IMS-treatment and Canalis Carpi Syndrome

NCT ID: NCT01102868

Last Updated: 2012-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Needle in acupuncture point Li11

Acupuncture needle in the acupuncture point Li11

Group Type SHAM_COMPARATOR

Needle in acupuncture point Li11

Intervention Type DEVICE

Acupuncture needle in acupuncture point Li11

IMS of musculus pronator teres

Acupuncture needle in musculus pronator teres

Group Type EXPERIMENTAL

IMS of the musculus pronator teres

Intervention Type DEVICE

Acupuncture needle in musculus pronator teres

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Needle in acupuncture point Li11

Acupuncture needle in acupuncture point Li11

Intervention Type DEVICE

IMS of the musculus pronator teres

Acupuncture needle in musculus pronator teres

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Needles Needles

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NORCE Norwegian Research Centre AS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stein Atle Lie, Professor

Role: PRINCIPAL_INVESTIGATOR

Uni Health, University Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uni Health, Uni Research

Bergen, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34391281 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IMS1234

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mild Carpal Tunnel Syndrome
NCT00981565 COMPLETED NA
Acupuncture for Carpal Tunnel Syndrome
NCT00000394 COMPLETED PHASE2