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IMS-treatment and Canalis Carpi Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT01102868
First received: March 29, 2010
Last updated: January 20, 2012
Last verified: January 2012
History of Changes

March 29, 2010
January 20, 2012
April 2009
January 2012   (final data collection date for primary outcome measure)
Diameter of the Nervae medianus in the Carpal Tunnel [ Time Frame: End 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01102868 on ClinicalTrials.gov Archive Site
  • Health complaints [ Time Frame: End 2011 ] [ Designated as safety issue: No ]
  • Power of the hand grip [ Time Frame: End 2011 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IMS-treatment and Canalis Carpi Syndrome
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.

The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • Device: Needle in acupuncture point Li11
    Acupuncture needle in acupuncture point Li11
    Other Name: Needles
  • Device: IMS of the musculus pronator teres
    Acupuncture needle in musculus pronator teres
    Other Name: Needles
  • Sham Comparator: Needle in acupuncture point Li11
    Acupuncture needle in the acupuncture point Li11
    Intervention: Device: Needle in acupuncture point Li11
  • Experimental: IMS of musculus pronator teres
    Acupuncture needle in musculus pronator teres
    Intervention: Device: IMS of the musculus pronator teres
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 67 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01102868
IMS1234
No
Uni Research
Uni Research
Not Provided
Principal Investigator: Stein Atle Lie, Professor Uni Health, University Research
Uni Research
January 2012

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