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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05538598
Other study ID # H22-01852
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2022
Est. completion date September 2023

Study information

Verified date December 2022
Source University of British Columbia
Contact Michael Koehle, MD, PhD
Phone 604 822 9331
Email michael.koehle@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intramuscular Dry Needling
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Outcome

Type Measure Description Time frame Safety issue
Primary Effective stiffness of soft tissue 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
Primary Pressure-pain threshold The measured pressure at the moment the perception of pressure turns into pain Within 10 minutes of intervention
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