IMS-treatment and Canalis Carpi Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102868
• Other study ID #: IMS1234
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: January 20, 2012
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Needle in acupuncture point Li11
Acupuncture needle in acupuncture point Li11
• IMS of the musculus pronator teres
Acupuncture needle in musculus pronator teres

Locations

Country	Name	City	State
Norway	Uni Health, Uni Research	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Uni Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of the Nervae medianus in the Carpal Tunnel		End 2011	No
Secondary	Health complaints		End 2011	No
Secondary	Power of the hand grip		End 2011	No