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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
  Purpose

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 Intervention
Carpal Tunnel Syndrome
 Device: Needle in acupuncture point Li11
Device: IMS of the musculus pronator teres

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Diameter of the Nervae medianus in the Carpal Tunnel [ Time Frame: End 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: April 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Needles

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102868

Locations
Norway
Uni Health, Uni Research
Bergen, Norway
Sponsors and Collaborators
Uni Research
Investigators
Principal Investigator: Stein Atle Lie, Professor Uni Health, University Research
  More Information

No publications provided

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT01102868     History of Changes
Other Study ID Numbers: IMS1234
Study First Received: March 29, 2010
Last Updated: January 20, 2012
Health Authority: Norway: Ethics Committee
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013