- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00184158
Treatment for Cubital Tunnel Syndrome
August 17, 2017 updated by: Norwegian University of Science and Technology
Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7006
- St Olavs Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with cubital tunnel syndrome
Exclusion Criteria:
- Rheumatoid arthritis (RA)
- Osteoarthrosis
- Varus or valgus deformities at elbow
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
pain
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
patient satisfaction
|
|
weakness
|
|
electroneurography (ENG
|
electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
|
paresthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Vilhjalmur Finsen, Prof, National Taiwan Normal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2005
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 17, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Wounds and Injuries
- Disease
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Ulnar Nerve Compression Syndromes
- Ulnar Neuropathies
- Syndrome
- Cubital Tunnel Syndrome
Other Study ID Numbers
- 056-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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