To clarify the aetiology of CTS and prognostic factors for the development of CTS.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Joint stiffness, skin stiffness
Secondary outcome
Physical activities, body water.
Background summary
The exact aetiology of CTS remains yet unknown. A rise in carpal tunnel
pressure is well documented, but why this phenomenon occurs is yet unknown in
most patients. There is an absolute or relative narrowing of the carpal tunnel,
which results in a compression of the median nerve.
A relation between connective tissue composition and joint stiffness is proven.
Possibly this relationship extends to a relation between connective tissue
composition, joint stiffness and the prevalence of CTS. We postulate, that a
stiffer flexor retinaculum (roof of carpal tunnel) will be less compliant. As a
consequence of this stiffer retinaculum the pressure in the carpal tunnel will
rise more quickly in stiff patients resulting in CTS-complaints.
In answering this question we will measure the stiffness of the skin and joints
in patients with and compare these results with patients without CTS.
Study objective
To clarify the aetiology of CTS and prognostic factors for the development of
CTS.
Study design
Four groups;
a CTS-patient group and
three control groups (tendovaginitis stenosans (TVS), M Dupuytren and traumas
to the hand)
are being compared, with regard to:
1. joint stiffness,
2. skin stiffness,
3. physical activities, measured by a standardised questionnaire,
4. body water, measured by multi frequency bio-impedance measurement
Intervention
The CTS group; a normal carpal tunnel release will be performed, with an
additional biopsy of the flexor retinaculum. A biopsy of excess skin is taken
as well.
The patients with TVS receive regular care by the section of the pulley. A
biopsy is taken from excess skin.
In patients with M. Dupuytren a regular fasciotomy will be performed and a
biopsy of the skin is taken.
Patients with a trauma to the hand wil receive normal care. A biopsy of the
skin is taken
Study burden and risks
CTS group, regular out-patient clinic visit on account of CTS complaints.
One-off extra visit, taking 20-30 minutes in which a stiffness measurement is
done, a questionnaire is taken and a body water measurement is done. The next
visit the carpal tunnel release is performed as described above
(interventions).
The control groups (TVS, M. Dupuytren and trauma's to the hand) will have there
regular out-patient clinic visits. One extra visit, of approximately 20-30
minutes in which a stiffness measurement is done, a questionnaire is taken and
a body water measurement is done. Next visit contains the operation. In the
group of patients with a trauma to the hand these additional test will be
performed after the treatment.
Koekoekslaan 1
3435CM Nieuwegein
NL
Koekoekslaan 1
3435CM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
Clinical CTS supported by positive EMG and a positive Boston Questionnaire
Exclusion criteria
hypo/hyperthyroidea, diabetes, rheumatoid arthritis, pregnancy, body mass index (BMI)>30, anatomical deviations in hand or wrist, muscle/skeleton affections.
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 |
---|---|
ClinicalTrials.gov | NCT01081860 |
CCMO | NL30011.100.10 |