Beruflich Dokumente
Kultur Dokumente
ORIGINAL ARTICLE
CTS symptoms and an improvement in functional status after delivery or termination of the pregnancy); had thenar
when patients wore a hand brace that supported the third and atrophy (weakness or atrophy of the thenar muscles are an
fourth digits in extension. indication of severe CTS, and in most cases, surgical release is
Splinting restricts movement and maintains the wrist and recommended); or had a steroid injection into the carpal canal
hand in the best anatomic position for minimizing carpal tunnel in the past 3 months or a prior carpal tunnel release. Subjects
pressure; however, controlled active flexion and extension fin- were referred to the study by an orthopedic hand surgeon
ger exercises, such as tendon gliding exercises, also reduce that (RJG), who determined their eligibility. The University of
pressure.24 In addition, they may provide sufficient movement Pittsburgh Institutional Review Board approved the study.
between the median nerve and the flexor tendons to prevent
adhesions.25 In turn, mobilizing the median nerve may increase Sample Size
blood flow to the nerve, which helps nerve regeneration, and The required sample size was calculated using the SPSS
ultimately improves nerve conduction.26 Power Analysisa program using a 2⫻2 factorial design ac-
Regardless of the anatomic studies, clinical studies that have counting for splint and exercise. The criterion for significance
investigated the effectiveness of tendon and nerve gliding (␣) was set at .05. A priori power analysis suggested that a
exercises lack the definitive evidence that would support or sample size of 40 (10 subjects per group) was required to
refute their use in the treatment of CTS.9-11 A study by Akalin minimize the type II error rate based on a large effect size (f
et al14 that compared tendon and nerve gliding exercises with ⫽.47), and power set at .80 to yield a statistically significant
splinting found a significant improvement for lateral pinch after result. The effect size of .47 was used in the analysis because
exercise, but not for reducing symptoms. Rozmaryn et al15 that was the effect size of the CTS Symptom Severity Scale
found that subjects who performed tendon and nerve gliding (SSS) (our primary outcome measure in this study) in a study
exercises had fewer surgeries than the subjects who did not by Akalin,14 which compared a CTS group that wore a neutral
perform the exercises. This was a retrospective study, however, wrist splint with a second group that wore a neutral wrist splint
and subjects did not follow a standard treatment protocol, thus and performed tendon and nerve gliding exercises. To com-
making it difficult to determine whether the improvement re- pensate for withdrawals, we oversampled by 21 subjects, which
sulted solely from the tendon and nerve gliding exercises, or resulted in a total of 61 subjects.
from a combination of interventions.
Our purpose in this randomized controlled trial (RCT) was to Study Design
compare the efficacy of a fabricated, customized splint that We used a randomized 2 (splint) by 2 (exercise) by 3 (time)
positions the wrist and the MCP joints in neutral (neutral wrist factor design for the primary outcome measure and a 2 (splint)
and MCP) with an off-the-shelf, wrist cock-up splint, with and by 2 (exercise) by 2 (time) factor design for the secondary
without tendon and nerve gliding exercises, in the treatment of outcome measures. The independent variable, splint, consisted
CTS. We studied 4 groups that received the following inter- of 2 levels: a fabricated neutral wrist splint that included the
ventions: fabricated neutral wrist and MCP splint with no MCP joints and an off-the-shelf wrist cock-up splint. The
exercises (neutral wrist and MCP); fabricated neutral wrist and independent variable, exercise, consisted of 2 levels: tendon
MCP splint with tendon and nerve gliding exercises (neutral and nerve gliding exercises and no exercises. The independent
wrist and MCP-exercise); off-the-shelf, wrist cock-up splint variable, time, consisted of 3 levels for the primary outcome
with no exercises (wrist cock-up), and off-the-shelf, wrist measure: baseline, 4-week post-test, and 8-week follow-up,
cock-up splint with tendon and nerve gliding exercises (wrist and 2 levels for the secondary outcome measures of baseline
cock-up-exercise). and 4-week post-test.
Our hypotheses were: (1) all treatments would reduce CTS
symptoms and improve functional status over time; (2) the Interventions
groups that received the fabricated neutral wrist and MCP There were 4 groups. Subjects in the neutral wrist and MCP
splint would evince greater reduction in symptom severity and and neutral wrist and MCP-exercise groups received a custom-
improvement in functional status than the groups that received ized, fabricated wrist splint positioning the wrist in neutral (0°)
the wrist cock-up splint (neutral wrist and MCP and neutral and the MCP joints from 0° to 10° of flexion (fig 1). Subjects
wrist and MCP-exercise versus wrist cock-up and wrist in the wrist cock-up and wrist cock-up-exercise groups re-
cock-up and exercise); and (3) the groups that performed the ceived a prefabricated, off-the-shelf wrist cock-up splint that
exercises would show greater reduction in symptom severity immobilized the wrist in 20° of extension (fig 2). Subjects who
and improvement in functional status than the groups that did received the prefabricated splint were fitted with the appropri-
not perform exercises (neutral wrist and MCP-exercise and ate size (extra small, small, medium, large) and the splint was
wrist cock-up-exercise vs neutral wrist and MCP and wrist
cock-up).
METHODS
Participants
The trial included 61 subjects (14 men, 47 women) who
were recruited from the University of Pittsburgh Medical Cen-
ter’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 Fig 1. Fabricated splint placed the wrist and MCP joints in a neutral
been due to an underlying cause, eg, diabetes mellitus, or position and was worn by neutral wrist and MCP and the neutral
thyroid disease); were pregnant (CTS symptoms may resolve wrist and MCP-exercise groups.
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
Fig 2. Off-the-shelf, wrist cock-up splint worn by the wrist cock-up was made after subjects gave their informed consent and base-
and wrist cock-up-exercise groups. line assessments were completed. Subjects were randomized
into groups by selecting a sealed opaque envelope that con-
tained a number corresponding to an intervention group. The
primary investigator administered all interventions, including
shaped to provide the best comfortable fit. All subjects were fabricating the customized splint and teaching the exercises.
told to notify the primary investigator (TLB) of any discomfort
when wearing the splint. All groups were instructed to wear the Adherence to Protocol
splint during their regularly scheduled sleep time for 4 weeks.
In addition, subjects in the neutral wrist and MCP-exercise and Adherence to the treatment protocol was tracked in a daily
the wrist cock-up-exercise groups received visual and verbal log that subjects returned to the principal investigator weekly.
instructions on tendon and nerve gliding exercises.27 Subjects Subjects were instructed to record how often they wore the
were instructed to perform the exercises 3 to 5 times a day, splint (all night, half the night, not at all) and how many
with 10 repetitions in each position, and to hold each position sessions of the exercise program they performed during the
for 5 seconds. Subjects showed their competency with the day. At the end of each week, subjects were contacted by
exercise program by verbally describing and visually demon- telephone and reminded to wear the splint and to continue to
strating the exercises to the primary investigator. All groups perform prescribed tendon and nerve gliding exercises. Adher-
received an educational brochure written by the hand clinic ence to the protocol was defined as wearing the assigned splint
physicians that explained CTS signs, symptoms, and treat- at night at least 80% of the time, and performing the tendon and
ments. After 4 weeks, subjects were instructed to wear their nerve gliding exercises a minimum of 3 times a day 80% of the
splints and to perform exercises as needed to manage CTS time.
symptoms.
Data Analysis
Outcome Measures Descriptive statistics were computed for subject demograph-
The primary outcome measure, the CTS SSS and Func- ics and baseline clinical characteristics. We used 1-way anal-
tional Status Scale (FSS),28 is a subjective questionnaire that ysis of variance (ANOVA) tests to compare baseline charac-
evaluates symptom severity and functional status in subjects teristics for continuous variables, and the Kruskal-Wallis test to
with CTS. It consists of 2 subscales: the 11-item SSS (eg, compare the categorical variables.
numbness, tingling, pain) and the 8-item FSS (eg, writing, The effects of type of splint and exercise over time were
buttoning). Response options range from 1 point (no symp- analyzed with a 2⫻2⫻3 mixed-model ANOVA for the subjec-
toms or no difficulty performing activities) to 5 points (most tive measure subscales and a 2⫻2⫻2 mixed-model ANOVA
severe pain or unable to perform activity). Subjects with for the objective measures. Data on the 51 subjects who com-
bilateral CTS were instructed to answer the questions with pleted the protocol were used in these analyses. In addition, we
regard to the hand that was being studied. Subscale scores did an intention-to-treat (ITT) analysis on the 61 subjects who
are the mean of each subscale and range from 1 to 5; higher consented to participate in the study to preserve the effect of
scores indicate greater impairment or disability. This mea- randomization, and to consider the practical impact of treat-
sure is highly reproducible, internally consistent, valid, and ment.
responsive to clinical change.28 The clinical significance was analyzed using partial 2,
Objective secondary outcome measures were the Moberg which we selected because it only considers the effect of
Pick-up Test,29 grip strength, and pinch strength. The Moberg interest and eliminates the influence of other factors, thus
Pick-up Test is commonly used to evaluate functional sensi- preventing more powerful variables from skewing the results.31
bility. The test reflects fine motor performance and requires an Descriptive statistics, inferential statistics, and effect sizes were
ability to perceive constant touch and to use precision sensory calculated with SPSS (version 12.0)a for Windows.
pinch. Subjects are timed on how quickly they pick up an
assortment of objects such as a coin, safety pin, and paper clip, RESULTS
and place them in a small box. We measured grip strength with Sixty-one of 79 eligible patients enrolled in the study. Four
a hand-held dynamometer,b which is a sensitive and repeatable subjects withdrew because: they had an injection or surgery
testing instrument.30 Subjects were given 3 opportunities to (n⫽2), developed an illness (n⫽1), or moved out of the area
exert maximum force; we recorded the mean of 3 successive (n⫽1); 6 subjects were lost to follow-up (fig 3). Thus, 51
trials. Pinch strength was measured with a reliable and accurate subjects (10 men, 41 women) completed the study. Their mean
hand-held pinch meter.30,c Subjects had 1 opportunity to exert age was 50 years (range, 21⫺86y) and 55% of the subjects
maximum force with 3 types of pinch: tip pinch, lateral pinch, reported bilateral CTS. All groups were similar in demographic
and palmar pinch. and clinical characteristics at baseline (table 1).
All subjects completed a demographic and CTS history The results of the means and mixed-model ANOVAs pro-
questionnaire that included questions regarding age, sex, hand duced a significant Mauchly test of sphericity for the dependent
11 not interested
2 out of town
5 opted for other treatment
61 randomized
variables, indicating that the assumption of sphericity had been 8 weeks. In addition, the main effect of time was significant for
violated, thus, we used the Greenhouse-Geisser correction fac- the secondary objective outcome measures of tip pinch
tor. There were no significant 2- or 3-way interaction effects (F1,47⫽7.79, P⫽.008) and palmar pinch (F1,47⫽4.75, P⫽.034).
with the other factors; however, both time (within groups) and All groups significantly improved tip pinch strength from base-
splint (between groups) produced significant main effects. line (mean, 4.75kg [10.56lb]) to 4 weeks (mean, 5.13kg
The main effect of splint was significant for the primary [11.40lb]), and palmar pinch strength from baseline (mean,
subjective outcome measure subscales (CTS SSS, F1,47⫽6.45, 6.17kg [13.70lb]) to 4 weeks (mean, 6.55kg [14.55lb]). There
P⫽.014; FSS, F1,47⫽5.10, P⫽.029). Overall, the neutral wrist were no significant main effects for exercise on any of the
and MCP splint group reported a greater reduction in symp- outcome measures.
toms (mean, 2.045) than the wrist cock-up splint group (mean, In addition to the on-protocol analysis, we conducted an ITT
2.508). Further analysis demonstrated that the neutral wrist and analysis using the mixed-model ANOVA. The results were
MCP splint had a medium effect on CTS symptoms (partial similar to the on-protocol analyses, except the ITT analysis
2⫽.12) and functional status (partial 2⫽.10). The results of found a significant effect of time on grip strength (F1,57⫽4.41,
the satisfaction survey provided further evidence of the effec- P⫽.04).
tiveness of the neutral wrist and MCP splint; 38% of the
subjects randomized to that group reported “no to occasional Adherence to Protocol and Subject Satisfaction
symptoms” after 8 weeks; in comparison, 17% of the subjects Overall, subjects adhered to the requirements for wearing the
randomized to the wrist cock-up splint group reported this splint. According to self-reports, 88% of the subjects reported
frequency of symptoms. wearing their splint all night at least 80% of the time and the
The main effect of time showed a significant improvement remaining subjects reported wearing it at least 50% of the time.
on the subjective primary outcome measure subscales (CTS In addition, 93% of the subjects who wore the neutral wrist and
SSS, F1.7,81.59⫽27.26, P⬍.001; FSS, F1.6,75.93⫽17.39, MCP splint, compared with 88% of subjects who wore the
P⬍.001). Post hoc testing revealed differences for the pairwise wrist cock-up splint, reported that it was comfortable and that
comparison on the CTS SSS between baseline (mean, 2.65) and they would continue to wear the splint as needed.
4 weeks (mean, 2.08) and baseline (mean, 2.65) and 8 weeks Adherence to the tendon and nerve gliding exercise program
(mean, 2.08); the FSS between baseline (mean, 2.15) and 4 was also high; 81% of the subjects performed the exercises at
weeks (mean, 1.77) and baseline (mean, 2.15) and 8 weeks least 80% of the time and the remaining subjects performed
(mean, 1.72). Over time, all groups, regardless of splint and them at least 50% of the time. Two subjects who reported
exercise, had significantly decreased CTS symptoms and im- partial compliance reported that the exercises increased the
proved functional status and maintained that improvement for pain in their wrists.
Demographic
Age (y) 51.9⫾15.7 49.0⫾15.4 50.1⫾13.2 46.6⫾12.9 .83
Sex .34
Male 3 1 4 2
Female 10 13 9 9
Hand dominance .11
Right 8 11 8 7
Left 5 3 5 4
Bilateral CTS 6 8 6 6 .28
Race .71
White 13 13 8 11
Black 0 1 2 0
Other 3
Employment status .60
Full-time 6 6 9 7
Part-time 3 3 2 2
Not working 4 5 2 2
Symptom duration .73
0⫺6mo 3 5 6 3
6⫺12mo 2 3 1 4
1⫺2y 3 2 2 1
⬎2y 5 4 4 3
Cause of CTS .82
Occupation 5 8 8 4
Other 8 6 5 7
Clinical
CTS SSS† 2.5⫾0.5 2.4⫾0.8 2.9⫾0.9 2.8⫾0.8 .31
CTS FSS† 1.8⫾0.7 2.2⫾0.8 2.4⫾0.8 2.2⫾0.9 .20
Moberg Pick-up Test (s) 15.2⫾5.0 15.6⫾5.0 16.4⫾6.0 14.0⫾4.2 .69
Grip strength‡ (lb) 62.3⫾33.6 48.3⫾16.8 58.5⫾32.9 53.3⫾19.7 .57
Tip pinch‡ (lb) 11.4⫾5.5 9.9⫾3.3 12.0⫾5.5 9.0⫾2.9 .35
Palmar pinch‡ (lb) 14.8⫾5.9 13.2⫾4.7 13.9⫾5.4 12.9⫾3.3 .79
Lateral pinch‡ (lb) 16.2⫾5.7 15.7⫾4.7 16.5⫾7.5 14.7⫾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 (␣) set at .05.
†
Higher scores indicate greater impairment.
‡
Higher scores indicate lesser impairment.
Of the many studies on splinting for CTS, we found only 123 investigator by giving favorable answers concerning the sub-
that evaluated the effects of finger positioning on CTS symp- jective outcome measures and by trying harder on the objective
toms and function. Manente et al23 reported that subjects who outcome measures.
wore a hand brace had significantly reduced CTS symptoms The short-term follow-up was another limitation. This study
and improved functional status. Manente did not consider the administered subjective and objective measures at 4 weeks and
position of the wrist, however, and they compared the splint subjective measures only at 8 weeks. Thus, recurrence rates
group with a control group that did not receive any treatment. and long-term results are unknown.
Because there is evidence that immobilizing the wrist is an Despite its limitations, the study had its strengths: it was an
effective treatment for CTS33,34 it is unclear if the hand brace RCT, the outcome measures are reliable and valid, and are
is more efficacious than a traditional wrist splint. In this study, commonly used in clinics.
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 Future Research
splint. In this study, the majority of subjects reported a history of
This study did not support our third hypothesis that there CTS, and another medical provider had treated many of them
would be a significant difference in CTS symptom severity and before they enrolled in the study. Future research should focus
functional status between the groups that received exercises on evaluating the effectiveness of the fabricated customized
compared with the groups that did not. These results differed neutral wrist and MCP splints for patients newly diagnosed
from other studies that evaluated the effects of tendon and with CTS and in patients with CTS symptoms resulting from
nerve gliding exercises.14,15 Rozmaryn et al15 found that sub- the lumbrical muscles migrating into the carpal tunnel. Fur-
jects who received tendon and nerve gliding exercises under- thermore, this study followed subjects for only 8 weeks. Future
went surgery 28% less often than those who received tradi- research should include a longer-term follow-up and more
tional treatment. Theirs was a retrospective study that provides frequent evaluations to determine if this splint is more effective
a lower level of evidence than an RCT, and the groups did not than traditional splints for the long-term treatment of CTS. Our
follow a standard treatment protocol. Akalin et al14 compared results do not support the use of tendon and nerve gliding
subjects who wore splints with subjects who wore splints and exercises in treating CTS, contrary to what others have re-
performed tendon and nerve gliding exercises. They reported ported.14,15 Future studies, with larger sample sizes and a more
that both groups improved, and there was a significant differ- strenuous adherence to the exercise arm of the protocol, need to
ence between the groups on lateral pinch strength. Adherence be conducted to determine the effectiveness of these exercises
to the protocol was not reported, however, which made it in the treatment of CTS.
difficult to determine if and how often subjects followed their
prescribed exercise regime. CONCLUSIONS
Study Limitations CTS is among the most commonly diagnosed upper-extrem-
This study had several limitations. An orthopedic hand sur- ity neuropathies. Rising health care and indemnity costs are
geon who practices in a large, academic medical center outpa- just a few of the many implications of CTS for modern society.
tient hand clinic referred the subjects. Thus, many subjects had Determining safe, effective, and economic conservative inter-
sought treatment for their CTS elsewhere, and/or the cases seen ventions for the treatment of mild-to-moderate CTS should be
by the hand surgeon were more severe. Approximately 41% of a priority. The purpose of this study was to compare the effects
the subjects were treated previously with a splint or anti- of a fabricated customized neutral wrist and MCP splint to a
inflammatory medications before being seen by the hand sur- wrist cock-up splint, with and without tendon and nerve gliding
geon. Furthermore, 67% of the subjects who completed the exercises, for the treatment of mild-to-moderate CTS. Our
study had symptoms of CTS for longer than 6 months, which results provide further evidence of the effectiveness of splint-
may have minimized the effect of treatment. Splinting is most ing, designed to target an underlying anatomic problem, for
effective if prescribed within the first 3 months of symptoms reducing symptoms and improving functional status in patients
onset.36 with mild-to-moderate CTS.
Another limitation was our inability to control for other Acknowledgment: The opinions or assertions contained herein
potential confounding variables except through randomization. are the private views of the author(s) and are not to be construed as
For example, other interventions such as anti-inflammatory official or as reflecting the views of the U.S. Army or the U.S.
medications and injections could not be withheld during the Department of Defense.
study period. Of the 51 subjects, 7.8% were taking anti-inflam-
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