Trigger PointsNCT04161105
Treatment Time-frame Guideline for Dry Needling in the Lower Limb
A study testing Dry needling in people with Trigger Points, run by South East Technological University at 1 site in Ireland.
Trial summary
This study evaluates the impact of treating myofascial trigger points with a single session of dry needling on maximal isometric strength in the short term. Two groups will receive dry needling in separate muscle groups and a third group will receive no dry needling. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Trigger Points
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIreland
- Study dates
- 16 Sep 2019to 29 Nov 2019
- 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have latent trigger points in their rectus femoris and gluteus maximus
Who cannot join
- Active trigger points in rectus femoris or gluteus maximus
- Participants with current injuries
- History of fibromyalgia or myofascial pain syndrome
- History of blood disorder which prevents dry needling
- Needle phobia
- History of surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Time-frame Guidelines for Myofascial Dry Needling of Latent Myofascial Trigger Points in the Muscles of the Lower Limb Kinetic Chain.
This study evaluates the impact of treating myofascial trigger points with a single session of dry needling on maximal isometric strength in the short term. Two groups will receive dry needling in separate muscle groups and a third group will receive no dry needling.
Read the detailed description
Dry needling is a effective treatment for myofascial trigger points. It is very common in a sporting environment. Strength is a key aspect of athletic performance. Despite the prevalence of dry needling within a sporting environment, the effects of dry needling on strength remains unknown.
This study will investigate the effects of dry needling on maximal isometric strength with a view to informing clinical practice amongst clinicians working in the elite sport setting.
- Conditions
- Trigger Points
- Being tested
- Dry needling
- Keywords
- Dry needling, Strength, Latent trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Also called Myofascial dry needling
Dry needling is an invasive procedure involving inserting acupuncture needles directly into trigger points within muscles. The needle is partially withdrawn and re-inserted repeatedly to maximally stimulate the muscle and it's fibers.
| Study group | Role | What they receive |
|---|---|---|
| Rectus femoris dry needling group | Experimental | The rectus femoris dry needling group will have their strength assessed. They will then receive one treatment of dry needling to a trigger point in their rectus femoris muscle. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling. Receives: Procedure: Dry needling |
| Gluteus maximus dry needling group | Experimental | The gluteus maximus dry needling group will have their strength assessed. They will then receive one treatment of dry needling to trigger points in their gluteus maximus muscle only. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling. Receives: Procedure: Dry needling |
| Control | No intervention | This group will receive no intervention. They will have their strength assessed at baseline and 24, 48 \& 72 hour follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric peak force during the isometric mid-thigh pull
Measured in newtons. It is the amount of force exerted by pulling against an immovable bar. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Isometric peak rate of force development during the isometric mid-thigh pull
Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Relative isometric peak force during the isometric mid-thigh pull
Measured in newtons per kg body weight. It is the amount of force exerted by pulling against an immovable bar divided by two thirds the participants body weight. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Relative isometric peak rate of force development during the isometric mid-thigh pull
Measured in newtons per second squared per kg. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by two thirds the participants body weight. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Normalised isometric peak rate of force development during the isometric mid-thigh pull
Measured in newtons per second squared and expressed relative to each participant peak force. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by the peak vertical ground reaction force produced during the trial. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Isometric time interval rate of force development during the isometric mid-thigh pull
Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. With values expressed in specific time interval windows (0ms to 50ms, 0-100ms, 0-150ms, 0-200ms, 0-250ms) It is measured as vertical ground reaction by force platforms beneath the participants feet.
Measured: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start16 Sep 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger PointsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with latent trigger points in rectus femoris (RF) and gluteus maximus (GM) muscles will be stratified evenly into 3 groups (RF dry needling, GM dry needling or control) based on baseline strength. Treatment, data collection and data analysis of all participants will be conducted concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darragh O'Meara, South East Technological University
- Investigators
- Darragh O' Meara, BSc, Principal investigator, South East Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161105
- Sponsor's protocol ID
- DomMSc
- Status last verified
- Feb 2020
- First submitted
- 11 Nov 2019
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Time-frame Guidelines for Myofascial Dry Needling of Latent Myofascial Trigger Points in the Muscles of the Lower Limb Kinetic Chain.
- ClinicalTrials.gov ID
- NCT04161105
- Acronym / sponsor ID
- DomMSc
- Conditions
- Trigger Points
- Keywords
- Dry needling, Strength, Latent trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- South East Technological UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 13 Nov 2019 (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.
This study evaluates the impact of treating myofascial trigger points with a single session of dry needling on maximal isometric strength in the short term. Two groups will receive dry needling in separate muscle groups and a third group will receive no dry needling.
Detailed description
Dry needling is a effective treatment for myofascial trigger points. It is very common in a sporting environment. Strength is a key aspect of athletic performance. Despite the prevalence of dry needling within a sporting environment, the effects of dry needling on strength remains unknown.
This study will investigate the effects of dry needling on maximal isometric strength with a view to informing clinical practice amongst clinicians working in the elite sport setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants with latent trigger points in rectus femoris (RF) and gluteus maximus (GM) muscles will be stratified evenly into 3 groups (RF dry needling, GM dry needling or control) based on baseline strength. Treatment, data collection and data analysis of all participants will be conducted concurrently.
| Arm | Type | Receives |
|---|---|---|
| Rectus femoris dry needling group | Experimental | Procedure: Dry needlingThe rectus femoris dry needling group will have their strength assessed. They will then receive one treatment of dry needling to a trigger point in their rectus femoris muscle. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling. |
| Gluteus maximus dry needling group | Experimental | Procedure: Dry needlingThe gluteus maximus dry needling group will have their strength assessed. They will then receive one treatment of dry needling to trigger points in their gluteus maximus muscle only. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling. |
| Control | No intervention | –This group will receive no intervention. They will have their strength assessed at baseline and 24, 48 \& 72 hour follow-up |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must have latent trigger points in their rectus femoris and gluteus maximus
Key exclusion criteria (6 listed)
- Active trigger points in rectus femoris or gluteus maximus
- Participants with current injuries
- History of fibromyalgia or myofascial pain syndrome
- History of blood disorder which prevents dry needling
- Needle phobia
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 |
|---|---|---|
| Dry needlingAlso: Myofascial dry needlingDry needling is an invasive procedure involving inserting acupuncture needles directly into trigger points within muscles. The needle is partially withdrawn and re-inserted repeatedly to maximally stimulate the muscle and it's fibers. | Procedure or surgery | Gluteus maximus dry needling group, Rectus femoris dry needling group |
Primary outcome
Isometric peak force during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons. It is the amount of force exerted by pulling against an immovable bar. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.
Isometric peak rate of force development during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Relative isometric peak force during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons per kg body weight. It is the amount of force exerted by pulling against an immovable bar divided by two thirds the participants body weight. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.
Relative isometric peak rate of force development during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons per second squared per kg. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by two thirds the participants body weight. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Normalised isometric peak rate of force development during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons per second squared and expressed relative to each participant peak force. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by the peak vertical ground reaction force produced during the trial. It is measured as vertical ground reaction by force platforms beneath the participants feet.
Isometric time interval rate of force development during the isometric mid-thigh pull
Time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.
Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. With values expressed in specific time interval windows (0ms to 50ms, 0-100ms, 0-150ms, 0-200ms, 0-250ms) It is measured as vertical ground reaction by force platforms beneath the participants feet.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- 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.
Darragh O' Meara, BSc principal investigator
South East Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Trigger Points, run by South East Technological University at 1 site in Ireland.
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 1 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: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Isometric peak force during the isometric mid-thigh pull (time frame: Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.). The study lists 6 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 17 Feb 2020.