IMS-treatment and Canalis Carpi Syndrome

January 20, 2012 updated by: NORCE Norwegian Research Centre AS

An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Uni Health, Uni Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diameter of the Nervae medianus in the Carpal Tunnel
Time Frame: End 2011
End 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Health complaints
Time Frame: End 2011
End 2011
Power of the hand grip
Time Frame: End 2011
End 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMS1234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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