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IMS-treatment and Canalis Carpi Syndrome

Sponsor
NORCE Norwegian Research Centre AS (Other)
Overall Status
Completed
CT.gov ID
NCT01102868
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
33
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery.

In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to release the tension of nervus medianus in the lower arm. The study will be performed by randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower arm.

Condition or Disease Intervention/Treatment Phase
  • Device: Needle in acupuncture point Li11
  • Device: IMS of the musculus pronator teres
 N/A

Detailed Description

The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Needle in acupuncture point Li11

Acupuncture needle in the acupuncture point Li11

Device: Needle in acupuncture point Li11
Acupuncture needle in acupuncture point Li11
Other Names:
  • Needles

    		•
    Experimental: IMS of musculus pronator teres

    Acupuncture needle in musculus pronator teres

    Device: IMS of the musculus pronator teres
    Acupuncture needle in musculus pronator teres
    Other Names:
  • Needles

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diameter of the Nervae medianus in the Carpal Tunnel [End 2011]

    Secondary Outcome Measures

    1. Health complaints [End 2011]

    2. Power of the hand grip [End 2011]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 67 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Canalis Carpi Syndrome verified by ultrasound and clinically

    • Both genders

    • Age from 18 to 67

    Exclusion Criteria:

    • Negative neurophysiology result.

    • Epilepsy,

    • Heart disease,

    • Rheumatism

    • Unstable angina pectoris,

    • Metal -allergy,

    • Needle- phobia,

    • Infection

    • Hemophilia

    • Cognitive problems

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uni Health, Uni Research Bergen Norway

    Sponsors and Collaborators

    • NORCE Norwegian Research Centre AS

    Investigators

    • Principal Investigator: Stein Atle Lie, Professor, Uni Health, University Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NORCE Norwegian Research Centre AS
    ClinicalTrials.gov Identifier:
    NCT01102868
    Other Study ID Numbers:
    • IMS1234
    First Posted:
    Apr 13, 2010
    Last Update Posted:
    Jan 23, 2012
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jan 23, 2012