Treatment for Cubital Tunnel Syndrome

This study has been completed.

First Received: September 12, 2005 Last Updated: March 3, 2009 History of Changes

Sponsor:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00184158

Purpose

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.

Condition	Intervention	Phase
Cubital Tunnel Syndrome	Procedure: Conservative, simple decompression and nerve transfer	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Reduction of symptoms: pain
paresthesia
weakness
and patient satisfaction with the treatment

Secondary Outcome Measures:

Evaluation of the electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.

Enrollment:	81
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cubital tunnel

Exclusion Criteria:

Rheumatoid arthritis (RA) patients
Osteoarthrosis patients
Varus or valgus deformities at elbow

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184158

Locations

Norway
St Olavs Hospital
TRONDHEIM, Norway, 7006

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Study Director:

Vilhjalmur Finsen, Profesor

NTNU

More Information

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Professor MD PhD Vilhjalmur Finsen )
Study ID Numbers:	056-02
Study First Received:	September 12, 2005
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00184158 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Cubital tunnel
treatment
nerve compression

Additional relevant MeSH terms:

Disease
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Cubital Tunnel Syndrome
Mononeuropathies
Nerve Compression Syndromes
Ulnar Neuropathies

Pathologic Processes
Neuromuscular Diseases
Syndrome
Peripheral Nervous System Diseases
Ulnar Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains

ClinicalTrials.gov processed this record on November 27, 2009