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IMS-treatment and Canalis Carpi Syndrome

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

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
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

Resource links provided by NLM:

Further study details as provided by Uni Research:

Primary Outcome Measures:
  • Diameter of the Nervae medianus in the Carpal Tunnel [ Time Frame: End 2011 ]

Secondary Outcome Measures:
  • Health complaints [ Time Frame: End 2011 ]
  • Power of the hand grip [ Time Frame: End 2011 ]

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

Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01102868

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

Responsible Party: Uni Research Identifier: NCT01102868     History of Changes
Other Study ID Numbers: IMS1234
Study First Received: March 29, 2010
Last Updated: January 20, 2012

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries processed this record on September 21, 2017