Treatment for Cubital Tunnel Syndrome - Full Text View

Sponsor:	Norwegian University of Science and Technology
Information provided by (Responsible Party):	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: decompression	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

pain [ Designated as safety issue: No ]

Secondary Outcome Measures:

electroneurography (ENG [ Designated as safety issue: No ]
electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
paresthesia [ Designated as safety issue: No ]
weakness [ Designated as safety issue: No ]
patient satisfaction [ Designated as safety issue: No ]

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

Intervention Details:

Conservative, simple decompression and nerve transfer

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with cubital tunnel syndrome

Exclusion Criteria:

Rheumatoid arthritis (RA)
Osteoarthrosis
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
ClinicalTrials.gov Identifier:	NCT00184158 History of Changes
Other Study ID Numbers:	056-02
Study First Received:	September 12, 2005
Last Updated:	August 25, 2011
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:

Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on February 13, 2012