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NCT01081860 Clinical Trial

Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

— STIF-CTS  

Official title:
Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01081860
Other study ID # STIF CTS
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 2, 2010
Last updated April 26, 2010
Start date May 2010
Est. completion date December 2010

Study information
Verified date April 2010
Source St. Antonius Hospital
Contact Bo Verwer
Email b.verwer@antoniusziekenhuis.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The exact etiology 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.

The investigators 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.

A relation between connective tissue composition and joint stiffness is proven. This relationship possibly extends to a relation between stiffness of the skin, joint stiffness and the prevalence of CTS.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Caucasian

- Carpal tunnel release OR Trigger finger OR Dupuytren OR an acute trauma to the hand

Exclusion Criteria:

- Hypo-/hyperthyroidism

- Diabetes

- Arthritis

- Pregnancy

- Obesity (BMI >30)

- Anatomical anomalies

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands St Antonius Hospital Nieuwegein Utrecht

Sponsors (1)
Lead Sponsor Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Joint stiffness The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer. In the 1st month No
Primary Stiffness of the skin Skinstiffness is measured with a suction cup in the 1st month No
Secondary Physical activities Boston Questionairre In the 1st month No
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