Treatment for Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
decompression
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome focused on measuring Cubital tunnel, treatment, nerve compression
Eligibility Criteria
Inclusion Criteria: Patients with cubital tunnel syndrome Exclusion Criteria: Rheumatoid arthritis (RA) Osteoarthrosis Varus or valgus deformities at elbow
Sites / Locations
- St Olavs Hospital
Outcomes
Primary Outcome Measures
pain
Secondary Outcome Measures
electroneurography (ENG
electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
paresthesia
weakness
patient satisfaction
Full Information
NCT ID
NCT00184158
First Posted
September 12, 2005
Last Updated
August 17, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00184158
Brief Title
Treatment for Cubital Tunnel Syndrome
Official Title
Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (Actual)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.
The study is performed at 5 different hospitals in Norway.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
Keywords
Cubital tunnel, treatment, nerve compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
decompression
Intervention Description
Conservative, simple decompression and nerve transfer
Primary Outcome Measure Information:
Title
pain
Secondary Outcome Measure Information:
Title
electroneurography (ENG
Description
electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
Title
paresthesia
Title
weakness
Title
patient satisfaction
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with cubital tunnel syndrome
Exclusion Criteria:
Rheumatoid arthritis (RA)
Osteoarthrosis
Varus or valgus deformities at elbow
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilhjalmur Finsen, Prof
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Treatment for Cubital Tunnel Syndrome
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