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Treatment for Cubital Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00184158
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Cubital Tunnel Syndrome Procedure: decompression

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives
Actual Study Start Date : January 2005
Primary Completion Date : January 2009
Study Completion Date : January 2009


Arms and Interventions

Intervention Details:
    Procedure: decompression
    Conservative, simple decompression and nerve transfer

Outcome Measures

Primary Outcome Measures :
  1. pain

Secondary Outcome Measures :
  1. electroneurography (ENG
    electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.

  2. paresthesia
  3. weakness
  4. patient satisfaction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184158


Locations
Norway
St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Vilhjalmur Finsen, Prof NTNU
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184158     History of Changes
Other Study ID Numbers: 056-02
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Cubital tunnel
treatment
nerve compression

Additional relevant MeSH terms:
Cubital Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
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