Treatment for Cubital Tunnel Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

March 3, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Reduction of symptoms:
Pain
weakness
And patients satisfaction whith the treatment
Paraesthesis

Change History

Complete list of historical versions of study NCT00184158 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Evaluation of the ENG before and after the operation and to see if it is consistent whith patient the evaluation.

Descriptive Information

Brief Title ^ICMJE

Treatment for Cubital Tunnel Syndrome

Official Title ^ICMJE

Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cubital Tunnel Syndrome

Intervention ^ICMJE

Procedure: Conservative, simple decompression and nerve transfer

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with cubital tunnel

Exclusion Criteria:

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00184158

Responsible Party

Professor MD PhD Vilhjalmur Finsen, Norwegian University of Science and Technology

Study ID Numbers ^ICMJE

056-02

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Vilhjalmur Finsen, Profesor

NTNU

Information Provided By

Norwegian University of Science and Technology

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP