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Treatment for Cubital Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT00184158
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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 Phase
Cubital Tunnel Syndrome Procedure: decompression Not Applicable

Study Design
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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
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Procedure: decompression
    Conservative, simple decompression and nerve transfer

Outcome Measures
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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
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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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
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Norway
St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
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Study Director: Vilhjalmur Finsen, Prof NTNU
More Information
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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

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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:
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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