NCT01081860

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

6 months

First QC Date

March 2, 2010

Last Update Submit

April 26, 2010

Conditions

Keywords

Carpal tunnel syndromeCTSSkinstiffnessJointstiffness

Outcome Measures

Primary Outcomes (2)

  • Joint stiffness

    The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.

    In the 1st month

  • Stiffness of the skin

    Skinstiffness is measured with a suction cup

    in the 1st month

Secondary Outcomes (1)

  • Physical activities

    In the 1st month

Study Arms (4)

Carpal tunnel syndrome

Patients with carpal tunnel syndrome

Trigger finger

Patients with trigger fingers

Dupuytren Contracture

Patients with Dupuytren

Trauma to the hand

Patients with an acute trauma to the hand

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting with complaints of: * Carpal tunnel syndrome * Trigger finger * Dupuytren contracture * an acute trauma to the hand

You may qualify if:

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

You may not qualify if:

  • Hypo-/hyperthyroidism
  • Diabetes
  • Arthritis
  • Pregnancy
  • Obesity (BMI \>30)
  • Anatomical anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 3430EM, Netherlands

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • A.B. Mink van der Molen, dr.

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 5, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations