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NCT00775333 Clinical Trial

Nerve Entrapment in Diabetic Patients

Carpal Tunnel Syndrome Clinical Trial

Official title:
Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00775333
Other study ID # LU 508-03
Secondary ID
Status Completed
Phase N/A
First received October 17, 2008
Last updated October 17, 2008
Start date December 2003
Est. completion date April 2008

Study information
Verified date October 2008
Source Skane University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome

- Confirmed by nerve conduction studies.

Exclusion Criteria:

- Other focal nerve entrapments

- Cervical radiculopathy

- Inflammatory joint disease

- Renal failure

- Thyroid disorders

- Previous wrist fracture

- Long-term exposure to vibrating tools.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Outcome after carpal tunnel release
Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients

Locations
Country Name City State
Sweden Dept. of Hand Surgery, Malmo University Hospital Malmo

Sponsors (1)
Lead Sponsor Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength) Baseline, 6 weeks, 12 weeks, 52 weeks No
Secondary Pillar pain, cold intolerance, and patient satisfaction. Baseline, 6 weeks, 12 weeks, 52 weeks No
See also
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Recruiting NCT01897272 - Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study N/A
Completed NCT01394822 - Neuromuscular Ultrasound for Focal Neuropathies N/A
Enrolling by invitation NCT01017471 - Carpal Tunnel Syndrome Release Using PSU Retractor Phase 3