- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538598
Dry Needling and Muscle Stiffness
Effect of Intramuscular Dry Needling on Soft Tissue Stiffness and Pressure-pain Thresholds
The goal of this study is to investigate the effect of intramuscular dry needling (IMDN) on muscle stiffness and pain. Research has suggested that IMDN can reduce muscle stiffness in needled areas. As well, IMDN may reduce mechanical pain sensitivity experienced by individuals.
IMDN will be performed at several anatomical locations. Muscle stiffness will be measured with a handheld probe, which measures contact force and displacement of soft tissue. Pressure-pain thresholds (PPT) will be discovered at each region of interest. Stiffness and pressure-pain thresholds will be collected before and after IMDN. The data collected from this research is important to understand the mechanism of IMDN and its relationship to pain.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Koehle, MD, PhD
- Phone Number: 604 822 9331
- Email: michael.koehle@ubc.ca
Study Contact Backup
- Name: Pearson Wyder-Hodge, BSc
- Phone Number: 778 887 7735
- Email: wyderhod@student.ubc.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- over the age of 18
- pain-free in your lower back and lower legs
Exclusion Criteria:
- unable to communicate in English
- surgery of any kind in the lumbar spine or lower legs.
- participants with a skin condition that does not allow for hypoallergenic tape to be attached to their skin.
- have a BMI>25
- unable to hold your breath for 20 seconds
- contraindications to dry needling, i.e. pregnancy; fever or infection that is in your bloodstream; unstable compromised immune system; unstable bleeding disorders; presence at the site of DN of infection, an open wound , a burn, cellulitis, or an undiagnosed lump; post- mastectomy/lymph node removal in the affected limb; post-major surgery (3-6 month time period); presence of metal or plastic implant; absent sensation in area of planned DN; post-bacterial endocarditis or heart valve conditions/replacement without medical clearance for DN from medical doctor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intramuscular Dry Needling
IMDN will be performed at the sacral multifidus and fibularis longus muscles.
|
The insertion of thin monofilament needles (without injectate) into a tight band of muscle.
The needles will be inserted into the muscle for ~10 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective stiffness of soft tissue
Time Frame: Within 10 minutes of intervention
|
Force-displacement data is collected while deforming the soft tissue at the skin surface with a non-invasive handheld probe.
The effective stiffness is a summary of the deformation behavior of the soft tissue.
It is estimated using the force-displacement data as an input to the incompressible isotropic hyperelastic Ogden model.
A higher value indicates that the soft tissue is stiffer than a lower value.
|
Within 10 minutes of intervention
|
Pressure-pain threshold
Time Frame: Within 10 minutes of intervention
|
The measured pressure at the moment the perception of pressure turns into pain
|
Within 10 minutes of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Koehle, MD, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H22-01852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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