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Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome (STIF-CTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01081860
Recruitment Status : Unknown
Verified April 2010 by St. Antonius Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2010
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
St. Antonius Hospital

Tracking Information
First Submitted Date March 2, 2010
First Posted Date March 5, 2010
Last Update Posted Date April 27, 2010
Study Start Date May 2010
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2010)
  • Joint stiffness [ Time Frame: In the 1st month ]
    The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.
  • Stiffness of the skin [ Time Frame: in the 1st month ]
    Skinstiffness is measured with a suction cup
Original Primary Outcome Measures
 (submitted: March 4, 2010)
  • Joint stiffness [ Time Frame: In the 1st month ]
    The active range of motion (elbow, wrist, knee and ankle) is measured with a standard goniometer.
  • Connective tissue composition [ Time Frame: Biopsies are taken during treatment and analysed at the end of the study ]
    Biopsies are analysed for collagen composition.
Change History
Current Secondary Outcome Measures
 (submitted: March 4, 2010)
Physical activities [ Time Frame: In the 1st month ]
Boston Questionairre
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stiffness of the Skin and Joints in Relation to Carpal Tunnel Syndrome
Official Title Correlation of Joint Stiffness and Stiffness of the Skin and the Prevelation of Carpal Tunnel Syndrome (CTS)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients presenting with complaints of:

  • Carpal tunnel syndrome
  • Trigger finger
  • Dupuytren contracture
  • an acute trauma to the hand
Condition Carpal Tunnel Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 4, 2010)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2010
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01081860
Other Study ID Numbers STIF CTS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party dr. A.B. Mink van der Molen, department of plastic surgery St Antonius Hospital
Study Sponsor St. Antonius Hospital
Collaborators Not Provided
Investigators
Principal Investigator: A.B. Mink van der Molen, dr. St. Antonius Hospital
PRS Account St. Antonius Hospital
Verification Date April 2010