1429
ORIGINAL ARTICLE
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, Joan C. Rogers, PhD, Margo B. Holm, PhD, Nancy A. Baker, ScD,
Zong-Ming Li, PhD, Robert J. Goitz, MD
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. Arch
Phys Med Rehabil 2007;88:1429-35.
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 ther-
apy 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 interac-
tion 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.
From the Department of Occupational Therapy, School of Health and Rehabilita-
tion Sciences, University of Pittsburgh, Pittsburgh, PA (Brininger, Rogers, Holm,
Baker); and Hand Research Laboratory (Li) and Department of Orthopedic Surgery
(Goitz), University of Pittsburgh Medical Center, Pittsburgh, PA (Goitz).
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.
Reprint 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, e-mail: Teresa.Brininger@us.army.mil.
0003-9993/07/8811-00268$32.00/0
doi:10.1016/j.apmr.2007.07.019
© 2007 by the American Congress of Rehabilitation Medi-
cine and the American Academy of Physical Medicine and
Rehabilitation
HE MAJORITY OF PEOPLE who seek medical treatment
T 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.5-7 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 conserva-
tive 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 pre-
scribed for mild-to-moderate CTS.9-11 Once patients present
with severe CTS— characterized by muscular atrophy and sig-
nificant 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 ana-
tomic 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 Clin-
ical 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.18-22 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
Arch Phys Med Rehabil Vol 88, November 2007
1430 EFFICACY OF A FABRICATED CUSTOMIZED SPLINT, Brininger
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 fin-
ger 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.9-11 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 re-
sulted 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 inter-
ventions: 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).
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
been due to an underlying cause, eg, diabetes mellitus, or
thyroid disease); were pregnant (CTS symptoms may resolve
Arch Phys Med Rehabil Vol 88, November 2007
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 ac-
counting for splint and exercise. The criterion for significance
(␣) 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 com-
pensate 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 custom-
ized, 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 re-
ceived 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 appropri-
ate size (extra small, small, medium, large) and the splint was
Fig 1. Fabricated splint placed the wrist and MCP joints in a neutral
position and was worn by neutral wrist and MCP and the neutral
wrist and MCP-exercise groups.
 EFFICACY OF A FABRICATED CUSTOMIZED SPLINT, Brininger
Fig 2. Off-the-shelf, wrist cock-up splint worn by the wrist cock-up
and wrist cock-up-exercise groups.
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 demon-
strating the exercises to the primary investigator. All groups
received an educational brochure written by the hand clinic
physicians that explained CTS signs, symptoms, and treat-
ments. 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 Func-
tional 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 symp-
toms 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 mea-
sure 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 sensi-
bility. 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
1431
dominance, ethnicity, height, weight, and occupation. In addi-
tion, 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 base-
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
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. Adher-
ence 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 demograph-
ics and baseline clinical characteristics. We used 1-way anal-
ysis of variance (ANOVA) tests to compare baseline charac-
teristics 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 subjec-
tive measure subscales and a 2⫻2⫻2 mixed-model ANOVA
for the objective measures. Data on the 51 subjects who com-
pleted 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 treat-
ment.
The clinical significance was analyzed using partial ␩2,
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.
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).
The results of the means and mixed-model ANOVAs pro-
duced a significant Mauchly test of sphericity for the dependent
Arch Phys Med Rehabil Vol 88, November 2007
1432 EFFICACY OF A FABRICATED CUSTOMIZED SPLINT, Brininger
79 met the inclusion criteria
61 randomized
NW/MCP-X NW/MCP WCU-X
n=16 n=17 n=16
2 lost to follow-up 2 lost to follow-up 1 lost to follow-up
1 received injection 1 ill due to medical 1 had surgery
problems not related 1 moved out of area
to the study
13 completed 14 completed 13 completed
study study study
variables, indicating that the assumption of sphericity had been
violated, thus, we used the Greenhouse-Geisser correction fac-
tor. 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 symp-
toms (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
␩2⫽.12) and functional status (partial ␩2⫽.10). The results of
the satisfaction survey provided further evidence of the effec-
tiveness 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 im-
proved functional status and maintained that improvement for
Arch Phys Med Rehabil Vol 88, November 2007
11 not interested
2 out of town
5 opted for other treatment
WCU
n=12
1 lost to follow-up
11 completed
study Fig 3. Trial profile. Abbrevia-
tions: NW, neutral wrist; WCU,
wrist cock-up; X, exercise.
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 base-
line (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.
 EFFICACY OF A FABRICATED CUSTOMIZED SPLINT, Brininger 1433

Table 1: Subject Demographic and Clinical Characteristics

NW/MCP-X NW/MCP WCU-X WCU
Characteristics (n⫽13) (n⫽14) (n⫽13) (n⫽11) P*

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.

DISCUSSION status short term.33,34 Furthermore, we found that all groups

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-mod-
erate CTS.
As expected, the study population’s sex and age were con-
sistent 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.5-7
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 sig-
nificantly reduces CTS symptoms and improves functional
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 enter-
ing 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 pres-
sure.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 fabri-
cated neutral wrist and MCP splint may be more effective
than the off-the-shelf wrist cock-up splint.

Arch Phys Med Rehabil Vol 88, November 2007

1434 EFFICACY OF A FABRICATED CUSTOMIZED SPLINT, Brininger
Of the many studies on splinting for CTS, we found only 123
that evaluated the effects of finger positioning on CTS symp-
toms 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 sub-
jects who received tendon and nerve gliding exercises under-
went surgery 28% less often than those who received tradi-
tional 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 differ-
ence 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 sur-
geon who practices in a large, academic medical center outpa-
tient 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 sur-
geon. 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-inflam-
matory medications and 17.6% received an injection after the
4-week period. Therefore, it is not clear whether the improve-
ment 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 medi-
cation to be the most helpful, and 5.8% who reported injection
to be the most helpful.
Another limitation was that the person (TLB) who adminis-
tered 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 feel-
ings and thus affected the results of the outcome measures. For
example, subjects may have wanted to please the principal
Arch Phys Med Rehabil Vol 88, November 2007
investigator by giving favorable answers concerning the sub-
jective 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. Fur-
thermore, 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 re-
ported.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.
CONCLUSIONS
CTS is among the most commonly diagnosed upper-extrem-
ity 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 inter-
ventions 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 splint-
ing, designed to target an underlying anatomic problem, for
reducing symptoms and improving functional status in patients
with mild-to-moderate CTS.
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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Suppliers
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.
Arch Phys Med Rehabil Vol 88, November 2007