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NCT Number: NCT01102868

IMS-treatment and 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.

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Key information

Conditions

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

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uni Health, Uni Research

Bergen, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Needle in acupuncture point Li11

Device

Acupuncture needle in acupuncture point Li11

Other names: Needles

IMS of the musculus pronator teres

Device

Acupuncture needle in musculus pronator teres

Other names: Needles

Primary outcomes

  1. Diameter of the Nervae medianus in the Carpal Tunnel

    Time frame: End 2011

Secondary outcomes

  1. Health complaints

    Time frame: End 2011

  2. Power of the hand grip

    Time frame: End 2011

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2010
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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