Archives of Physical Medicine and Rehabilitation
Volume 88, Issue 11 , Pages 1429-1435, November 2007

Efficacy of a Fabricated Customized Splint and Tendon and Nerve Gliding Exercises for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial

    MAJ
  • Teresa L. Brininger, SP, USA

      Affiliations

    • Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA
    • Corresponding Author InformationReprint requests to MAJ Teresa L. Brininger, PhD, OTR, CHT, United States Army Research Institute of Environmental Medicine, 15 Kansas St, Bldg 42, Natick, MA 01760
    • ,
  • Joan C. Rogers, PhD

      Affiliations

    • Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA
    • ,
  • Margo B. Holm, PhD

      Affiliations

    • Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA
    • ,
  • Nancy A. Baker, ScD

      Affiliations

    • Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA
    • ,
  • Zong-Ming Li, PhD

      Affiliations

    • Hand Research Laboratory, University of Pittsburgh Medical Center, Pittsburgh, PA
    • ,
  • Robert J. Goitz, MD

      Affiliations

    • Department of Orthopedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.

Article Outline

Abstract 

Brininger TL, Rogers JC, Holm MB, Baker NA, Li Z-M, Goitz RJ. Efficacy of a fabricated customized splint and tendon and nerve gliding exercises for the treatment of carpal tunnel syndrome: a randomized controlled trial.

Objective

To compare the effects of a neutral wrist and metacarpophalangeal (MCP) splint with a wrist cock-up splint, with and without exercises, for the treatment of carpal tunnel syndrome (CTS).

Design

A 2×2×3 randomized factorial design with 3 main factors: splint (neutral wrist and MCP and wrist cock-up), exercise (exercises, no exercise), and time (baseline, 4wk, 8wk).

Setting

Subjects were evaluated in an outpatient hand therapy clinic.

Participants

Sixty-one subjects with mild to moderate CTS; 51 subjects completed the study.

Interventions

There were 4 groups: the neutral wrist and MCP group and the neutral wrist and MCP-exercise group received fabricated customized splints that supported the wrist and MCP joints; the wrist cock-up group and the wrist cock-up-exercise group received wrist cock-up splints. The neutral wrist and MCP-exercise and wrist cock-up-exercise groups also received tendon and nerve gliding exercises and were instructed to perform exercises 3 times a day. All subjects were instructed to wear the assigned splint every night for 4 weeks.

Main Outcome Measures

We used the CTS Symptom Severity Scale (SSS) and the Functional Status Scale (FSS) to assess CTS symptoms and functional status.

Results

Analysis of variance showed a significant main effect for splint and time on the SSS (P<.001, P=.014) and FSS (P<.001, P=.029), respectively. There were no interaction effects.

Conclusions

Our results validate the use of wrist splints for the treatment of CTS, and suggest that a splint that supports the wrist and MCP joints in neutral may be more effective than a wrist cock-up splint.

Key Words: Carpal tunnel syndrome, Rehabilitation, Splints, Treatment outcome

 

THE MAJORITY OF PEOPLE who seek medical treatment for symptoms of carpal tunnel syndrome (CTS) do so to reduce their symptoms and improve their functional status. Currently, several conservative interventions are used to treat CTS. Evidence of the effectiveness of these interventions is lacking, however.

CTS is a compression neuropathy at the carpal tunnel in the wrist that results in sensory and motor impairments in the median nerve distribution of the hand. Symptoms of CTS are nocturnal pain, paresthesias, weakness, and, in severe cases, atrophy of the thenar muscles. CTS is a potentially disabling disorder and if left untreated, may cause permanent damage to the median nerve that results in loss of hand function.

CTS was first described in the medical literature in 18541 and now is among the most common clinically diagnosed upper-extremity neuropathies. It is prevalent in 3.7% of the United States population2 and its incidence is 276 per 100,000 people.3 CTS is more frequent in women than in men (15.6% and 11.3%, respectively),4 and is bilateral from 59% to 87% of patients.5, 6, 7 Surgery for the treatment of severe CTS is among the most common hand surgeries, exceeding 500,000 carpal tunnel releases a year, with their concomitant costs exceeding $2 billion annually.8 Safe, effective, and economic conservative interventions for the treatment of mild-to-moderate CTS are needed.

Conservative interventions, such as splinting, tendon and nerve gliding exercises, and ultrasound, are frequently prescribed for mild-to-moderate CTS.9, 10, 11 Once patients present with severe CTS—characterized by muscular atrophy and significant sensory loss—surgery becomes the treatment of choice.12 Splinting the wrist is the most common conservative intervention12, 13 and may be recommended in conjunction with tendon and nerve gliding exercises.14, 15

The rationale for splinting the wrist is supported by anatomic and clinical studies. Anatomic studies demonstrate that pressure in the carpal tunnel is at its lowest when the wrist is placed in a neutral position, and is at its highest when the wrist moves into flexion and extension.16, 17 Clinical studies9, 10 have validated the effectiveness of neutral wrist splinting, however, wrist position may not be the only consideration when splinting. When the fingers are actively flexed, specifically the metacarpophalangeal (MCP) joints, the lumbrical muscles migrate into the carpal tunnel and increase carpal tunnel pressure.18, 19, 20, 21, 22 This suggests that when splinting for CTS, the position of the MCP joints should be considered and splints should be designed to prevent the lumbrical muscles from migrating into the carpal tunnel. The only study23 that has evaluated the efficacy of finger positioning for treating CTS found a significant reduction in CTS symptoms and an improvement in functional status when patients wore a hand brace that supported the third and fourth digits in extension.

Splinting restricts movement and maintains the wrist and hand in the best anatomic position for minimizing carpal tunnel pressure; however, controlled active flexion and extension finger exercises, such as tendon gliding exercises, also reduce that pressure.24 In addition, they may provide sufficient movement between the median nerve and the flexor tendons to prevent adhesions.25 In turn, mobilizing the median nerve may increase blood flow to the nerve, which helps nerve regeneration, and ultimately improves nerve conduction.26

Regardless of the anatomic studies, clinical studies that have investigated the effectiveness of tendon and nerve gliding exercises lack the definitive evidence that would support or refute their use in the treatment of CTS.9, 10, 11 A study by Akalin et al14 that compared tendon and nerve gliding exercises with splinting found a significant improvement for lateral pinch after exercise, but not for reducing symptoms. Rozmaryn et al15 found that subjects who performed tendon and nerve gliding exercises had fewer surgeries than the subjects who did not perform the exercises. This was a retrospective study, however, and subjects did not follow a standard treatment protocol, thus making it difficult to determine whether the improvement resulted solely from the tendon and nerve gliding exercises, or from a combination of interventions.

Our purpose in this randomized controlled trial (RCT) was to compare the efficacy of a fabricated, customized splint that positions the wrist and the MCP joints in neutral (neutral wrist and MCP) with an off-the-shelf, wrist cock-up splint, with and without tendon and nerve gliding exercises, in the treatment of CTS. We studied 4 groups that received the following interventions: fabricated neutral wrist and MCP splint with no exercises (neutral wrist and MCP); fabricated neutral wrist and MCP splint with tendon and nerve gliding exercises (neutral wrist and MCP-exercise); off-the-shelf, wrist cock-up splint with no exercises (wrist cock-up), and off-the-shelf, wrist cock-up splint with tendon and nerve gliding exercises (wrist cock-up-exercise).

Our hypotheses were: (1) all treatments would reduce CTS symptoms and improve functional status over time; (2) the groups that received the fabricated neutral wrist and MCP splint would evince greater reduction in symptom severity and improvement in functional status than the groups that received the wrist cock-up splint (neutral wrist and MCP and neutral wrist and MCP-exercise versus wrist cock-up and wrist cock-up and exercise); and (3) the groups that performed the exercises would show greater reduction in symptom severity and improvement in functional status than the groups that did not perform exercises (neutral wrist and MCP-exercise and wrist cock-up-exercise vs neutral wrist and MCP and wrist cock-up).

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Methods 

Participants 

The trial included 61 subjects (14 men, 47 women) who were recruited from the University of Pittsburgh Medical Center’s Orthopedic Outpatient Hand Clinic between March 2004 and March 2005. To qualify for the study, subjects had to be at least 18 years of age, have a positive Tinel sign or Phalen maneuver, and have complaints of nocturnal numbness and tingling. Subjects were excluded if they had had a neuropathy other than CTS in the past year (symptoms of CTS might have been due to an underlying cause, eg, diabetes mellitus, or thyroid disease); were pregnant (CTS symptoms may resolve after delivery or termination of the pregnancy); had thenar atrophy (weakness or atrophy of the thenar muscles are an indication of severe CTS, and in most cases, surgical release is recommended); or had a steroid injection into the carpal canal in the past 3 months or a prior carpal tunnel release. Subjects were referred to the study by an orthopedic hand surgeon (RJG), who determined their eligibility. The University of Pittsburgh Institutional Review Board approved the study.

Sample Size 

The required sample size was calculated using the SPSS Power Analysisa program using a 2×2 factorial design accounting for splint and exercise. The criterion for significance (α) was set at .05. A priori power analysis suggested that a sample size of 40 (10 subjects per group) was required to minimize the type II error rate based on a large effect size (f =.47), and power set at .80 to yield a statistically significant result. The effect size of .47 was used in the analysis because that was the effect size of the CTS Symptom Severity Scale (SSS) (our primary outcome measure in this study) in a study by Akalin,14 which compared a CTS group that wore a neutral wrist splint with a second group that wore a neutral wrist splint and performed tendon and nerve gliding exercises. To compensate for withdrawals, we oversampled by 21 subjects, which resulted in a total of 61 subjects.

Study Design 

We used a randomized 2 (splint) by 2 (exercise) by 3 (time) factor design for the primary outcome measure and a 2 (splint) by 2 (exercise) by 2 (time) factor design for the secondary outcome measures. The independent variable, splint, consisted of 2 levels: a fabricated neutral wrist splint that included the MCP joints and an off-the-shelf wrist cock-up splint. The independent variable, exercise, consisted of 2 levels: tendon and nerve gliding exercises and no exercises. The independent variable, time, consisted of 3 levels for the primary outcome measure: baseline, 4-week post-test, and 8-week follow-up, and 2 levels for the secondary outcome measures of baseline and 4-week post-test.

Interventions 

There were 4 groups. Subjects in the neutral wrist and MCP and neutral wrist and MCP-exercise groups received a customized, fabricated wrist splint positioning the wrist in neutral (0°) and the MCP joints from 0° to 10° of flexion (fig 1). Subjects in the wrist cock-up and wrist cock-up-exercise groups received a prefabricated, off-the-shelf wrist cock-up splint that immobilized the wrist in 20° of extension (fig 2). Subjects who received the prefabricated splint were fitted with the appropriate size (extra small, small, medium, large) and the splint was shaped to provide the best comfortable fit. All subjects were told to notify the primary investigator (TLB) of any discomfort when wearing the splint. All groups were instructed to wear the splint during their regularly scheduled sleep time for 4 weeks. In addition, subjects in the neutral wrist and MCP-exercise and the wrist cock-up-exercise groups received visual and verbal instructions on tendon and nerve gliding exercises.27 Subjects were instructed to perform the exercises 3 to 5 times a day, with 10 repetitions in each position, and to hold each position for 5 seconds. Subjects showed their competency with the exercise program by verbally describing and visually demonstrating the exercises to the primary investigator. All groups received an educational brochure written by the hand clinic physicians that explained CTS signs, symptoms, and treatments. After 4 weeks, subjects were instructed to wear their splints and to perform exercises as needed to manage CTS symptoms.

Outcome Measures 

The primary outcome measure, the CTS SSS and Functional Status Scale (FSS),28 is a subjective questionnaire that evaluates symptom severity and functional status in subjects with CTS. It consists of 2 subscales: the 11-item SSS (eg, numbness, tingling, pain) and the 8-item FSS (eg, writing, buttoning). Response options range from 1 point (no symptoms or no difficulty performing activities) to 5 points (most severe pain or unable to perform activity). Subjects with bilateral CTS were instructed to answer the questions with regard to the hand that was being studied. Subscale scores are the mean of each subscale and range from 1 to 5; higher scores indicate greater impairment or disability. This measure is highly reproducible, internally consistent, valid, and responsive to clinical change.28

Objective secondary outcome measures were the Moberg Pick-up Test,29 grip strength, and pinch strength. The Moberg Pick-up Test is commonly used to evaluate functional sensibility. The test reflects fine motor performance and requires an ability to perceive constant touch and to use precision sensory pinch. Subjects are timed on how quickly they pick up an assortment of objects such as a coin, safety pin, and paper clip, and place them in a small box. We measured grip strength with a hand-held dynamometer,b which is a sensitive and repeatable testing instrument.30 Subjects were given 3 opportunities to exert maximum force; we recorded the mean of 3 successive trials. Pinch strength was measured with a reliable and accurate hand-held pinch meter.30,c Subjects had 1 opportunity to exert maximum force with 3 types of pinch: tip pinch, lateral pinch, and palmar pinch.

All subjects completed a demographic and CTS history questionnaire that included questions regarding age, sex, hand dominance, ethnicity, height, weight, and occupation. In addition, subjects who completed the study participated in an exit survey developed by the primary investigator that was designed to determine if they had received any additional interventions during the study, and to evaluate their level of satisfaction with the treatment provided.

Procedures 

The principal investigator collected baseline and 4-week data in the hand clinic; 8-week data (primary outcome measure and exit survey) were collected by mail. Random allocation was made after subjects gave their informed consent and baseline assessments were completed. Subjects were randomized into groups by selecting a sealed opaque envelope that contained a number corresponding to an intervention group. The primary investigator administered all interventions, including fabricating the customized splint and teaching the exercises.

Adherence to Protocol 

Adherence to the treatment protocol was tracked in a daily log that subjects returned to the principal investigator weekly. Subjects were instructed to record how often they wore the splint (all night, half the night, not at all) and how many sessions of the exercise program they performed during the day. At the end of each week, subjects were contacted by telephone and reminded to wear the splint and to continue to perform prescribed tendon and nerve gliding exercises. Adherence to the protocol was defined as wearing the assigned splint at night at least 80% of the time, and performing the tendon and nerve gliding exercises a minimum of 3 times a day 80% of the time.

Data Analysis 

Descriptive statistics were computed for subject demographics and baseline clinical characteristics. We used 1-way analysis of variance (ANOVA) tests to compare baseline characteristics for continuous variables, and the Kruskal-Wallis test to compare the categorical variables.

The effects of type of splint and exercise over time were analyzed with a 2×2×3 mixed-model ANOVA for the subjective measure subscales and a 2×2×2 mixed-model ANOVA for the objective measures. Data on the 51 subjects who completed the protocol were used in these analyses. In addition, we did an intention-to-treat (ITT) analysis on the 61 subjects who consented to participate in the study to preserve the effect of randomization, and to consider the practical impact of treatment.

The clinical significance was analyzed using partial η2, which we selected because it only considers the effect of interest and eliminates the influence of other factors, thus preventing more powerful variables from skewing the results.31 Descriptive statistics, inferential statistics, and effect sizes were calculated with SPSS (version 12.0)a for Windows.

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Results 

Sixty-one of 79 eligible patients enrolled in the study. Four subjects withdrew because: they had an injection or surgery (n=2), developed an illness (n=1), or moved out of the area (n=1); 6 subjects were lost to follow-up (fig 3). Thus, 51 subjects (10 men, 41 women) completed the study. Their mean age was 50 years (range, 21–86y) and 55% of the subjects reported bilateral CTS. All groups were similar in demographic and clinical characteristics at baseline (table 1).

Table 1. Subject Demographic and Clinical Characteristics
CharacteristicsNW/MCP-X (n=13)NW/MCP (n=14)WCU-X (n=13)WCU (n=11)P⁎
Demographic
Age (y)51.9±15.749.0±15.450.1±13.246.6±12.9.83
Sex .34
Male3142
Female101399
Hand dominance .11
Right81187
Left5354
Bilateral CTS6866.28
Race .71
White1313811
Black0120
Other 3
Employment status .60
Full-time6697
Part-time3322
Not working4522
Symptom duration .73
0–6mo3563
6–12mo2314
1–2y3221
>2y5443
Cause of CTS .82
Occupation5884
Other8657
Clinical
CTS SSS†2.5±0.52.4±0.82.9±0.92.8±0.8.31
CTS FSS†1.8±0.72.2±0.82.4±0.82.2±0.9.20
Moberg Pick-up Test (s)15.2±5.015.6±5.016.4±6.014.0±4.2.69
Grip strength‡ (lb)62.3±33.648.3±16.858.5±32.953.3±19.7.57
Tip pinch‡ (lb)11.4±5.59.9±3.312.0±5.59.0±2.9.35
Palmar pinch‡ (lb)14.8±5.913.2±4.713.9±5.412.9±3.3.79
Lateral pinch‡ (lb)16.2±5.715.7±4.716.5±7.514.7±3.8.87

NOTE. Values are mean ± standard deviations or n. To convert grip strength, tip pinch, palmar pinch, and lateral pinch scores, multiply by .45.

Abbreviations: NW, neutral wrist; WCU, wrist cock-up; X, exercise.

⁎Statistical significance (α) set at .05.

†Higher scores indicate greater impairment.

‡Higher scores indicate lesser impairment.

The results of the means and mixed-model ANOVAs produced a significant Mauchly test of sphericity for the dependent variables, indicating that the assumption of sphericity had been violated, thus, we used the Greenhouse-Geisser correction factor. There were no significant 2- or 3-way interaction effects with the other factors; however, both time (within groups) and splint (between groups) produced significant main effects.

The main effect of splint was significant for the primary subjective outcome measure subscales (CTS SSS, F1,47=6.45, P=.014; FSS, F1,47=5.10, P=.029). Overall, the neutral wrist and MCP splint group reported a greater reduction in symptoms (mean, 2.045) than the wrist cock-up splint group (mean, 2.508). Further analysis demonstrated that the neutral wrist and MCP splint had a medium effect on CTS symptoms (partial η2=.12) and functional status (partial η2=.10). The results of the satisfaction survey provided further evidence of the effectiveness of the neutral wrist and MCP splint; 38% of the subjects randomized to that group reported “no to occasional symptoms” after 8 weeks; in comparison, 17% of the subjects randomized to the wrist cock-up splint group reported this frequency of symptoms.

The main effect of time showed a significant improvement on the subjective primary outcome measure subscales (CTS SSS, F1.7,81.59=27.26, P<.001; FSS, F1.6,75.93=17.39, P<.001). Post hoc testing revealed differences for the pairwise comparison on the CTS SSS between baseline (mean, 2.65) and 4 weeks (mean, 2.08) and baseline (mean, 2.65) and 8 weeks (mean, 2.08); the FSS between baseline (mean, 2.15) and 4 weeks (mean, 1.77) and baseline (mean, 2.15) and 8 weeks (mean, 1.72). Over time, all groups, regardless of splint and exercise, had significantly decreased CTS symptoms and improved functional status and maintained that improvement for 8 weeks. In addition, the main effect of time was significant for the secondary objective outcome measures of tip pinch (F1,47=7.79, P=.008) and palmar pinch (F1,47=4.75, P=.034). All groups significantly improved tip pinch strength from baseline (mean, 4.75kg [10.56lb]) to 4 weeks (mean, 5.13kg [11.40lb]), and palmar pinch strength from baseline (mean, 6.17kg [13.70lb]) to 4 weeks (mean, 6.55kg [14.55lb]). There were no significant main effects for exercise on any of the outcome measures.

In addition to the on-protocol analysis, we conducted an ITT analysis using the mixed-model ANOVA. The results were similar to the on-protocol analyses, except the ITT analysis found a significant effect of time on grip strength (F1,57=4.41, P=.04).

Adherence to Protocol and Subject Satisfaction 

Overall, subjects adhered to the requirements for wearing the splint. According to self-reports, 88% of the subjects reported wearing their splint all night at least 80% of the time and the remaining subjects reported wearing it at least 50% of the time. In addition, 93% of the subjects who wore the neutral wrist and MCP splint, compared with 88% of subjects who wore the wrist cock-up splint, reported that it was comfortable and that they would continue to wear the splint as needed.

Adherence to the tendon and nerve gliding exercise program was also high; 81% of the subjects performed the exercises at least 80% of the time and the remaining subjects performed them at least 50% of the time. Two subjects who reported partial compliance reported that the exercises increased the pain in their wrists.

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Discussion 

Currently, several conservative interventions are used to treat CTS. Evidence on the effectiveness of these interventions is lacking, however. In this RCT, we used valid and reliable measures to evaluate the effectiveness of a nontraditional splint and tendon and nerve gliding exercises to treat mild-to-moderate CTS.

As expected, the study population’s sex and age were consistent with population-based studies of CTS prevalence.2, 4, 32 More women (77%) than men (23%) enrolled in the study and on average, the subjects were middle-aged. Furthermore, 56% of the subjects reported bilateral CTS, which is also consistent with the findings of other studies.5, 6, 7

The main finding of this RCT supported the hypothesis that all subjects would improve over time. Both splint groups, regardless of whether tendon and nerve gliding exercises were performed, improved over time. The wrist cock-up splint and the neutral wrist and MCP splint significantly reduced CTS symptoms and improved functional status over 4 weeks, and that improvement was sustained for an additional 4 weeks. These findings support other findings that wrist splinting significantly reduces CTS symptoms and improves functional status short term.33, 34 Furthermore, we found that all groups significantly improved in tip pinch and palmar pinch from baseline to the 4-week follow-up.

We also hypothesized that there would be a significant difference between the groups that received the neutral wrist and MCP splint compared with the groups that received the wrist cock-up splint because of the position of the lumbrical muscles. The neutral wrist and MCP splint positions the MCP joint in 0° to 10° of flexion and does not allow subjects to sleep with their wrist flexed and their hand in a fisted position, thus preventing the lumbrical muscles from entering the canal and preventing an increase in carpal tunnel pressure. Anatomic studies have reported that when the fingers are actively flexed, the lumbrical muscles migrate into the carpal tunnel and increase carpal tunnel pressure.18, 19 We found a significant difference between the fabricated customized neutral wrist and MCP splint group compared with the off-the-shelf wrist cock-up splint group. Further analysis indicated a medium treatment effect35 for the variable splint, which suggests that clinically, the fabricated neutral wrist and MCP splint may be more effective than the off-the-shelf wrist cock-up splint.

Of the many studies on splinting for CTS, we found only 123 that evaluated the effects of finger positioning on CTS symptoms and function. Manente et al23 reported that subjects who wore a hand brace had significantly reduced CTS symptoms and improved functional status. Manente did not consider the position of the wrist, however, and they compared the splint group with a control group that did not receive any treatment. Because there is evidence that immobilizing the wrist is an effective treatment for CTS33, 34 it is unclear if the hand brace is more efficacious than a traditional wrist splint. In this study, we evaluated the effects of wrist and finger positioning for the treatment of CTS and found that a splint immobilizing the wrist and fingers is more effective than the traditional wrist cock-up splint.

This study did not support our third hypothesis that there would be a significant difference in CTS symptom severity and functional status between the groups that received exercises compared with the groups that did not. These results differed from other studies that evaluated the effects of tendon and nerve gliding exercises.14, 15 Rozmaryn et al15 found that subjects who received tendon and nerve gliding exercises underwent surgery 28% less often than those who received traditional treatment. Theirs was a retrospective study that provides a lower level of evidence than an RCT, and the groups did not follow a standard treatment protocol. Akalin et al14 compared subjects who wore splints with subjects who wore splints and performed tendon and nerve gliding exercises. They reported that both groups improved, and there was a significant difference between the groups on lateral pinch strength. Adherence to the protocol was not reported, however, which made it difficult to determine if and how often subjects followed their prescribed exercise regime.

Study Limitations 

This study had several limitations. An orthopedic hand surgeon who practices in a large, academic medical center outpatient hand clinic referred the subjects. Thus, many subjects had sought treatment for their CTS elsewhere, and/or the cases seen by the hand surgeon were more severe. Approximately 41% of the subjects were treated previously with a splint or anti-inflammatory medications before being seen by the hand surgeon. Furthermore, 67% of the subjects who completed the study had symptoms of CTS for longer than 6 months, which may have minimized the effect of treatment. Splinting is most effective if prescribed within the first 3 months of symptoms onset.36

Another limitation was our inability to control for other potential confounding variables except through randomization. For example, other interventions such as anti-inflammatory medications and injections could not be withheld during the study period. Of the 51 subjects, 7.8% were taking anti-inflammatory medications and 17.6% received an injection after the 4-week period. Therefore, it is not clear whether the improvement resulted solely from the intervention or from the effect of medications or injections. Splinting, however, was reported by 62.7% of the subjects to be the most beneficial intervention for their CTS symptoms, compared with 2% who reported medication to be the most helpful, and 5.8% who reported injection to be the most helpful.

Another limitation was that the person (TLB) who administered the treatment and evaluated outcomes was not masked to subjects’ group assignments, and that may have biased the results. The person’s inclination to favor one intervention over another may have influenced the subject’s attitudes and feelings and thus affected the results of the outcome measures. For example, subjects may have wanted to please the principal investigator by giving favorable answers concerning the subjective outcome measures and by trying harder on the objective outcome measures.

The short-term follow-up was another limitation. This study administered subjective and objective measures at 4 weeks and subjective measures only at 8 weeks. Thus, recurrence rates and long-term results are unknown.

Despite its limitations, the study had its strengths: it was an RCT, the outcome measures are reliable and valid, and are commonly used in clinics.

Future Research 

In this study, the majority of subjects reported a history of CTS, and another medical provider had treated many of them before they enrolled in the study. Future research should focus on evaluating the effectiveness of the fabricated customized neutral wrist and MCP splints for patients newly diagnosed with CTS and in patients with CTS symptoms resulting from the lumbrical muscles migrating into the carpal tunnel. Furthermore, this study followed subjects for only 8 weeks. Future research should include a longer-term follow-up and more frequent evaluations to determine if this splint is more effective than traditional splints for the long-term treatment of CTS. Our results do not support the use of tendon and nerve gliding exercises in treating CTS, contrary to what others have reported.14, 15 Future studies, with larger sample sizes and a more strenuous adherence to the exercise arm of the protocol, need to be conducted to determine the effectiveness of these exercises in the treatment of CTS.

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Conclusions 

CTS is among the most commonly diagnosed upper-extremity neuropathies. Rising health care and indemnity costs are just a few of the many implications of CTS for modern society. Determining safe, effective, and economic conservative interventions for the treatment of mild-to-moderate CTS should be a priority. The purpose of this study was to compare the effects of a fabricated customized neutral wrist and MCP splint to a wrist cock-up splint, with and without tendon and nerve gliding exercises, for the treatment of mild-to-moderate CTS. Our results provide further evidence of the effectiveness of splinting, designed to target an underlying anatomic problem, for reducing symptoms and improving functional status in patients with mild-to-moderate CTS.

Supplier

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Acknowledgment 

The opinions or assertions contained herein are the private views of the author(s) and are not to be construed as official or as reflecting the views of the U.S. Army or the U.S. Department of Defense.

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  • a SPSS Inc, 233 S Wacker Dr, 11th Fl, Chicago, IL 60606.
  • b Jamar; Fabrication Enterprises Inc, PO Box 1500, White Plains, NY 10602.
  • c B&L Engineering, 3002 Dow Ave, Ste 416, Tustin, CA 92780.

 Supported by the School of Health and Rehabilitation Science Development Fund, School of Health and Rehabilitation Sciences, University of Pittsburgh, PA.

 No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated.

PII: S0003-9993(07)01337-8

doi:10.1016/j.apmr.2007.07.019

Archives of Physical Medicine and Rehabilitation
Volume 88, Issue 11 , Pages 1429-1435, November 2007

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