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Treatment for Cubital Tunnel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184158
First received: September 12, 2005
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  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 2

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:

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:
    Procedure: decompression
    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:
Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013