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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):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
pain
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Reduction of symptoms:
  • Pain
  • Paraesthesis
  • weakness
  • And patients satisfaction whith the treatment
Change History Complete list of historical versions of study NCT00184158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
  • electroneurography (ENG
    electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation.
  • paresthesia
  • weakness
  • patient satisfaction
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Evaluation of the ENG before and after the operation and to see if it is consistent whith patient the evaluation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cubital Tunnel Syndrome
Intervention  ICMJE Procedure: decompression
Conservative, simple decompression and nerve transfer
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2009)
81
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
30
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with cubital tunnel syndrome

Exclusion Criteria:

  • Rheumatoid arthritis (RA)
  • Osteoarthrosis
  • Varus or valgus deformities at elbow
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00184158
Other Study ID Numbers  ICMJE 056-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Vilhjalmur Finsen, Prof NTNU
PRS Account Norwegian University of Science and Technology
Verification Date August 2017

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