A: The purpose of the current trial is to investigate what is the best treatment for patients with clinical definite CTS and normal nerve conduction studies and to see what is the value of ultrasonography in this specific group of patients.B: The…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A: Primairy outcome measure: the percentage of patients with no complaints
after 6 months.
B: Primairy outcome measure: the percentage of patients with clinical definite
and probable CTS with ultrasonography meeting the criteria of CTS.
Secondary outcome
A: Secundairy outcome measures:
1. The percentage of patients with an improvement of the Functional Status
Score with 40 % or more after 6 months.
2. The percentage of patients in group 2 who are operated on after 6 months.
3. The percentage of patients in group 1 with persistent complaints of CTS.
4. The percentage of patients with ultrasonography meeting the criteria of CTS.
B: Secundairy outcome measure:
The correlation between nerve conduction studies and ultrasonography in
patients with clinical definite and probable CTS.
Background summary
A: The carpal tunnel syndrome is a common entrapment neuropathy and is an
important cause of functional disability. Depending on the severity of
complaints a conservative or surgical treatment is chosen. 8 To 13 % of
patients have a normal electrodiagnostic investigation. There is no consensus
about the treatment in this specific group of patients. Because of this,
treatment varies with different neurologists of neurosurgeons. Ultrasonography
of nerves has improved significantly in the last few years.
B: The carpal tunnel syndrome is a common entrapment neuropathy and is an
important cause of functional disability. Depending on the severity of
complaints a conservative or surgical treatment is chosen. In nearly all
patients an elctrodiagnostic examination is done to confirm the diagnosis. In
many patients however, the complaints are very clear and in these cases the
question rises if such an examination is really necessary. In the past few
years the technique of ultrasonography of nerves has been extensively improved
and can possibly replace an electrodiagnostic examination in the future.
Study objective
A: The purpose of the current trial is to investigate what is the best
treatment for patients with clinical definite CTS and normal nerve conduction
studies and to see what is the value of ultrasonography in this specific group
of patients.
B: The purpose of this trial is to investigate the value of sonography in
patients with clinical definite or probable CTS.
Study design
A: Patients with clinical definite CTS, who meet the inclusion- and
exclusioncriteria, with normal nerve conductionstudies are randomised into two
groups. Group 1 will be treated surgically, group 2 will treated
conservatively. Because of the expected higher succesrate in the surgically
treated group, there will be 2 patients included in the surgery group for every
patient in the conservative group. After 6 months there wil be a clinical
follow up and the results are compared, with the primary outcome being the
percentage of patients with no complaints. Also the percentage of positive
sonography examination will be determined.
B: Patients will be devided into two groups according to clear clinical
criteria: group 1 with clinical definite CTS and group 2 with clinical probable
CTS. All patients undergo a standardised nerve conduction study and
ultrasonography of the carpal tunnel, measuring the crossectional area of the
median nerve. The treatment will be determined by the patients own neurologist
in agreement with the patient.
Intervention
A: Patients in group 1 will be treated surgically with open release of the
carpal tunnel. The operation is carried out by a neurosurgeon. Patients in
group 2 are treated conservatively.
B: There is no specific intervention because of this trial. Patients will be
treated by their own neurologist as in daily clinical practice.
Study burden and risks
A: Patients undergo a non-invasive ultrasonography of the carpal tunnel. There
are strict clinical criteria to prevent patients being operated unnecessary.
Follow up studies have indicated that up to a third of patients with a CTS can
improve spontaneously after a follow up of maximum 11 years. With this in mind
a wait and see policy during 6 months is justified.
B: Patients undergo a non-invasive ultrasonography of the carpal tunnel, next
to a nerve conduction study which is carried out always in daily clinical
practice. There are no risks involved with the ultrasonography examination. The
examinations will be carried out on the same day as much as possible. Patients
are seen in follow up after 6 months in the neurology outpatient department.
Weg door Jonkerbos 100
6525 SZ Nijmegen
Nederland
Weg door Jonkerbos 100
6525 SZ Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Paresthesia or pain in de area supplied by median nerve, with at least 2 of the following: nocturnal complaints, improvement by Flick's sign, worsening with handmovements.
Normal electrodiagnostic investigation of the median nerve.
Exclusion criteria
Clinical polyneuropathy, Trauma, bad general condition with reduced life expectancy, severe atrophy of m. Abductor pollicis brevis, pregnancy, alcoholism,
arthritis of arthrosis, known diabetes mellitus, reumatoid arthritis, thyroid pathology, HNLPP, languagebarrier, psychiatric problem, other neurological problems in arm, former surgery, refusal surgery, age younger than 18, participance in other trials
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 | NL11391.091.06 |