J Neurol (2017) 264:2394–2400

DOI 10.1007/s00415-017-8637-2

ORIGINAL COMMUNICATION

Treatment outcome in patients with clinically defined carpal

tunnel syndrome but normal electrodiagnostic test results:
a randomized controlled trial
Floriaan G. C. M. De Kleermaeker1 · Jan Meulstee1 · Franka Claes2 ·
Kristel M. Kasius3 · Wim I. M. Verhagen1 

Received: 25 June 2017 / Revised: 1 September 2017 / Accepted: 2 October 2017 / Published online: 9 October 2017
© Springer-Verlag GmbH Germany 2017

Abstract  Little is known about treatment effect of car- Introduction

pal tunnel release in patients with clinically defined car-
pal tunnel syndrome (CTS), but normal electrodiagnostic Carpal tunnel syndrome (CTS) is the most common entrap-
test results (EDX). The aim of this study was to determine ment neuropathy [1]. In clinical practice the diagnosis of
whether this category of patients will benefit from surgical CTS is based on typical symptoms such as nocturnal pain,
treatment. 57 patients with clinically defined CTS and nor- burning sensations, paresthesias and numbness in the terri-
mal EDX were randomized for surgical treatment (n = 39) tory innervated by the median nerve [2]. Surgical decom-
or non-surgical treatment (n = 18). A six-point scale for pression of the median nerve is the most robust treatment for
perceived improvement as well as the Boston Carpal Tunnel CTS, with a success rate between 75 and 90% [3]. Improve-
Questionnaire was completed at baseline and at follow-up ment after a corticosteroid injection in the carpal tunnel, is
after 6 months. A significant improvement of complaints reported in 77% of the patients at 1 month follow-up, but in
was reported by 70.0% of the surgically treated patients 50% [4] of them a second treatment is needed after 1 year.
and 39.4% reported full recovery 6 months after surgery. There are no differences in treatment effect between a local
Furthermore, both Functional Status Score and Symptom corticosteroid injection and a nocturnal splint [5].
Severity Score improved significantly more in the surgically Electrodiagnostic tests (EDX) are often performed to
treated group (p = 0.036 and p < 0.001, respectively). This confirm the clinical diagnosis and to determine the extent
study demonstrates that most patients with clinically defined of EDX abnormalities. In clinically defined CTS a sensitiv-
CTS and normal EDX results will benefit from carpal tun- ity of approximately 85–90% and a specificity of 85% have
nel release. Therefore, this group of CTS patients must not been reported. This means that, 15% of these patients show
a priori be refrained from surgery. normal EDX results [6]; one study reported even 25% [7].
Surprisingly, few robust data are published about the treat-
Keywords  Carpal tunnel syndrome · Treatment · ment effect in these patients. Some studies demonstrated
Outcome · Negative · Electrodiagnostic tests · clinical improvement in this group of patients after decom-
Electroneurography pressive surgery and it has therefore been suggested that
these patients should not be refrained from decompressive
surgery [8–10]. In contrast, however, Bland et al. empha-
* Floriaan G. C. M. De Kleermaeker sized the necessity for NCS, as they found statistically signif-
[email protected] icant better results of decompressive surgery in CTS patients
1
Department of Neurology, Canisius Wilhelmina
with abnormal EDX, compared to patients with normal EDX
Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, results [11].
The Netherlands The aim of this study was to determine whether patients
2
Department of Neurology, Franciscus Vlietland, with clinically defined CTS but normal EDX, benefit from
Vlietlandplein 2, 3118 JH Schiedam, The Netherlands surgical treatment.
3
Department of Neurology, Onze Lieve Vrouwe Gasthuis, Jan
Tooropstraat 164, 1061 AE Amsterdam, The Netherlands

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J Neurol (2017) 264:2394–2400 2395

Methods performed by an experienced neurophysiologist who was

blinded for clinical data [13, 14]. These tests were performed
Patients with a Viking myograph type IV (Nicolet Biomedical, Mad-
ison, WI, USA). Skin temperature was maintained above
Patients with complaints suggestive of CTS were referred to 31 °C by applying hot packs [15]. To consider EDX consist-
our outpatient clinic by their general practitioners. Patients ent with CTS, a minimum of two tests had to be abnormal.
were prospectively enrolled into the study if they com- In summary, three different types of sensory tests were
plained about pain and/or paresthesias in and restricted to performed. The first test (DIG-4 test) compares the distal
the territory innervated by the median nerve and if they ful- sensory latency (DSL) of the median nerve and the ulnar
filled two or more of the following clinical CTS criteria: (1) nerve over the same conduction distance, recording from
nocturnal paresthesias, (2) aggravation of paresthesias by digit 4 by ring electrodes. Difference in DSL of more than
activities such as driving a car, riding a bike, holding a book 0.4 ms [according to our laboratory’s reference values the
or holding a telephone, (3) paresthesias relieved by shak- upper limit of normal (ULN)] or absence of a median SNAP
ing the hand (positive Flick sign). These criteria have been was considered to be abnormal and supporting CTS.
adopted from a previously performed study [7]. In the second test (DIG-1 test), the difference in DSL is
Exclusion criteria were defined as: age under 18, signifi- determined between median nerve and radial nerve over an
cant language barrier, history or clinical signs of polyneu- identical distance, recorded from the thumb. A DSL dif-
ropathy or known HNLPP (hereditary neuropathy with lia- ference of more than 0.6 ms (according to our laboratory’s
bility to pressure palsies), previous trauma or surgery to the reference values the ULN) or absence of median SNAP was
wrist, history of rheumatoid arthritis, diabetes mellitus, thy- considered to be abnormal and supporting CTS.
roid disease, alcoholism, arthrosis of the wrist, pregnancy, or The third sensory test (PALM-test [13]), is performed by
severe atrophy of the abductor pollicis brevis muscle. stimulation of the palm, wrist and the elbow while recording
Patients with normal EDX (i.e. no or only one abnormal SNAPS by ring electrodes from digits 2 and 3. Differences
test result) were selected for this study. Informed consent in sensory nerve conduction were calculated for the digit-
was obtained from each individual. Permission from the to-palm, palm-to-wrist and wrist-to-elbow segment. A delay
local Medical Ethics Committee was obtained. in conduction velocity in the palm-to-wrist segment relative
to the distal segment greater than 10 m/s or to the proximal
Clinical examination segment greater than 16 m/s was considered to be abnormal
and consistent with CTS.
A complete neurological clinical examination was per- The median distal motor latency (DML) was recorded
formed by an experienced examiner (wv). Sensory testing from the APB muscle after stimulation at a standardized
was performed with a monofilament (10 g) and two-point distance of 60 mm. A DML exceeding 4.0 ms (according to
discrimination. Strength of the abductor pollicis brevis our laboratory’s reference values the ULN) was considered
(APB) and opponens pollicis muscles was assessed using to be abnormal and consistent with CTS.
the MRC (Medical Research Council) scale. Besides, grip Reference values of ULN for these tests were derived
strength was determined using a Martin Vigorimeter and from a control group of 47 healthy, asymptomatic volunteers
classified as normal or abnormal [12]. Thenar atrophy was tested in our department [16].
classified as absent, mild or severe.
Treatment
Questionnaires
Patients were assigned by chance using opaque sealed enve-
At 6 months follow-up patients rated their perceived treat- lopes to surgical decompression or non-surgical treatment, in
ment effect on a six-point scale (1 = completely asympto- a ratio of 2:1. Patients randomized for non-surgical treatment
matic; 6 = aggravation of symptoms). Besides, they com- were offered a nocturnal wrist splint or a local corticoid
pleted the widely used and validated Boston Carpal Tunnel injection. Surgery was performed by well-experienced neu-
Questionnaire (BCTQ), consisting of the Symptom Severity rosurgeons under local anaesthesia with an open procedure.
Score (SSS) and Functional Status Score (FSS) at baseline
and approximately 6 months after treatment. Statistics

Electrodiagnostic testing All statistical analyses were performed using SPSS Statis-
tics 24.0. Differences in SSS and FSS after follow-up were
All patients underwent standardized motor and sensory NCS performed with a paired t test in case of nominal distribu-
in the symptomatic hand as described in previous studies, tion, and the Wilcoxon signed rank test for non-nominal

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distribution. Comparison in baseline characteristics and before inclusion was 12 months. There were no significant
outcome between the surgically treated patients and non- differences at baseline in sex, age, BMI, duration of symp-
surgically treated patients were performed with a Chi-square toms, included wrist, atrophy or weakness of abductor pol-
test for categorial variables. For continuous variables, the licis brevis muscle, weakness of opponens pollicis muscle,
unpaired t test was applied in case of nominal distribution disturbed sensibility tests or occurrence of Tinel or Phalen
and the Mann–Whitney test in case of non-nominal distribu- sign between the surgically treated group and conservatively
tion. p < 0.05 was considered as statistically significant. Cal- treated group.
culation of sample size was performed using G*Power 3.1.
In previous studies, improvement of symptoms after surgery Electrodiagnostic tests
is reported to be about 80% and after no treatment at all 22%
[16, 17]. The latter will be an underestimation, because in None of the included patients fulfilled EDX results consist-
our study some patients will be treated by a nocturnal wrist ent with CTS. 21.1% (12/57) of the patients had one abnor-
splint or corticosteroid injection. Therefore, for this power mal test, most often the PALM-test (Table 2).
calculation we used an estimate of 35%. To have a level of
statistical significance 5% and a power of 80%, 26 patients Treatment
are needed in the surgically treated group and 13 patients in
the non-surgically treated group. 39 out of 57 (68.4%) patients were treated surgically.
18 (31.6%) patients were treated non-surgically. Of the

Results
Table 2  Electrodiagnostic test results
Patients Electrodiagnostic test N Abnormal test

DIG1-test 57 2 (3.5%)
A total of 57 patients who met the criteria for clinically
DIG4-test 57 4 (7.0%)
defined CTS with normal EDX were included in this study.
PALM-test 57 5 (8.8%)
The clinical characteristics of these patients are shown in
DML 57 1 (1.8%)
Table 1. Of the studied population, 84% were women. Mean
age was 42.67 ± 11.11 years. Median duration of symptoms DML distal motor latency

Table 1  Baseline Characteristic Surgery Non-surgery p

characteristics
Na N

Sex (female) 39 32 (82.1%) 18 16 (88.9%) 0.51

Age (years) 39 43.6 ± 11.8 18 40.56 ± 9.33 0.34
Range 19–67 Range 22–60
BMI 39 27.0 ± 5.2 18 24.99 ± 3.31 0.24
Median duration of symptoms (months) 39 12 18 8
Mean duration of symptoms (months) 39 33.6 ± 48.72 18 13.11 ± 11.91 0.19
Range 3–192 Range 2–36
Wrist included (right) 39 19 (48.7%) 18 13 (72.2%) 0.23
Atrophy of abductor pollicis brevis muscle 38 1 (2.6%) 18 0 (0.0%) 0.49
Weakness
 Abductor pollicis brevis muscle 37 4 (10.8%) 18 2 (11.1%) 0.97
 Opponens pollicis muscle 37 2 (5.4%) 18 1 (5.2%) 0.98
Disturbed sensibility
 Two-point discrimination 37 31 (83.8%) 18 13 (72.2%) 0.32
 Monofilament 37 17 (45.90%) 18 8 (44.4%) 0.92
 Tinel positive 38 24 (63.2%) 18 13 (72.2%) 0.50
 Phalen positive 38 28 (73.7%) 18 13 (72.2%) 0.91

Surgery patients with clinically defined CTS who underwent surgical treatment, Non-surgery patients with
clinically defined CTS who underwent non-surgical treatment, BMI body mass index
a
 Number of patients may vary due to missing values

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J Neurol (2017) 264:2394–2400 2397

non-surgically treated patients, 4 (22.2%) were given a local Table 3  Subjective outcome after surgical treatment versus non-sur-
corticosteroid injection and 6 (33.3%) received a nocturnal gical treatment
splint. Outcome Surgery Non-surgery p
N Percentage N Percentage
Outcome
Important improve- 23/33 70.0 6/17 35.3 0.020*
43 out of 57 patients (75.4%) completed a follow-up. ment
27 (62.8%) were in the surgically treated group and 16 Completely asymp- 13/33 39.4 0/17 0 0.003*
tomatic
(37.2%) in the non-surgically treated group. At follow-up
Deterioration 2/33 6.1 3/17 17.6 0.152
after 6 months, an important improvement of complaints
as experienced by the patients (defined as “I still occasion- Surgery patients with clinically defined CTS who underwent surgi-
ally have complaints”, “I still rarely have complaints” or cal treatment, Non-surgery patients with clinically defined CTS who
underwent non-surgical treatment
“I am completely asymptomatic”) was reported by 70.0%
of the surgically treated group on a six-point scale (Fig. 1; * Statistically significant difference
Table 3). Besides, 39.4% reported full recovery (defined
as “I am completely asymptomatic”) after 6 months. The deterioration of complaints at follow-up versus 3 (17.6%) in
conservatively treated patients reported statistically signifi- the conservatively treated group (p = 0.152). Deterioration
cant worse outcomes. None of the conservatively treated was caused by complex regional pain syndrome (CRPS) in
patients reported a full recovery and only 35.3% reported one of the operated patients.
a significant improvement (p = 0.003 and p = 0.02). Of The surgically treated patients reported a statistical sig-
the surgically treated patients, two patients (6.1%) noticed nificant improvement in SSS and a marginally non-statistical

100

*
90
*
80

70

60

n.s.
Percent

50

40

30

20

10

0
Surgical treatment Non-surgical treatment

Full recovery Important improvement Deterioraon

* statistically significant difference

n.s. non significant

Fig. 1  Subjective outcome after surgical treatment versus non-surgical treatment

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significant improvement in FSS (Table 4). The conserva- be normal. Out of these patients, 14 (88%) reported improve-
tively treated group did not report statistical significant dif- ment after surgery. Complaints were evaluated by applying
ferences in SSS and FSS. In comparison to the conserva- visual analogue scale (VAS). The postoperative values did
tively treated patients, the surgically treated patients had a not differ statistically in the group with normal EDX results
significant improvement in both SSS and FSS (p = 0.001 compared to patients with abnormal EDX results [10]. Even
and p = 0.036). better results were reported by Lama. Eight patients (total of
10 hands) with normal EDX results underwent carpal tunnel
release. All of them believed to perceive improvement of
Discussion complaints. Treatment effect was evaluated using the BCTQ.
No differences were found between patients with or without
In a previous study, we reported, that, in the Netherlands, the abnormal EDX results [19]. Unfortunately, exact differences
majority of neurosurgeons and orthopaedic surgeons rarely in BCTQ before and after treatment are not reported.
operate clinically defined CTS patients without a prior elec- Similar results were found by Grundberg et al., Louis
trodiagnostic confirmation [18]. In addition, other studies et al. and Concannon et al. These studies, however, were
suggest that EDX results may predict the outcome of surgi- conducted retrospectively lacking valid and reliable out-
cal decompression and also, that EDX results may prove come measures [8, 9, 20]. Zyluk et al. studied 93 patients
to be useful in case patients need treatment if they do not with clinically defined CTS who underwent carpal tunnel
improve after surgery [11]. release. About half of the patients (n = 45) had positive
In the current study, we demonstrated a significant reduc- EDX preoperatively. The other half was operated without
tion of complaints after carpal tunnel release in patients with having undergone any electrodiagnostic tests at all. Both
clinically defined CTS but normal EDX results. A total of groups reported improvement of SSS and FSS, as well as
70% perceived an important reduction in complaints and VAS and some other parameters [21]. However, baseline
almost 40% reported a full recovery after surgery, which was FSS and SSS were significantly lower in the electrodiag-
significantly more than in the non-surgically treated group. nostically confirmed group. Unknown is to what extent the
In the latter, none of the patients reported to be completely group without EDX actually had no abnormalities in nerve
asymptomatic and only 35% reported a reduction of com- conduction of the median nerve.
plaints. Moreover, there was a statistically significant reduc- Compared to the outcome of patients with abnormal
tion in SSS 6 months after surgery, and a non-significant EDX, CTS patients without EDX abnormalities seem to have
reduction in FSS. This was significantly better than in the a less favourable outcome in this regard. Claes et al. stud-
non-surgically treated patients, in which there was no sta- ied 89 patients with clinically defined CTS and abnormal
tistically significant reduction in FSS and SSS at follow-up. EDX. They demonstrated a mean improvement in SSS of
Previously reported studies showed similar results. Finsen 1.36 ± 0.82 and FSS of 0.68 ± 0.84. Baseline SSS and FSS
et al. mentioned a favourable outcome in 88% of the surgi- were comparable to our patients. Moreover, in this group
cally treated patients. In their study, 68 patients underwent 60.6% reported full recovery after 7–9 months [16]. In other
an open carpal tunnel release. Preoperatively they all under- studies, improvement in FSS and SSS was found to the same
went EDX, but these results were not assessed until the end extent or even more [22, 23]. A possible reason for the less
of the study. In 16 (23%) patients, EDX results appeared to favourable results in surgically treated patients with normal

Table 4  Outcome SSS and FSS SSS p FSS p

N Mean ± SD N Mean ± SD

Surgery
 At inclusion 27 2.95 ± 0.64 27 2.19 ± 0.72
 At follow-up 27 1.86 ± 0.95 27 1.80 ± 0.89
 Difference 27 − 1.09 ± 1.11 < 0.001* 27 − 0.39 ± 1.02 0.055
Non-surgery
 At inclusion 16 2.88 ± 0.66 16 2.08 ± 0.50
 At follow-up 16 2.69 ± 0.84 16 2.31 ± 0.94
 Difference 16 − 0.19 ± 0.48 0.130 16 0.23 ± 0.70 0.380
p 0.001* 0.036*

SSS Symptom Severity Score, FSS Functional Status Score

* Statistically significant difference

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EDX results may be the presence of patients with CTS mim- be influenced by a placebo effect. The extent of placebo
ics as cause of their complaints. Obviously, these patients effect in carpal tunnel release is unknown. Sham surgery
are less likely to respond to surgical treatment. Lama et al. can be considered in future trials to eliminate this factor,
found other causes of symptoms in 5 of the 25 studied cases. but this seems unethical. Moreover, response rate was not
These included cervical root compression, thoracic outlet maximal. 75% of the patients completed all questionnaires.
syndrome and rheumatoid arthritis [19]. In our study, we Response rates of the six-point scale were higher, because
selected only those patients who strictly fulfilled the clini- this questionnaire was taken by telephone interviews in
cal criteria for CTS. If there was any suspicion of another patients who did not respond initially. Additionally, the
underlying cause by clinical history or neurological exami- number of patients is not very high; however, power
nation, patients were not included in this study. Therefore, was enough to investigate reliable differences in treat-
in our opinion, additional diagnostics have no added value ment effect. Moreover, to our knowledge, this is the first
in this study. and largest randomized controlled trial (RCT) in which
In general, open carpal tunnel release has a very low com- patients without abnormal EDX results underwent carpal
plication risk. Different studies report about a complication tunnel release. Furthermore, our results are in accordance
risk of 0.5%, consisting of nerve injury, postoperative pain with previously reported results.
and infection. In this study, one patient developed CRPS In conclusion, this study demonstrates that most patients
after surgery. Other complications are not reported, since with clinically defined CTS and normal EDX results will
this was not the aim of the study. benefit from carpal tunnel release. Therefore, this group of
The surgically treated patients in this study reported an CTS patients must not a priori be refrained from surgery.
improvement of 1.09 in SSS and 0.39 in FSS, both statisti-
cally significant. The clinical importance of improvement in Acknowledgements  This research received no funding.
BCTQ is still being discussed. In the past, some studies were Compliance with ethical standards 
performed to determine the minimal clinically important dif-
ference (MCID) of the BCTQ. MCID is the smallest differ- Conflicts of interest  On behalf of all authors, the corresponding au-
ence in score of an outcome instrument that patients perceive thor states that there is no conflict of interest.
as important. Cut-off values for SSS have been published
in a wide range of 0.8–1.45 and 0.5–1.6 for FSS [24–26]. Ethical standards  The study was approved by the local ethics com-
mittee and was performed in accordance with the ethical standards
Therefore, in our opinion, the clinical applicability of the laid down in the 1964 Declaration of Helsinki. Informed consent was
MCID is currently insufficient. obtained from each individual prior to their inclusion in this study.
Ultrasonography (US) in carpal tunnel syndrome with-
out abnormal EDX is controversial. One study published
by Rahmani et al. suggests that US is a contributive tool in
suspected carpal tunnel syndrome without abnormal EDX
results. They found that high cross-sectional area (CSA),
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