Dry Needling and Muscle Stiffness

December 12, 2022 updated by: Michael Koehle, University of British Columbia

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

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Koehle, MD, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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