joints in the upper extremity.

Data Analysis

SAS version 9.1.3 software (SAS Institute Inc, Cary, North Carolina) was used to compare preoperative with postoperative patient parameters. Univariate screening of associations between covariates and outcomes was done with simple statistical methods and tests, chi-square test, and log-rank test. Selected covariates were examined in the Cox model. Patients' baseline values served as controls for posttreatment values. Differences between baseline and final visit scores were compared using paired samples t tests. A multivariate analysis examined the effects of age, sex, and number of hours of device use on efficacy. Efficacy was expressed for each variable as the effect size. Effect sizes were previously defined by a 2003 European League Against Rheumatism task force as small (0.2 to 0.5), moderate (0.5 to 1.0), and large (>1.0).30 By protocol, an interim analysis was performed after 2 months of treatment with the device and a final analysis was completed after 4 months of treatment.

Results

Pain, Tenderness, and Swelling

For the 125 patients who completed the study, after 4 weeks of treatment, OA pain had an effect size of 1.0 (large) in the study hand and 0.7 (moderate) in the study thumb (Table 1). All outcomes were statistically significant. After 8 weeks of treatment, OA pain was 0.4 in the study hand and 0.7 in the study thumb. After 4 months of treatment, the effect size for OA pain was 1.0 in the study hand and 0.7 in the study thumb. On examination, pain, swelling, and tenderness were significantly improved at all of the distal interphalangeal joints, with effect sizes ranging from 0.2 to 0.4. Similarly, pain, swelling, and tenderness were significantly improved for all 5 proximal interphalangeal joints, with effect sizes ranging from 0.2 to 0.6. Except for the second and fifth metacarpophalangeal joints, pain, swelling, and tenderness were significantly improved in the metacarpophalangeal joints, with effect sizes ranging from 0.2 to 0.5. Improvement was particularly noticeable at the first metacarpophalangeal joint, with effect sizes of 0.4 for pain and 0.5 for tenderness of that joint. The carpometacarpal joint had significant improvement in pain (effect size of 0.6), swelling (effect size of 0.4), and tenderness (effect size of 0.6). There was mild improvement in tenderness and swelling of the wrist, with an effect size of 0.2 for each; however, the effect size was only 0.1 for pain. In a CTS subgroup analysis, at 4 weeks, all measured outcomes had improved, with effect sizes of 0.5 or greater (Table 2). At 8 weeks, pain, paresthesia, weakness, and all CTS symptoms had improved, with effect sizes of 0.6 or greater (Table 3). At 4 months, the effect sizes were 0.7 for CTS pain, 0.6 for paresthesias due to CTS, and 0.6 for weakness due to CTS.

Overall Patient Cohort Outcomes at 4 Weeks

Table 1:

Overall Patient Cohort Outcomes at 4 Weeks

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 4 Weeks

Table 2:

Effect Sizes of the BioniCare Hand System for Carpal Tunnel Syndrome at 4 Weeks

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 8 Weeks

Table 3:

Effect Sizes of the BioniCare Hand System for Carpal Tunnel Syndrome at 8 Weeks

Grip Strength and Pinch Force

At 8 weeks, grip strength had an effect size of 0.3 and pinch force had an effect size of 0.3 (Table 4). At 4 months, the effect size was 0.3 for pinch force and 0.3 for grip strength. In the CTS subgroup, at 8 weeks, the pinch force and the grip strength had improved, with small effect sizes of 0.2 and 0.3, respectively. At 4 months, the effect sizes were 0.1 for grip strength and 0.2 for pinch force.

Overall Patient Cohort Outcomes at 8 Weeks

Table 4:

Overall Patient Cohort Outcomes at 8 Weeks

Global Assessment and DASH

At 4 weeks, the Patient Global Assessment had an effect size of 0.9 and DASH had an effect size of 0.3 for OA of the study hand. All outcomes were statistically significant. At 8 weeks, the Patient Global Assessment had an effect size of 1.0 and DASH had an effect size of 0.5 for OA of the study hand. At 4 months, the Patient Global Assessment had an effect size of 1.0 and DASH had an effect size of 0.5 for OA of the study hand. At 8 weeks, the Physician Global Assessment had an effect size of 1.0 for OA of the study hand. Again, as with the 4-week evaluation, all outcomes were statistically significant. At 4 months, the Physician Global Assessment had an effect size of 1.3 (Table 5). In the CTS subcohort, DASH had an effect size of 0.6 and the Physician Global Assessment had an effect size of 1.5 (Table 6).

Overall Patient Cohort Outcomes at 4 Months

Table 5:

Overall Patient Cohort Outcomes at 4 Months

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 4 Months

Table 6:

Effect Sizes of the BioniCare Hand System for Carpal Tunnel Syndrome at 4 Months

Discussion

Synovial fluid inflammatory and proinflammatory cytokines have been shown to be elevated in hand OA. A pulsed electrical joint stimulator has been proposed to decrease joint inflammatory molecules. The purpose of this study was to evaluate the efficacy of the BioniCare Hand System for hand OA. Large effect sizes were seen for OA pain in the study hand, Patient Global Assessment of OA, and Physician Global Assessment of OA in the study hand. Medium effect sizes were seen for OA pain in the study thumb in the past 48 hours (0.8) and for DASH (0.5). Smaller but still significant effect sizes were seen for the objective measurements of hand grip strength (0.3) and pinch force (0.3). In addition, medium effect sizes were seen for all parameters except grip strength (0.3) and pinch force (0.2), which had smaller but still significant effect sizes.

The BioniCare Hand System has been examined extensively in the past 20 years with 5 studies involving 104 clinical settings and 907 patients. Two short-term, double-blind, randomized, multicenter, clinical trials comparing this device with a placebo provided level I evidence for its effectiveness.13,14 Zizic et al13 performed a prospective, multicenter study of 78 patients with knee OA who were randomized to receive either an active or a placebo device. Those treated with an active device had significantly greater improvements in pain (29% vs 10%; P=.0365), function (27% vs 8%; P=.0183), and physician global assessment (33% vs 12%; P=.0191).13 In a similar study, Garland et al14 stratified 58 patients with knee OA into 3 months of pulsed electrical stimulation or an inactive device worn for 6 to 14 hours per day. They reported 51% greater improvement in patient global assessment (P=.03), 31% greater improvement in pain (P=.04), and 20% greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index scores (P=.01) for the pulsed electrical stimulation group compared with the placebo cohort.

Three long-term clinical studies were then conducted to determine changes in disease state and the safety of this device, reporting statistically significant clinical effectiveness.4–29,31,32 In a multicenter study performed by Mont et al,15 157 patients with knee OA were treated with a pulsed electric stimulation device. More patients in this cohort deferred total knee arthroplasty at 1, 2, 3, and 4 years after treatment initiation when compared with an historical matching cohort (83% vs 67%, 75% vs 51%, 65% vs 46%, and 60% vs 35%, respectively; P=.0011). In addition, these patients had significantly greater improvements in pain (40%), function (38%), and physician global evaluation (41%) when compared with the control group. Similar findings were reported by other studies (Table 7).16 In addition, Hungerford et al11 reported a synergistic effect of a pulsed electric field when used in combination with an unloading brace in knee OA.

Improvement of Outcomes in the Pulsed Electrical Stimulation Group When Compared With the Matching Cohort

Table 7:

Improvement of Outcomes in the Pulsed Electrical Stimulation Group When Compared With the Matching Cohort

Electrical joint stimulation has also been shown to improve the symptoms of patients who have CTS. Oskouei et al31 performed a prospective study of 20 patients (32 hands) who received routine physiotherapy and did or did not receive electrical stimulation for 4 weeks. They reported significantly greater improvement in the median nerve tension test (69% vs 23%; P<.05) and functional status scale (31% vs 6%; P<.05) for the transcutaneous electrical stimulation group compared with the control cohort. In a prospective study of 63 patients who had CTS, Koca et al32 randomized patients into splint (22 patients), electrical stimulation (20 patients), and interferential current (21 patients) cohorts. The interferential current cohort had significantly larger improvements in pain (P<.001), median nerve motor distal latency (P=.047), and sensory nerve conduction velocity (P=.010).

This study had several limitations. There was no matched control group, as this was a case series study with the purpose of evaluating the safety and efficacy of a joint stimulator device in the treatment of wrist OA and CTS. In addition, medication use during the study was not monitored. However, rarely do objective functional test results improve after surgery for hand OA. In a prospective outcomes study of metacarpophalangeal joint arthroplasty, it was found that pain did decrease significantly 6 months and 1 year postoperatively (P<.01). However, the results of functional tests such as of grip and pinch strength improved only minimally 1 year postoperatively.33 Other studies also have found that when comparing postoperative values with preoperative values, there usually is no significant improvement in objective measures such as pinch force or grip strength.34,35

Conclusion

In OA patients, all 7 outcome parameters, including the more objective measures such as grip strength, pinch force, DASH, and the Physician Global Assessment, had improved. Physical examination of the individual finger and wrist joints also revealed improvement regarding pain, swelling, and tenderness. In addition, CTS symptoms improved, having large effect sizes. The pulsed electrical joint stimulator was effective in providing clinically relevant and statistically significant reductions in the signs and symptoms of OA of the hand and CTS. This could be a useful modality for the treatment of patients who have OA, CTS, or both.

References

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Overall Patient Cohort Outcomes at 4 Weeks

MeasureMean±SD, pointsEffect Size

BaselineWeek 4
Osteoarthritis pain—hand5.1±1.33.6±2.01.0
Osteoarthritis pain—thumb4.6±1.93.2±2.10.7
Patient Global Assessment5.3±1.53.7±2.00.9
Disabilities of the Arm, Shoulder and Hand score40.2±17.234.4±18.30.3

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 4 Weeks

MeasureMean±SD, pointsEffect Size

Week 0Week 4
Carpal tunnel syndrome pain past4.4±1.72.9±2.40.7
Carpal tunnel syndrome paresthesia4.0±2.12.7±2.20.6
Weakness due to carpal tunnel syndrome4.5±1.93.4±2.10.5
All carpal tunnel syndrome symptoms4.7±1.73.2±1.80.9
Disabilities of the Arm, Shoulder and Hand score49.3±18.138.4±19.90.6

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 8 Weeks

MeasureMean±SD, pointsEffect Size

Week 0Week 8
Carpal tunnel syndrome pain past4.4±1.83.0±2.30.6
Carpal tunnel syndrome paresthesia4.0±2.12.5±2.30.6
Weakness due to carpal tunnel syndrome4.6±1.93.2±2.10.6
All carpal tunnel syndrome symptoms4.7±1.73.3±2.10.7
Disabilities of the Arm, Shoulder and Hand score50.8±18.236.5±18.90.7
Pinch force18.7±9.220.0±9.50.2
Grip strength5.2±2.76.1±2.70.3
Physician Global Assessment5.8±1.43.8±2.11.0

Overall Patient Cohort Outcomes at 8 Weeks

MeasureMean±SD, pointsEffect Size

BaselineWeek 8
Osteoarthritis pain—hand5.2±1.43.8±5.60.4
Osteoarthritis pain—thumb4.5±1.93.2±2.20.7
Patient Global Assessment5.3±1.53.5±2.11.0
Disabilities of the Arm, Shoulder and Hand score40.7±17.832.1±17.50.5
Pinch force18.7±8.921.1±8.50.3
Grip strength4.7±2.55.5±2.70.3

Overall Patient Cohort Outcomes at 4 Months

MeasureMean±SD, pointsEffect Size

BaselineMonth 4
Osteoarthritis pain—hand5.2±1.43.3±2.41.0
Osteoarthritis pain—thumb4.6±1.93.0±2.50.7
Patient Global Assessment5.4±1.43.4±2.41.0
Disabilities of the Arm, Shoulder and Hand score41.3±17.732.6±19.70.5
Pinch force19.1±8.421.7±9.30.3
Grip strength4.9±2.55.7±2.70.3
Physician Global Assessment5.4±1.43.2±2.01.3

Effect Sizes of the BioniCare Hand Systema for Carpal Tunnel Syndrome at 4 Months

MeasureMean±SD, pointsEffect Size

Week 0Month 4
Carpal tunnel syndrome pain past4.4±1.83.0±2.30.7
Carpal tunnel syndrome paresthesia4.0±2.12.8±2.30.6
Weakness due to carpal tunnel syndrome4.6±1.93.5±2.20.6
All carpal tunnel syndrome symptoms4.7±1.73.4±2.30.6
Disabilities of the Arm, Shoulder and Hand score50.8±18.237.8±21.90.6
Pinch force18.7±9.220.7±9.40.2
Grip strength5.2±2.75.3±2.50.1
Physician Global Assessment5.8±1.43.3±2.01.5

Improvement of Outcomes in the Pulsed Electrical Stimulation Group When Compared With the Matching Cohort

Study (Year)PainFunctionGlobal Assessment
Zizic et al13 (1995)29%27%33%
Mont et al15 (2006)40%38%41%
Farr et al16 (2006)N/AN/A59%
Garland et al14 (2007)31%20%51%
Authors

The authors are from The Johns Hopkins University School of Medicine (PAH, TMZ), Baltimore, and the University of Maryland Shore Medical Center (EJM), Cambridge, Maryland; the Christine M. Kleinert Institute for Hand and Microsurgery (TO), Louisville, Kentucky; the Sports Medicine and Orthopedic Center (SD), Greensboro, North Carolina; the Department of Orthopaedic Surgery (AK, MAM), Cleveland Clinic, Cleveland, Ohio; St. Jude Heritage Medical Group (SWP), Fullerton, California; and the SunValley Arthritis Center (JST, JS), Peoria, Arizona.

Drs Khlopas and Mont are previous Blue Ribbon Article Award recipients (Orthopedics, March/April 2018).

Drs Holt, Ozyurekoglu, Deveshwar, Maclaughlin, Khlopas, Mont, Pang, Tuber, and Schechtman have no relevant financial relationships to disclose. Dr Zizic is a paid consultant for and receives royalties from VQ OrthoCare.

Correspondence should be addressed to: Michael A. Mont, MD, Department of Orthopaedic Surgery, Cleveland Clinic, 9500 Euclid Ave, A40, Cleveland, OH 44195 ( montm@ccf.org).

Received: October 22, 2017
Accepted: March 01, 2018
Posted Online: May 30, 2018

10.3928/01477447-20180524-01

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