Myofascial Trigger Point PainNCT04985578
Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles
A study testing Dry needling in people with Myofascial Trigger Point Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Trigger points (TrPs) are a common musculoskeletal cause of local and referred muscle pain, as well as local inflammation in the muscle and fascia. From a clinical and sensory viewpoint, TrPs may be classified as active or latent. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A TrP will be diagnosed using the following criteria: palpable taut band, presence of a painful spot in the taut band, and referred pain on palpation of the spot.
Who cannot join
- Participants were excluded if they reported any pain symptoms in the lower extremities in the previous year.
- They were also excluded if they presented previous surgical interventions, previous lower-extremity injury, any underlying medical disease, pregnancy, or muscle soreness after vigorous exercise.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional Catalunya
Barcelona, Sant Cugat, 08195
Jacobo Rodríguez-Sanz, Dr., 636136789 ext. +34, jrodriguez@uic.es
About this study
Trigger points (TrPs) are a common musculoskeletal cause of local and referred muscle pain, as well as local inflammation in the muscle and fascia. From a clinical and sensory viewpoint, TrPs may be classified as active or latent. The principal difference is the reproduction of symptoms experienced by an individual (active) with or without stimulation. Local and referred pain elicited from latent TrPs may be transient in duration upon stimulation, and latent TrPs may be present without spontaneous symptoms.
Both active and latent TrPs induce motor dysfunctions such as stiffness, restricted range of motion, and accelerated fatigability in the affected muscle. The interrater reliability of manual identification of latent TrPs in the calf muscles has been found to range from small to moderate. The clinical relevance of latent TrPs has increased in the last decade,4 and some studies have investigated the effects of treating them. Among all manual therapies targeted to latent TrPs, ischemic compression, or TrP pressure release, is the most commonly used. Although TrPs may affect any muscle, the gastrocnemius muscle may be the most susceptible in the lower extremity to developing them. It has been reported that 13% to 30% of the asymptomatic population has latent TrPs in these muscles, and their presence may affect sport practice.
Read more
The purpose of this study will be to evaluate changes in muscle activity in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle.
A randomized controlled clinical trial with blinded assessor will be conducted. 90 asymptomatic volunteers with MrPs gastrocnemius -muscle TrPs will bilaterally explored. After exploration the volunteer will be asigned to either Control (no treatment), experimental (60 seconds of dry needling on the TrP that refers more pain on the randomly assigned extremity) or sham group (60 seconds of dry needling on the TrP that refers more pain with a sham needle with no tip). To be part of the sham group patients should not have received any dry needling before.
Muscle activity is commonly recorded in research using surface electromyography (sEMG). sEMG has previously been used in similar studies because it is less invasive than intramuscular electromyography. Electromyography will be performed using the mDurance® surface electromyograph (mDurance Solutions SL; Granada, Spain) in order to capture muscle activity of the lateral and medial Gastrocnemius muscles (Electrodes will be placed as described by the mDurance application) during an unilateral countermovement Jump (in both extremities) and 20 meter Sprint. There will be a resting period of at least 2 minutes between exercises to prevent the results from being affected by fatigue.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Dry needling, Sham dry needling
- Keywords
- dry needling, gastrocnemius, myofascial trigger point, Superficial Electromyography
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds.
Sham dry needlingOther
The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds with a sham needle without tip.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling Group | Experimental | The experimental extremity will be assigned randomly and will receive a single treatment session of TrP dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds. Receives: Other: Dry needling |
| Sham dry needling | Placebo comparator | The experimental extremity will be assigned randomly and will receive a single treatment session of TrP sham dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, sham dry needling technique will be performed on the TrP for 60 seconds with a needle without tip. Receives: Other: Sham dry needling |
| Control | No intervention | No Treatment will be perfomed in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity (microVolts)
sEMG is a NON-invasive method that measures the electrical activity of the muscle generated by the passage of the nerve impulse, which causes depolarization of the muscle cell membrane during excitation. Once the muscle is contracted and receives electrical signals, the electrodes pick up these signals and record them on the device application.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes (2)
Jump Force (Newtons)
Jump Force will be measured using the Myjump app.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Jump Height (centimeters)
Jump Height will be measured using the Myjump app.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Sep 2021
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point PainStudies 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
- A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Pérez Bellmunt, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985578
- Sponsor's protocol ID
- CBAS-2018-11C
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles
- ClinicalTrials.gov ID
- NCT04985578
- Acronym / sponsor ID
- CBAS-2018-11C
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- dry needling, gastrocnemius, myofascial trigger point, Superficial Electromyography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
Trigger points (TrPs) are a common musculoskeletal cause of local and referred muscle pain, as well as local inflammation in the muscle and fascia. From a clinical and sensory viewpoint, TrPs may be classified as active or latent. The principal difference is the reproduction of symptoms experienced by an individual (active) with or without stimulation. Local and referred pain elicited from latent TrPs may be transient in duration upon stimulation, and latent TrPs may be present without spontaneous symptoms.
Both active and latent TrPs induce motor dysfunctions such as stiffness, restricted range of motion, and accelerated fatigability in the affected muscle. The interrater reliability of manual identification of latent TrPs in the calf muscles has been found to range from small to moderate. The clinical relevance of latent TrPs has increased in the last decade,4 and some studies have investigated the effects of treating them. Among all manual therapies targeted to latent TrPs, ischemic compression, or TrP pressure release, is the most commonly used. Although TrPs may affect any muscle, the gastrocnemius muscle may be the most susceptible in the lower extremity to developing them. It has been reported that 13% to 30% of the asymptomatic population has latent TrPs in these muscles, and their presence may affect sport practice.
The purpose of this study will be to evaluate changes in muscle activity in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle.
A randomized controlled clinical trial with blinded assessor will be conducted. 90 asymptomatic volunteers with MrPs gastrocnemius -muscle TrPs will bilaterally explored. After exploration the volunteer will be asigned to either Control (no treatment), experimental (60 seconds of dry needling on the TrP that refers more pain on the randomly assigned extremity) or sham group (60 seconds of dry needling on the TrP that refers more pain with a sham needle with no tip). To be part of the sham group patients should not have received any dry needling before.
Muscle activity is commonly recorded in research using surface electromyography (sEMG). sEMG has previously been used in similar studies because it is less invasive than intramuscular electromyography. Electromyography will be performed using the mDurance® surface electromyograph (mDurance Solutions SL; Granada, Spain) in order to capture muscle activity of the lateral and medial Gastrocnemius muscles (Electrodes will be placed as described by the mDurance application) during an unilateral countermovement Jump (in both extremities) and 20 meter Sprint. There will be a resting period of at least 2 minutes between exercises to prevent the results from being affected by fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling Group | Experimental | Other: Dry needlingThe experimental extremity will be assigned randomly and will receive a single treatment session of TrP dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds. |
| Sham dry needling | Placebo comparator | Other: Sham dry needlingThe experimental extremity will be assigned randomly and will receive a single treatment session of TrP sham dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, sham dry needling technique will be performed on the TrP for 60 seconds with a needle without tip. |
| Control | No intervention | –No Treatment will be perfomed in this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A TrP will be diagnosed using the following criteria: palpable taut band, presence of a painful spot in the taut band, and referred pain on palpation of the spot.
Key exclusion criteria (2 listed)
- Participants were excluded if they reported any pain symptoms in the lower extremities in the previous year.
- They were also excluded if they presented previous surgical interventions, previous lower-extremity injury, any underlying medical disease, pregnancy, or muscle soreness after vigorous exercise.
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 needlingThe therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds. | Other | Dry needling Group |
| Sham dry needlingThe therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds with a sham needle without tip. | Other | Sham dry needling |
Primary outcome
Muscle activity (microVolts)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
sEMG is a NON-invasive method that measures the electrical activity of the muscle generated by the passage of the nerve impulse, which causes depolarization of the muscle cell membrane during excitation. Once the muscle is contracted and receives electrical signals, the electrodes pick up these signals and record them on the device application.
2 secondary outcomes
Jump Force (Newtons)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Jump Height (centimeters)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
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 Myofascial Trigger Point Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Pérez-Bellmunt (636817297 ext. +34, aperez@uic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activity (microVolts) (time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)). 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 29 Sep 2021.