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IMS-treatment and Canalis Carpi Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Needle in acupuncture point Li11
IMS of the musculus pronator teres
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uni Health, Uni Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Needle in acupuncture point Li11

IMS of musculus pronator teres

Arm Description

Acupuncture needle in the acupuncture point Li11

Acupuncture needle in musculus pronator teres

Outcomes

Primary Outcome Measures

Diameter of the Nervae medianus in the Carpal Tunnel

Secondary Outcome Measures

Health complaints
Power of the hand grip

Full Information

First Posted
March 29, 2010
Last Updated
January 20, 2012
Sponsor
NORCE Norwegian Research Centre AS
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1. Study Identification

Unique Protocol Identification Number
NCT01102868
Brief Title
IMS-treatment and Canalis Carpi Syndrome
Official Title
An Randomized Controlled Trial of IMS-treatment Versus Scam for Canalis Carpi Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needle in acupuncture point Li11
Arm Type
Sham Comparator
Arm Description
Acupuncture needle in the acupuncture point Li11
Arm Title
IMS of musculus pronator teres
Arm Type
Experimental
Arm Description
Acupuncture needle in musculus pronator teres
Intervention Type
Device
Intervention Name(s)
Needle in acupuncture point Li11
Other Intervention Name(s)
Needles
Intervention Description
Acupuncture needle in acupuncture point Li11
Intervention Type
Device
Intervention Name(s)
IMS of the musculus pronator teres
Other Intervention Name(s)
Needles
Intervention Description
Acupuncture needle in musculus pronator teres
Primary Outcome Measure Information:
Title
Diameter of the Nervae medianus in the Carpal Tunnel
Time Frame
End 2011
Secondary Outcome Measure Information:
Title
Health complaints
Time Frame
End 2011
Title
Power of the hand grip
Time Frame
End 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stein Atle Lie, Professor
Organizational Affiliation
Uni Health, University Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uni Health, Uni Research
City
Bergen
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34391281
Citation
Kvist KB, Hilland R, Enehaug R, Schjelderup J, Lie SA, Halse AK. The treatment effect of intramuscular stimulation on carpal tunnel syndrome: A blinded randomized trial on 75 patients. J Bodyw Mov Ther. 2021 Jul;27:522-528. doi: 10.1016/j.jbmt.2021.03.020. Epub 2021 Apr 20.
Results Reference
derived

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IMS-treatment and Canalis Carpi Syndrome

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