NCT05538598

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

September 7, 2022

Last Update Submit

December 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Pressure-pain threshold

    The measured pressure at the moment the perception of pressure turns into pain

    Within 10 minutes of intervention

Study Arms (1)

Intramuscular Dry Needling

EXPERIMENTAL

IMDN will be performed at the sacral multifidus and fibularis longus muscles.

Procedure: Intramuscular Dry Needling

Interventions

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.

Intramuscular Dry Needling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over the age of 18
  • pain-free in your lower back and lower legs

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael Koehle, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Repeated measures design with pre-post measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 14, 2022

Study Start

December 31, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share