Journal of Physiotherapy 66 (2020) 97–104

j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / j p hy s

Research

Group education, night splinting and home exercises reduce conversion to

surgery for carpal tunnel syndrome: a multicentre randomised trial
Karina J Lewis a,b, Michel W Coppieters c,d, Leo Ross e, Ian Hughes f, Bill Vicenzino g,*,
Annina B Schmid h,*
a
Occupational Therapy Department, Gold Coast University Hospital, Gold Coast, Australia; b School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane,
Australia; c Menzies Health Institute Queensland, Griffith University, Brisbane and Gold Coast, Australia; d Amsterdam Movement Sciences, Faculty of Behavioural and Movement
Sciences, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands; e Allied Health Department, Queen Elizabeth II Jubilee Hospital, Brisbane, Australia; f Gold Coast University
Hospital, Southport, Australia; g The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Australia; h Nuffield Department of Clinical Neurosciences,
University of Oxford, United Kingdom

K E Y W O R D S A B S T R A C T

Carpal tunnel syndrome Question: In people with carpal tunnel syndrome who are waitlisted for surgical consultation, does a
Surgery therapist-led care pathway involving education, splinting and exercises reduce the need for surgery and
Rehabilitation
improve patient outcomes? Design: A multicentre, randomised controlled trial with concealed allocation,
Physical therapy
blinded assessment and intention-to-treat analysis. Participants: One hundred and five people with elec-
Occupational therapy
trodiagnostically confirmed carpal tunnel syndrome on a waitlist for surgical consultation and recruited from
four public hospitals in Australia. Interventions: The experimental group (n = 52) received a one-off group
session of education, splinting, and nerve and tendon gliding exercises. The control group (n = 53) continued
on the waitlist without additional care. Outcome measures: The primary outcome measures were conver-
sion to surgery by 24 weeks, the global rating of change (GROC) scale and patient satisfaction. Secondary
outcomes included symptom severity and functional limitation. Results: At 24 weeks, conversion to surgery
was 59% in the experimental group and 80% in the control group (risk difference 20.21, 95% CI 20.38
to 20.03). More participants in the experimental group identified as improved at 6 weeks (20% vs 4%; risk
difference 0.15, 95% CI 0.03 to 0.28) but not at 24 weeks (24% vs 10%; risk difference 0.14, 95% CI 20.01 to
0.29). The intervention was also estimated to be beneficial on some measures of satisfaction, symptom
severity and functional limitation. The study’s estimates of the benefits came with some uncertainty, which
makes it unclear whether the wider population of people awaiting carpal tunnel surgery would consider that
the benefits make the intervention worthwhile. No serious adverse effects were reported. Conclusions: A
therapist-led pathway reduced conversion to carpal tunnel surgery and increased perceived improvement
and satisfaction in people who were already on a waitlist for surgical consultation. Registration:
ACTRN12613001095752. [Lewis KJ, Coppieters MW, Ross L, Hughes I, Vicenzino B, Schmid AB (2020)
Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel
syndrome: a multicentre randomised trial. Journal of Physiotherapy 66:97–104]
© 2020 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under
the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Introduction The increasing burden of managing CTS and its inclusion as a

Carpal tunnel syndrome (CTS) is the most common entrapment
neuropathy. Surgery is often recommended and, with a lifetime surgical
prevalence of . 3%,1 it is the most common upper limb orthopaedic
surgery.2 Annual costs of surgery are estimated at . US$ 2 billion in the
United States.3 Available data suggest that the waitlists for CTS surgery
are long, ranging from 2 to 10 months, with many countries in Northern
America, Europe and Australia having wait times . 5 months.2,4,5 The
demand for CTS surgery is predicted to double over the next decade,
which poses a serious challenge for health systems.6
*
contributed equally to this work.
‘restricted procedure’ on the UK National Health Service7 mandates
study of alternative management pathways. Therapist-led clinics aimed
at expediting access to care and reducing surgical waitlists have been
implemented,8,9 with retrospective reports of positive impact.8–10 In
these studies, a reduction in waitlists was observed, resulting from
earlier surgery or a reduction in conversion to surgery. These promising
preliminary findings warrant prospective investigation.
Therefore, the research question for this multicentre, randomised
controlled trial was:
In people with carpal tunnel syndrome who are waitlisted for
surgical consultation, does a therapist-led care pathway involving

https://doi.org/10.1016/j.jphys.2020.03.007
1836-9553/© 2020 Australian Physiotherapy Association. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/).
98 Lewis et al: Non-surgical management of carpal tunnel syndrome
education, splinting and exercises reduce the need for surgery and
improve patient outcomes?
Methods
Design
A multi-centre randomised controlled trial was conducted with
participants recruited from the waiting list for carpal tunnel surgery at
each of four public hospitals in Australia. As outlined in the published
and prospectively registered protocol,11 eligible participants were
randomly allocated to an experimental group or a control group. The
experimental group received education, splinting (orthosis) and a
home program of exercises. The control group received current
management, which consisted of continuing on the waiting list
without additional care. The random allocation schedule was com-
puter generated on a randomisation website and concealed via sealed
envelopes by an investigator who was not involved in the interven-
tion, outcome assessment or statistical analysis. Randomisation was
stratified into mild/moderate or severe CTS, according to the cate-
gories of electrophysiological severity defined by Bland,12 which are
presented in Table 1 on the eAddenda. For participants with bilateral
CTS, both sides were managed as per group allocation and one hand
was chosen randomly for assessment. Participants were reassessed 6
and 24 weeks later. Participants and treating clinicians could not be
masked to the intervention. The outcome measures involved some
degree of self-report by participants. Nevertheless, the investigators
involved in outcome assessment and the statistician who performed
the data analysis were blinded to group allocation during recruitment,
data collection and preliminary analyses. Participants were reminded
at the start of their scheduled appointments to not disclose their
group allocation to the outcome assessor or orthopaedic surgeon. Trial
processes including interventions and outcome assessments were
standardised among the four study centres via training and supervi-
sion provided by the study coordinator. Site coordinators and senior
therapists were available to provide guidance in relation to imple-
mentation of the research protocol and provide clinical assistance as
required. The trial is reported according to the CONSORT guidelines.13
Participants and centres
Participants were recruited from among people with a clinical
diagnosis of CTS confirmed by nerve conduction studies and who
were referred by their general practitioner to the waiting list for
surgical consultation at each of four publicly funded hospitals in
Queensland, Australia (Queen Elizabeth II Jubilee Hospital Brisbane,
Rockhampton Hospital, Logan Hospital, Gold Coast University Hos-
pital). At the time the study started, waiting lists for surgical con-
sultations in participating hospitals ranged from 1 to 5 years. To be
eligible for inclusion, patients had to: be aged between 18 and 75
years (older patients were excluded because of the anticipated
prevalence of comorbidities); have experienced symptoms for . 2
months; and be able to comprehend the requirements of the study
and provide consent.
Exclusion criteria were: osteoarthritis of the wrist or hand; other
musculoskeletal or neurological conditions affecting the upper limb
(eg, trigger finger, cervical radiculopathy); pending litigation or in-
surance claims; and CTS related to trauma, systemic diseases (other
than diabetes) or pregnancy. People who had received a steroid in-
jection within the previous 6 months or hand therapy interventions
(splinting or exercises) within the previous 3 months were also
excluded, to avoid carry-over effects of these interventions. Detailed
selection criteria are presented in Box 1 on the eAddenda.
Interventions
Experimental group
Education, splinting and home exercises were provided by a
physiotherapist or an occupational therapist during a single group
appointment (w30 minutes) and continued as a home-based pro-
gram. Education included a presentation and booklet regarding CTS
pathophysiology, treatment options (conservative management and
surgery), posture and activity modification principles. The presenta-
tion and booklet are available as Appendices 1 and 2 on the
eAddenda.
Participants in the experimental group also received a wrist
orthosis with a custom palmar stay to position the wrist in a neutral
position. They were advised to wear the splint during the night only.
In addition to education and splinting, participants were prescribed a
home exercise program consisting of median nerve-gliding and
tendon-gliding exercises.11 These exercises have been shown to
reduce symptoms14–16 and intraneural oedema in people with CTS.17
They were asked to perform 5 to 10 repetitions of each exercise five
times a day, provided that there was no increase in their symptoms. A
detailed explanation of these interventions is reported in the study
protocol.11
Control group
The control group continued to be on the waiting list for surgical
consultation, as per current practice, without receiving any of the
interventions described above. After the trial, participants in the
control group who had not already had surgery were offered
the interventions that had been given to the experimental group.
Outcome measures
During the initial appointment (Week 0), the medical history,
demographic data, electrodiagnostic test severity and baseline data
were collected. Outcome measures were collected at Weeks 6 and 24
by a local trial clinician who was blinded to group allocation. At Week
24, participants also attended a consultation with an orthopaedic
surgeon. The schedule of assessments is tabulated in Table 2 on the
eAddenda.
Primary outcomes
The primary outcome measures were conversion to surgery, the
global rating of change (GROC) scale18 and participant satisfaction. As
per usual hospital practice, conversion to surgery (ie, the decision to
proceed with surgery) was determined by an orthopaedic surgeon
during an orthopaedic consultation. This consultation occurred at
Week 24, or earlier if the participant experienced a significant
symptom deterioration. The surgeon was blinded to group allocation.
The GROC scale was used to assess the participants’ perceived change
and was measured using a 15-point scale ranging from ‘a very great
deal worse’ (27) to ‘a very great deal better’ (17) at Weeks 6 and 24.
A score of ‘a good deal better’ (15) or higher was classified as
success.19
Participants’ satisfaction with treatment, function and overall
progress was collected using a questionnaire adapted from Hall
et al.20 The scale consisted of seven questions, each with a 10-point
Likert scale ranging from 0 (very unsatisfied/strongly disagree) to
10 (very satisfied/strongly agree) with a maximum total score of 70.
The seven scales are presented in Appendix 3 on the eAddenda.
Secondary outcomes
Participants’ symptom severity was assessed using the Symptom
Severity Scale of the Boston CTS Questionnaire,21 and the self-report
version of the Leeds Assessment of Neuropathic Symptoms and Signs
scale (S-LANSS).22 Participants’ functional limitations were assessed
using the Functional Status Scale of the Boston CTS Questionnaire,21
the full version of the Disability of the Arm, Shoulder and Hand
(DASH)23 and the Patient-Specific Functional Scale (PSFS).24 Symptom
distribution was assessed with a hand and body diagram and inter-
preted using the scale described by Katz,25 with a specific focus on
the number of patients with symptoms outside the classic median
nerve distribution (extra-median spread and/or proximal spread of
symptoms). Patients were asked to complete all questionnaires for
the studied hand. Adverse events were recorded.
 Research 99

Adherence to the exercise program and splinting were monitored Table 3

separately by the treating therapists, using the following classifica- Characteristics of the participants at baseline.

tion. For splinting, complete adherence meant that the participant Characteristic Exp Con Total
reported wearing the orthosis nightly, whereas complete non- (n = 52) (n = 53) (n = 105)
adherence meant that the participant reported not wearing the Age (y), mean (SD) 51 (12) 48 (13) 49 (12)
orthosis at all. The remaining participants were classified as partially Sex, n (%) female 41 (79) 32 (60) 73 (70)
adherent to splinting. For exercises, complete adherence meant Right handed, n (%) 43 (90)a 44 (96)b 87 (93)
Bilateral symptoms, n (%) 44 (85) 40 (75) 84 (80)
completion of exercises at least five times per day and correct per- Comorbidities, n (%)
formance observed by a therapist during the review appointment, any 45 (87) 40 (75) 85 (81)
whereas complete non-adherence meant that the participant re- diabetes 3 (6) 7 (13) 10 (10)
ported not completing any exercises. The remaining participants were thyroid dysfunction 6 (12) 6 (11) 12 (11)
other musculoskeletal 12 (23) 11 (21) 23 (22)
classified as partially adherent to exercises. Any co-interventions
mental health 17 (33) 10 (19) 27 (26)
were also recorded in both groups. cardiovascular 22 (42) 17 (32) 39 (37)
Occupation, n (%)
unemployed/retired 19 (37) 15 (28) 34 (32)
Data analysis
office-based duties 9 (17) 12 (23) 21 (20)
moderately heavy 6 (12) 4 (8) 10 (10)
A power calculation based on conversion to surgery as the primary manual labour 18 (35) 22 (42) 40 (38)
outcome measure indicated that 64 participants were required per Presence of thenar wasting, n (%) 11 (22)c 8 (17)d 19 (20)
group (128 total). This would be sufficient power to detect a 25% Duration of symptoms (y), mean (SD) 3.7 (4.2) 4.0 (4.2) 3.8 (4.2)
Electrodiagnostic test grade, n (%)
decrease in conversion to surgery from 69% to 44%,8 with a power of 80% normal 0 (0) 0 (0) 0 (0)
at a 5% significance level and allowing for a 5% loss to follow-up rate. It very mild 0 (0) 1 (2) 1 (,1)
was anticipated that stratification due to electrodiagnostic test severity mild 20 (38) 19 (36) 39 (37)
would allocate 43 mild/moderate and 21 severe cases into each group. moderate 20 (38) 22 (42) 42 (40)
severe 6 (12) 4 (8) 10 (10)
Data were analysed using commercial softwarea on an intention-
very severe 5 (10) 7 (13) 12 (11)
to-treat basis with two-sided analyses. Missing values were extremely severe 1 (2) 0 (0) 1 (,1)
assessed for their extent and nature of missingness. If less than 10% of
Con = control group, Exp = experimental group.
data was missing and the nature of the missingness did not a
4 missing.
compromise the analyses being undertaken, the available data were b
7 missing.
analysed without any modification. Otherwise, an inverse probability c
3 missing.
d
weighting method was used to take into consideration missing data. 5 missing.
The effect of the experimental intervention on conversion to
surgery estimated using Fisher’s exact test and reported as a risk
it became obvious that insufficient information was able to be
difference with a 95% CI. The effect of the experimental intervention
accessed for cost-effectiveness analyses, so no cost-effectiveness data
on the likelihood of success on the GROC scale was analysed and
are presented. Four months after trial commencement, eligibility
reported the same way. The effect of the experimental intervention
criteria were relaxed to address a slower than anticipated recruitment
on participant satisfaction (total score and score for each question)
rate by including people with diabetes and CTS. Furthermore, the trial
were evaluated at Weeks 6 and 24 with t-tests, and reported as mean
was extended to include other centres at 16 months. This was done
differences with 95% CI. The remaining continuous secondary out-
because the recruitment rate indicated that the target sample size
comes were analysed at Weeks 6 and 24 by regression analyses with
would be missed within the maximum timeframe of the study. Long-
the baseline value used as a covariate. Other covariates considered in
term follow-up data were also collected on 18 June 2019 to determine
multivariable models were sex, age, diabetes, baseline DASH and
whether or not patients who were taken off the surgery waitlist
electrodiagnostic severity grade. Certain plausible interaction effects,
(experimental and control groups) were eventually operated on.
such as electrodiagnostic severity grade by group, were also tested in
This was achieved by screening hospital records as well as by
models. The effect of the experimental intervention on the likelihood
re-contacting patients. All changes gained ethics approval.
of symptoms spreading wider than the classic median nerve distri-
Some deviations from the prescribed interventions were recorded.
bution or proximal to the wrist was estimated using Fisher’s exact
In the control group, one participant underwent CTS surgery funded
test and reported as a risk difference with a 95% CI. Adherence to the
by a private insurer, one purchased their own orthoses and two were
home program was analysed descriptively.
reviewed by the orthopaedic team and offered surgery prior to Week
24 follow-up due to significant symptom exacerbation. Within the
Results experimental group, one participant received a steroid injection and
one was reviewed by the orthopaedic team at 20 weeks due to an
Flow of participants, therapists and centres through the study unrelated referral.

Trial recruitment started on 31 October 2013 and recruitment was
closed at 105 participants on 2 November 2016, due to the slower
than anticipated recruitment rate, reduced staff numbers and an
organisational change in usual care around waiting lists (which
included implementation of the experimental intervention at one
site) that compromised further recruitment. Randomisation allocated
52 participants to the experimental group and 53 to the control
group. The groups were comparable at baseline, as presented in
Table 3 and in the Week 0 data in the remaining tables. Two partic-
ipants in the experimental group and two participants in the control
group did not complete the study (Figure 1).
Adherence to the trial protocol
Amendments were made to the initially approved and registered
protocol. In the first couple of months after recruitment commenced,
Effect of intervention
Primary outcomes
The proportion of participants who converted to surgery was 29/
49 (59%) in the experimental group and 41/51 (80%) in the control
group (Table 4). Therefore, the study’s estimate of the effect of the
experimental intervention on the likelihood of conversion to surgery
was a risk difference of 20.21 (95% CI 20.38 to 20.03). All patients
with diabetes converted to surgery (experimental 3/3, control 7/7).
At Week 6, the proportion of participants who reported a GROC of
 15 was 9/46 (20%) in the experimental group and 2/48 (4%) in the
control group (Table 4). Therefore, the study’s estimate of the effect of
the experimental intervention at Week 6 on the likelihood of success
on the GROC was a risk difference of 0.15 (95% CI 0.03 to 0.28). By
Week 24, the estimate was less beneficial, with a risk difference of
0.14 (95% CI 20.10 to 0.29).
100 Lewis et al: Non-surgical management of carpal tunnel syndrome

Assessed for eligibility (n = 477)

..
Excluded (n = 372)
recent use of therapy, splint or injection (n = 103)

..
> 75 years old (n = 88)
other peripheral neuropathy or neurological condition (n = 60)

..
systemic medical conditions (n = 49)
no nerve conduction study completed (n = 45)
referred to multiple hospitals and likely to receive surgery

..
within 6 months elsewhere (n = 10)
symptoms resolved at time of screening (n = 7)

..
previous carpal tunnel release (n = 6)
work cover claim (n = 3)
pregnant (n = 1)

Measured Boston Symptom Scale, Boston Functional Scale, Patient Specific Functional
Scale, DASH and S-LANSS (n = 105)
Week 0
Randomised (n = 105)
(n = 52) (n = 53)

..
Experimental Group
. Control Group

. .
education remain on waiting

..
Lost to follow-up (n = 2) Lost to follow-up (n = 2)
splinting list for surgery
symptoms resolved did not attend for
exercises
and no longer wished unknown reason (n = 2)

.
remain on waiting
to attend (n = 1)
list for surgery
did not attend for
unknown reason (n = 1)

Measured GROC, satisfaction, Boston Symptom Scale, Boston Functional Scale, Patient-
Week 6 Specific Functional Scale, DASH and S-LANSS
(n = 50) (n = 51)

Measured conversion to surgery, GROC, satisfaction, Boston Symptom Scale, Boston

Week 24 Functional Scale, Patient-Specific Functional Scale, DASH and S-LANSS

(n = 50) (n = 51)

Figure 1. Design and flow of participants through the trial.

DASH = Disability of Arm, Shoulder and Hand, GROC = global rating of change, S-LANSS = self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs scale.

The experimental intervention was also beneficial on the com-
bined satisfaction score. On this score, which is rated from 0 to 70, the
effect of the experimental intervention was estimated as 13 (95% CI 7
to 17) at Week 6 and 11 (95% CI 6 to 16) at Week 24 (Table 5).
Secondary outcomes
The experimental intervention was also estimated to be beneficial
on the individual satisfaction scores. On most of these seven scores,
which are rated from 0 to 10, the effect of the experimental inter-
vention was estimated to be between 1 and 3 approximately. Detailed
results for each of the seven scores at Weeks 6 and 24 are presented
in Table 5.
The effect of the experimental intervention on the Symptom
Severity Scale of the Boston CTS Questionnaire at Week 6 was
estimated as a reduction in severity of 0.31 (95% CI 0.10 to 0.52) on
the 1-to-5 scale. The estimate was similar at Week 24 (Table 6).
The mean estimates of the effect of the experimental intervention
on the S-LANSS were that the experimental intervention might be
beneficial by 1 to 2 points on the 0-to-24 scale. However, the 95% CIs
around these estimates crossed 0, indicating uncertainty about the
true average effect of the treatment on this outcome (Table 6).
There were mixed results among the three measures of functional
limitation. The Functional Status Scale of the Boston CTS Question-
naire had favourable mean estimates, but the 95% CIs crossed 0, again
indicating uncertainty about the true average effect of the treatment.
On the DASH, the estimate at Week 6 favoured the experimental
intervention (adjusted MD 28, 95% CI 213 to 23) but the estimate at
Week 24 was weaker and included the possibility of no effect. On the
PSFS, the estimate at both time points was that the experimental
 Research 101

Table 4
Number (%) of participants in each group, and risk difference (95% CI) between groups for the dichotomous primary outcomes.

Outcome Groups Risk difference between groups

(95% CI)

Week 6 Week 24 Week 6 Week 24

Exp Con Exp Con Exp relative Exp relative to

(n = 46) (n = 48) (n = 49) (n = 51) to Con Con
Conversion to 29 41 20.21
surgery, n (%) (59) (80) (20.38 to 20.03)

GROC  5, n 9 2 12 5a 0.15 0.14

(%) (20) (4) (24) (10) (0.03 to 0.28) (20.01 to 0.29)

Conversion to surgery is defined as recommended surgery by their treating surgeon at Week 24. Global rating of change was scored from 27 (a very great deal worse) to 17 (a very
great deal better), and dichotomised here as a success if the score was 15 or higher (a good deal better). Minor inconsistencies in the table are due to the effects of rounding.
Con = control group, Exp = experimental group, GROC = global rating of change, shaded rows = primary outcomes.
a
3 missing.

intervention improved function by about 1 point on the 0-to-10 scale
and the 95% CIs at both time points estimated favourable effects
about half a point on either side of the mean estimates (Table 6).
The estimate of the experimental intervention’s effect on the
likelihood of symptoms occurring outside median nerve territory
was a reduction of almost 20%. The confidence interval around this
estimate included small reductions and even no reduction, but it
did exclude any worsening effect (Table 7). The estimate of the
effect of the experimental intervention on the likelihood of
symptoms occurring proximal to the wrist was less clear, with the
confidence intervals including important effects in either direction
(Table 7).
Adverse events
No serious or unexpected adverse events were reported. Nine of
the 52 participants allocated to the experimental group reported mild
and transient symptoms such as the orthosis feeling hot (n = 7),
increased finger stiffness upon waking in the mornings after orthosis
use (n = 1), or symptom increase with exercises in the short term (n =
1). While the adverse effects were successfully addressed by use of
cotton orthosis liners and instruction to perform the exercises
through a lesser range of motion, one participant with finger stiffness
discontinued the study.
Post-hoc analyses

Adherence
In the experimental group, complete adherence to splint use was
68% at Week 6 and 51% at Week 24. Complete adherence to the
exercises was 50% at Week 6 and 44% at Week 24. Complete non-
adherence to splint use was 5% at Week 6 and 17% at Week 24.
Complete non-adherence to the exercises was 11% at Week 6 and
22% at Week 24. Among these were three participants who ceased
both exercises and splint use due to full symptom resolution prior
to Week 24. Further details are presented in Table 8 on the
eAddenda.
In addition to the smaller than planned sample size, the low number
of participants with electrodiagnostic tests demonstrating severe CTS
(. grade 3; experimental 23%, control 21%) precluded using it as a
stratum as planned in the analysis. Conversion to surgery was high for
participants with severe CTS (experimental 8/12, control 11/11). Un-
planned post-hoc logistic regression analysis of electrodiagnostic
grades (0 to 6) showed an interaction between group and electro-
diagnostic grade (p = 0.024), such that at electrodiagnostic grade 2
(mild), 48% of participants in the experimental group and 57% in the
control group were predicted to convert to surgery, while at

Table 5
Mean (SD) satisfaction scores at each assessment for each group, and mean between-group difference (95% CI) at each assessment.

Satisfaction score Groups Mean between-group difference

Week 6 Week 24 Week 6 Week 24

Exp Con Exp Con Exp minus Con Exp minus Con
(n = 45) (n = 49) (n = 49) (n = 48)
a
Combined satisfaction score (0 to 70) 43 31 44 33 13 11
(15) (11) (12) (12) (7 to 17) (6 to 16)

In the past week, how satisfied are you in your 5.6 5.2 5.5 4.8 0.4 0.7
a
ability to use your (randomised) hand? (0 to 10) (2.3) (2.2) (2.4) (2.3) (20.5 to 1.3) (20.2 to 1.7)
In the past 6 (24) weeks, how satisfied are you with 5.6 4.3 5.3 4.3 1.2 1.0
the changes (if any) to the symptoms in your (2.3) (2.0) (2.5) (2.3) (0.3 to 2.1) (0.7 to 2.0)
(randomised) hand? (0 to 10) a
I believe attending (this) Hospital for these 6.2 4.2 6.8 4.8 2.0 2.0
appointments has been beneficial to my condition. (2.3) (2.0) (2.1) (2.5) (1.1 to 2.9) (1.1 to 2.9)
(0 to 10) b
I feel less frustrated waiting for a medical 6.5 4.3 6.6 4.7 2.2 1.9
consultation since the CTS treatment started. (2.1) (2.0) (2.0) (2.6) (1.4 to 3.1) (1.0 to 2.9)
(0 to10) b
I feel less anxious waiting for a medical consultation 6.5 4.4 6.7 4.6 2.1 2.0
since the CTS treatment started. (0 to 10) b (2.2) (1.9) (2.0) (2.6) (1.3 to 2.9) (1.1 to 3.0)
I have confidence in managing my CTS symptoms 5.9 3.9 6.1 4.2 2.0 1.9
now. (0 to 10) b (2.0) (2.1) (2.1) (2.3) (1.2 to 2.8) (1.0 to 2.8)
How satisfied are you with the treatment you 7.4 4.4 7.4 5.6 3.0 1.8
received? (0 to 10) a (2.2) (2.4) (1.8) (2.9) (2.0 to 3.9) (0.9 to 2.8)

Con = control group, CTS = carpal tunnel syndrome, Exp = experimental group, Shaded row = primary outcome.
a
Higher scores indicate higher satisfaction.
b
Higher scores indicate stronger agreement.
102 Lewis et al: Non-surgical management of carpal tunnel syndrome

Table 6
Mean (SD) adjusted for baseline values for continuous outcomes at Weeks 0, 6 and 24 for each group, and adjusted between-group differences (95% CI).

Outcome Groups Adjusted between-group differencea

Week 0 Week 6 Week 24 Week 6 Week 24

Exp Con Exp Con Exp Con Exp minus Con Exp minus Con
(n = 52) (n = 53) (n = 47) (n = 49) (n = 49) (n = 48)

Symptom severity
BQSSS (1 to 5) 2.86 2.71 2.52b 2.83b 2.57 2.86b 20.31 20.29
(0.80) (0.69) (0.74) (0.71) (0.93) (0.94) (20.52 to 20.10) (20.56 to 20.03)
S-LANSS (0 to 24) 14 12 12 14 12c 13 22 21
(7) (6) (8) (8) (8) (8) (24 to 1) (24 to 1)
Functional limitation
BQFSS (1 to 5) 2.41c 2.08c 2.26b 2.39b 2.40 2.67 20.13 20.27
(0.92) (0.83) (0.80) (0.78) (0.99) (1.00) (20.36 to 0.11) (20.55 to 0.02)
DASH (1 to 100) 40 31 32b 40 36b 43 28 26
(22) (19) (19) (18) (23) (23) (213 to 23) (213 to 0)
PSFS (0 to 10)d 4.3e 5.0c 5.06b 4.23b 5.4e 4.2f 0.8 1.0
(1.8) (2.1) (1.50) (1.47) (2.3) (2.3) (0.4 to 1.3) (0.3 to 1.7)

Higher scores indicate increased severity except where noted. A score of  12 on the S-LANSS indicates pain of a predominantly neuropathic origin.
BQFSS = Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire, BQSSS = Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire, Con =
control group, DASH = Disability of the Arm, Shoulder and Hand, Exp = experimental group, PSFS = Patient-Specific Functional Scale, S-LANSS = self-completed version of the Leeds
Assessment of Neuropathic Symptoms and Signs.
a
Mean between-group difference adjusted for an individual’s baseline value by inclusion as a covariate in the regression analysis.
b
1 missing.
c
2 missing.
d
Higher scores indicate increasing function.
e
4 missing.
f
3 missing.

electrodiagnostic grade 3 (moderately severe) this was 57% of partici-
pants in the experimental group and 92% in the control group. At grade
5 (very severe), 100% of control group participants were predicted to
convert to surgery and 73% in the experimental group.
For the post-hoc long-term outcome, participants were followed-
up at an average of 180 weeks (range 108 to 248) after they
completed the trial. Of the participants in the experimental group
who were not recommended surgery at 24 weeks, 32% (7/22) even-
tually had surgery at an average of 52 weeks (range 20 to 92) after
completion of the trial. The other 68% (15/22) did not undergo sur-
gery. Of the participants in the control group who were not recom-
mended surgery and received the experimental intervention after
completion of the trial, 40% (4/10) had surgery at an average of 72
weeks (range 36 to 144) after completion of the trial.
Discussion
The main estimates generated by this study are that the therapist-
led program of education, splinting and home exercises: reduces the
likelihood of proceeding to surgery 24 weeks later by 21%; increases
the likelihood of patients reporting a successful improvement at 6
weeks by 15%; and improves the combined satisfaction score by just
over 10 points at both time points. These results should be viewed
alongside the confidence intervals associated with these primary
outcomes, which indicate important uncertainty around these point
estimates. Even without well-established thresholds for the smallest
worthwhile effect of the interventions on these outcome measures, it
seems reasonable to assume that the least favourable limits of these
confidence intervals would not be considered worthwhile, whereas
the most favourable limits seem to outweigh the inconveniences of
the intervention. Similarly, most secondary outcome measures fav-
oured the experimental intervention over the control group, with
most effect estimates being at or approaching clinically meaningful
effects. The secondary outcomes that showed such improvements
included several aspects of patient satisfaction, the Symptom Severity
Scale of the Boston Questionnaire, the DASH and the PSFS. Again,
however, the weaker effects at one end of the confidence interval
indicate that we cannot be sure that the average effect of the inter-
vention in the wider population of people waitlisted for CTS surgery
is clinically worthwhile on most of these secondary outcomes.
Although the estimates of benefits were too imprecise to confirm
that the effects are clinically worthwhile individually, there were
many such benefits: reduced conversion to surgery, more favourable
global rating of change, greater satisfaction scores, a lower symptom
severity score and improved ratings of function. Pooling even the
weakest estimate of each of the beneficial effects starts to amount to
a worthwhile intervention, particularly given the low cost of the
intervention to the healthcare system.
The estimate of the experimental intervention’s effect on the like-
lihood of symptoms occurring outside the median nerve territory and
therefore potentially representing central mechanisms26 was a
reduction of almost 20%. Although the confidence interval around this
estimate included small reductions and even no reduction, it did

Table 7
Number (%) of participants in each group, and risk difference (95% CI) between groups for symptom distributions, based on the descriptions of Katz.25

Symptom distribution Groups Risk difference (95% CI)

Week 0 Week 6 Week 24 Week 6 Week 24

Exp Con Exp Con Exp Con Exp minus Con Exp minus Con
(n = 51) (n = 53) (n = 46) (n = 49) (n = 49) (n = 48)

Presence of hand symptoms 37 37 26 37 27 35 20.19 20.18

outside median nerve (73) (70) (57) (76) (55) (73) (20.38 to 0.00) (20.37 to 0.01)
territory, n (%)
Presence of symptoms 21 21 13 16 16 18 20.04 20.05
proximal to wrist, n (%) (41) (40) (28) (33) (33) (38) (20.22 to 0.14) (20.24 to 0.14)

Minor inconsistencies in the table are due to the effects of rounding.

Con = control group, Exp = experimental group.
 Research
exclude any worsening effect, suggesting that the experimental inter-
vention may reduce (and does not increase to any important extent)
the likelihood of extra-median symptoms. The estimate of the exper-
imental intervention’s effect on the likelihood of symptoms occurring
proximal to the wrist was unclear, with the confidence intervals failing
to exclude important effects in either direction (Table 7).
The reduction in conversion to surgery observed in the current
study is in line with two retrospective cohort studies, which reported
a 22% to 46% reduction in need for CTS surgery following conservative
management.8,10 One randomised controlled trial investigated the
response to therapeutic interventions in CTS patients referred for
surgical opinion.20 Although the outcomes were similar in demon-
strating a reduced desire to pursue surgery, diminished symptoms
and improved function and patient satisfaction,20 risk of bias was
high and only a small sample was included.
Currently available data suggest that waiting time for CTS surgery
exceeds 5 months in many developed countries. In the UK National
Health Service, for instance, the mean waiting times in the Greater
London area for 2018 exceeded 5 months (range 3.3 to 9.8 months).4
In lower socioeconomic areas (eg, Jaywick), average wait times were
longer: 7 months (range 5.3 to 11.0 months).4 The reduction in con-
version to surgery with the experimental intervention in the current
study should be of interest to policymakers and developers of clinical
guidelines, given the expected doubling in demand for CTS surgery by
2030 and the associated logistical and financial strain on public
health systems.6 The experimental intervention was designed to
achieve efficiency whilst minimising costs. Our group session fol-
lowed by a home program is likely more cost-effective than previ-
ously published pre-surgical management pathways involving one or
more one-on-one sessions.8,10,20 In addition to potential savings, the
reduction in surgical waitlist will accelerate access to operative care
for those patients who require surgery, thereby reducing associated
resource utilisation and disability.
The effect sizes for hand symptoms and function were small,
which was also reflected in the small or non-significant changes in
related dimensions in the patient satisfaction questionnaire. Despite
this, there was a 21% lower conversion to surgery among the partic-
ipants in the current study. This suggests that the experimental
intervention may be particularly beneficial in some patients but not
others, resulting in the small effects observed at group level. Never-
theless, those in the experimental group were 15% more likely to
report feeling at least ‘a good deal better’ at Week 6 and 14% more
likely at Week 24, which is in line with other satisfaction dimensions
(eg, frustration, anxiety and confidence). It could thus be speculated
that the beneficial effect of the experimental intervention is attrib-
uted to a reduction in patients’ frustration and anxiety, and an in-
crease in their confidence in managing symptoms. Limited health
literacy27 and inadequate access to conservative care28 are common
issues for patients with CTS. Future work comparing the experimental
intervention with an intervention containing mock splinting and
exercises may shed light on the contribution of the various compo-
nents of the experimental intervention.
In current CTS treatment guidelines, a bout of conservative man-
agement is optional but not compulsory before surgery is consid-
ered.29 Nevertheless, the uptake of non-operative modalities seems
suboptimal, with , 23% of patients receiving splints in a UK setting.28
The experimental intervention in the present study incorporated
education and splinting, which are part of current treatment guide-
lines and can readily be administered by a hand therapist. Steroid
injections are also commonly recommended as a conservative treat-
ment modality for CTS. A recent study showed that steroid injections
result in superior symptom relief compared with night splinting at 6
weeks; however, the outcomes at 24 weeks seemed comparable.30 It
remains to be examined whether the addition of steroid injections to
the present study’s experimental intervention further decreases the
need for surgery. The experimental intervention also included nerve
and tendon gliding exercises, which form part of the Royal College of
Surgeons of England CTS treatment recommendations.29 A systematic
review suggested that there is limited evidence that adding nerve and
103
tendon gliding exercises to splinting is superior to splinting alone.14
Since the publication of that review, several trials have found effi-
cacy of these exercises over other forms of conservative in-
terventions16 and comparable clinical benefit to surgery.15
Several limitations need to be considered when interpreting the
present study. Recruitment was stopped early due to staffing and
changes in models of care (including implementation of the experi-
mental intervention) reducing waitlists at the trial sites. Although our
sample was large enough to detect statistical significance, the
curtailment of recruitment reduced the precision of estimates. Another
limitation was that fewer patients with severe electrodiagnostic
findings were enrolled than was expected, precluding the planned
two-strata analysis of electrodiagnostic test severity. However, the
post-hoc analysis found that the need for surgery was reduced in the
experimental group, even in participants with greater severity on
electrodiagnostic testing. Future work is needed to further explore this,
as surgery remains the recommended treatment for patients with
severe CTS.29 The protocol was also varied to include participants with
diabetes, who are commonly excluded from conservative CTS man-
agement trials.31 Conversion to surgery was high for participants with
severe CTS and all participants with diabetes converted to surgery. The
inclusion of these participants may have decreased the ability to detect
an effect in less-severely affected participants but it did enable an ef-
fect to be shown in more severely affected participants.
Ethical requirements meant that treatment could not be withheld
for . 24 weeks, at which time the experimental intervention was
offered to participants who had been in the control group. It has
previously been reported that a large proportion of patients who are
treated with splinting alone may eventually require surgery.31 Of note
though, a carefully designed trial suggested that a large proportion of
patients converted to surgery within 24 weeks (31%),32 when the
experimental intervention in the present study still reduced the need
for surgery. Our post-hoc long-term analysis suggests that whereas
some participants did require surgery, the majority (73%) of partici-
pants who were not recommended surgery at the completion of the
trial continued to avoid surgery for an average follow-up of almost 4
years. However, the lack of an untreated control group for comparison
in this post-hoc long-term analysis mandates future studies with
follow-ups over several years to conclusively determine whether the
experimental intervention avoids rather than delays surgery.
In summary, a combination of education, night splinting and
home exercises has benefits over remaining on the waiting list for
surgery with no other intervention. It resulted in a 21% reduction in
conversion to surgery, with a 15% greater perceived improvement and
a 12% higher satisfaction at 6-weeks follow-up. The uncertainty
around these point estimates makes it unclear whether these benefits
are worthwhile and this is likely to vary within the clinical context.
With this in mind, clinicians should discuss these results with each
individual patient, who can weigh-up the uncertainly in the effect of
experimental intervention against known costs, time commitment
and risks to decide if they will embark on the therapy. Given the
predicted increase in CTS surgery and associated costs, this simple
and cost-effective care pathway warrants consideration.
What was already known on this topic: Carpal tunnel
syndrome can cause pain, paraesthesia and sometimes weak-
ness, typically in the median nerve distribution. Surgical
decompression of carpal tunnel syndrome brings long-term
improvement but waiting times for the procedure in the public
healthcare system are typically long.
What this study adds: In people awaiting carpal tunnel sur-
gery, a combination of education, night splinting and home ex-
ercises reduced progression to surgery and increased perceived
improvement and satisfaction. Uncertainty about the magnitude
of these benefits in the wider population of people awaiting
carpal tunnel surgery means that individual patients will need to
decide whether the anticipated benefits make undertaking the
intervention worthwhile.
104 Lewis et al: Non-surgical management of carpal tunnel syndrome
Footnotes: a Stata 14.2, College Station, Texas, USA.
eAddenda: Appendices 1 to 3, Box 1, and Tables 1, 2 and 8 can be
found online at https://doi.org/10.1016/j.jphys.2020.03.007.
Ethics approval: The Metro South Human Research Ethics Com-
mittee approved this study (HREC/13/QPAH/434). All participants
gave written informed consent before data collection began.
Competing interest: The authors have no competing interest.
Sources of support: This work was supported by a Health Practi-
tioner Stimulus Grant from Queensland Health and a Small Project
Investment Grant of the Private Practice Trust Fund (PPTF) of Gold
Coast Hospital and Health Service. ABS is supported by the National
Institute for Health Research (NIHR) Biomedical Research Centre
(BRC) Oxford. The views expressed are those of the authors and not
necessarily those of the NHS, the NIHR or the Department of Health.
The funders had no role in the study design, data collection, analysis
and interpretation of data as well as in the writing of the report and
the decision to submit the article for publication.
Acknowledgements: The authors would like to thank all partici-
pants as well as the clinicians involved in this trial.
Provenance: Not invited. Peer reviewed.
Correspondence: Annina B Schmid, Nuffield Department of Clin-
ical Neurosciences, Oxford University, UK. Email:
annina.schmid@neuro-research.ch
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Websites
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