We aim to investigate the amount of patients who have lasting benefit from such surgery, and which proportion eventually get recurrent symptoms. We are going to investigate the cohort which has previously been studied by our group (protocol Dr.…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We examine the amount that CTS symptoms have changed over the years on the
basis of Symptom Severity Score (SSS) and the Functional Status Score (FSS),
commonly known as the Boston Carpal Tunnel Questionnaire (BCTQ). In addition,
we compare the NCS characteristics and the cross-sectional area (CSA) in some
patients.
Secondary outcome
NCS characteristics (nerve conduction velocity, latency times, distal motor
latency)
Cross-sectional area, measured by using the ellips method and the continuous
trace method.
Background summary
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and
causes complaints such as paresthesias in the area of the median nerve, pain
and loss of strength in the hand. Diagnosis is based on clinical features and
can be confirmed by nerve conduction studies (NCS) and Ultrasonography (US).
Pregnancy is one of the major risk factors. If the diagnosis is made, patients
may undergo a surgical procedure in which a release of the median nerve at the
carpal tunnel takes place. Little is known about long term effects of this
treatment due to lack of adequate follow-up of these patients after surgery.
Study objective
We aim to investigate the amount of patients who have lasting benefit from such
surgery, and which proportion eventually get recurrent symptoms. We are going
to investigate the cohort which has previously been studied by our group
(protocol Dr. Claes F). In addition, we study the NCS characteristics to find
out if they are predictive for success or failure of surgery, so that we can
identify those patients, who will be expected to benefit from an intervention.
Patients who have recurrent symptoms, will be subjected to another NCS and US
in order to compare it with the pre-operative findings, to identify predictors
for recurrence of symptoms. Some of the patients that have been operated
successfully will be asked as control. Besides, we would like study patients
with CTS during a previous pregnancy, for recurrent symptoms after birth and
for the necessity of surgery.
Study design
Prospective cohort study
Study burden and risks
Using non-invasive and non-painful procedures, we attempt to find out if we
are able to predict outcome after a median nerve release in patients with CTS.
In addition, we will investigate the profit of a shorter NCS procedure, which
could be possible if a certain value is very predictive for recovery or even no
recovery after surgery.
The advantage could be that this non-invasive -but for some people annoying-
NCS could be reduced in the future as well as that we can discourage surgery in
patients in which we know in advance that the recovery won't be sufficiently.
In addition, we hope find evidence to the natural course of a CTS. Moreover, we
want to figure out whether we have to treat patients with carpal tunnel
syndrome during pregnancy, or that the symptoms after a pregnancy will
disappear again.
In conclusion: There is a low risk (no side effects, no invasive procedure and
low load for the patient (only one hospital visit), and once completing
questionnaires during 5a 10 minutes. There are no further precepts or
restrictions.
Weg door Jonkerbos 100
Nijmegen 6532 SZ
NL
Weg door Jonkerbos 100
Nijmegen 6532 SZ
NL
Listed location countries
Age
Inclusion criteria
All patients who fulfilled CTS criteria mentioned below*. Also patients who indicate that the fifth finger is also involved.;* patients with pain and/or paresthesia in and restricted to the sensory distribution of the median nerve for at least 3 months, and if patients met 2 or more of the following criteria: (1) nocturnal pares- thesias, (2) reproduction or aggravation of paresthesias or pain by provocative tests (Tinel or Phalen*s sign), (3) aggravation of paresthesias by activities such as car driv- ing, bicycling, holding a book, or holding a telephone, and (4) relieve of symptoms by shaking the hand (Flick sign)
Exclusion criteria
clinical signs of polyneuropathy or known hereditary polyneuropathy, history of hand trauma,previous surgery for CTS, every atrophy of m. pollicis breves, history of rheumatoid arthritis, arthritis of the wrist, diabetes mellitus, hypothyroidism or hyperthyroidism, alcoholism.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59236.091.16 |