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Carpal Tunnel Release in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT01201109
Recruitment Status : Unknown
Verified September 2010 by Skane University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : September 14, 2010
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Skane University Hospital

September 13, 2010
September 14, 2010
September 28, 2010
November 2010
December 2011   (Final data collection date for primary outcome measure)
Patient self-reported outcome questionnaire [ Time Frame: 5 years after carpal tunnel release ]
Measured by 1). Boston Carpal Tunnel Questionnaire regarding carpal tunnel symptoms and disability. 2). Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) registering health-related quality of life. 3). Cold intolerance on a CISS score
Patient self-reported outcome questionnaire [ Time Frame: 5 years after carpal tunnel release ]
Complete list of historical versions of study NCT01201109 on ClinicalTrials.gov Archive Site
Nerve conduction study and vibrotactile sense [ Time Frame: 5 years after carpal tunnels release ]
Change in Median nerve function by measuring Distal motor latency and antidromic sensory conduction velocity over the carpal tunnel segment. Evaluate development of peripheral neuropathy by measure of sural nerve sensory conduction velocity, sural nerve amplitude and peroneal nerve motor conduction velocity. Vibrotactile sense of the hand measured at 7 difference frequences from 5 - 500 Hz.
Nerve conduction study [ Time Frame: 5 years after carpal tunnels release ]
Not Provided
Not Provided
 
Carpal Tunnel Release in Diabetic Patients
Five Years Follow-up After Carpal Tunnel Release in Diabetic and Non-diabetic Patients
The aim of this study is to extend a previously reported 1 year follow-up on carpal tunnel release, in matched diabetic and non-diabetic patients,to compare outcomes 5 years after surgery.

The Follow-up investigation includes:

  1. Clinical examination of sensory and motor function
  2. Generic and disease specific self-administered questionnaires
  3. Nerve conduction study
  4. Vibration threshold testing
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Prospective series of matched diabetic and non-diabetic patients who were operated for carapl tunnel syndrome 5 years ago.
  • Carpal Tunnel Syndrome
  • Diabetes
  • Nerve Entrapment
Not Provided
  • Diabetics
    Diabetic patients operated for carpal tunnel syndrome
  • Non-diabetics
    Non-diabetic patients operated for carpal tunnel syndrome
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
66
Same as current
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diabetic and non-diabetic patients operated for carpal tunnel syndrome 5 years ago.

Exclusion Criteria:

  • previous carpal tunnel release in the hand under study
  • clinical signs of nerve entrapment other than CTS
  • cervical radiculopathy, inflammatory joint disease
  • renal failure
  • thyroid disorders
  • previous wrist fracture on the affected side
  • daily long-term exposure to vibrating tools
  • pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01201109
2010/354
No
Not Provided
Not Provided
Niels Thomsen, MD, PhD, Dept of Hand Surgery, Skåne University Hospital, Malmö
Skane University Hospital
Not Provided
Study Chair: Lars Dahlin, Md, PhD
Skane University Hospital
September 2010