Muscle TightnessNCT05538598
Dry Needling and Muscle Stiffness
A study testing Intramuscular Dry Needling in people with Muscle Tightness, run by University of British Columbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Intramuscular Dry Needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18
- pain-free in your lower back and lower legs
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Muscle Tightness
- Being tested
- Intramuscular Dry Needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular Dry NeedlingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Dry Needling | Experimental | IMDN will be performed at the sacral multifidus and fibularis longus muscles. Receives: Procedure: Intramuscular Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 minutes of intervention
Pressure-pain threshold
The measured pressure at the moment the perception of pressure turns into pain
Measured: Within 10 minutes of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start31 Dec 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Change in research personnel.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TightnessStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design with pre-post measures
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koehle, University of British Columbia
- Investigators
- Michael Koehle, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538598
- Sponsor's protocol ID
- H22-01852
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intramuscular Dry Needling on Soft Tissue Stiffness and Pressure-pain Thresholds
- ClinicalTrials.gov ID
- NCT05538598
- Acronym / sponsor ID
- H22-01852
- Conditions
- Muscle Tightness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research personnel.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design with pre-post measures
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Dry Needling | Experimental | Procedure: Intramuscular Dry NeedlingIMDN will be performed at the sacral multifidus and fibularis longus muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over the age of 18
- pain-free in your lower back and lower legs
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular Dry NeedlingThe insertion of thin monofilament needles (without injectate) into a tight band of muscle. The needles will be inserted into the muscle for ~10 seconds. | Procedure or surgery | Intramuscular Dry Needling |
Primary outcome
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.
Pressure-pain threshold
Time frame: Within 10 minutes of intervention
The measured pressure at the moment the perception of pressure turns into pain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Koehle, MD, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular Dry Needling in people with Muscle Tightness, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective stiffness of soft tissue (time frame: Within 10 minutes of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.