Myofascial Trigger Point PainNCT04851743
Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in 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 80 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?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2021to 6 Jul 2021
- 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 80 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.
About this study
Official title: Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles: A Randomized Within-Participant Clinical Trial
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 neuromuscular function, pain perception, and basic physical properties in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle.
A randomized within-participant clinical trial with a blinded assessor will be conducted. 50 asymptomatic volunteers (100 gastrocnemius-muscle) with MrPs gastrocnemius-muscle TrPs will bilaterally explored. Each extremity will be randomly assigned to the control group (no treatment) or the experimental group (60 seconds of dry needling over each TrP). Neuromuscular function of the gastrocnemius muscle will be assessed using a MyotonPro and a tensiomyography. Muscle flexibility will be analyzed using the lunge test and the passive ankle range of motion. The strength will be determined with a handheld dynamometer (MicroFET2). Pain perception will be analyzed with a 0-to-10 numerical pain rating scale and determination of pressure pain thresholds over each latent TrP.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Dry needling
- Keywords
- dry needling, gastrocnemius, myofascial trigger point
- 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 experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling Group | Experimental | Participants will be used as their own controls, with 1 lower extremity randomly receiving intervention. The experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds. Receives: Other: Dry needling |
| Control Group | No intervention | Participants will be used as their own controls, with 1lower extremity randomly receiving intervention. The control extremity did not receive any intervention, and outcomes were assessed 2 minutes apart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Function (MyotonPro device) (Hz)
The Neuromuscular function will be assessed with a handheld MyotonPro myotonometry device, which will be placed on the skin, perpendicular to the surface of the belly of each gastrocnemius muscle, with the participant prone. The device will then lowered into the measurement position and held steady while it automatically conducted the predefined measurement series. The program consist of 3 single measurements with a recording interval of 1 second for each muscle. The average valuevfor each site will used in subsequent analyses. The reliability of the MyotonPro device has been reported to range from good to excellent (intraclass correlation coefficient = 0.8-0.93).
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Tensomyography (m/s)
The Tensomyography evaluation will be done by using a Dc-Dc Trans-Tek® transductor (GK 40, Panoptik d.o.o., Ljubliana, Slovenia) that will be perpendicularly placed to the gastrocnemius belly. Two self-adhesive electrodes (TMG electrodes, TMG-BMC d.o.o., Ljubljana, Slovenia) will be placed equidistant, proximal (anode) and distal (cathode) to the sensor, with an inter-electrode distance of 5 cm. Patient will be placed in prone position with a foam Electrical stimulation was applied through a TMG-100 System electrostimulator (TMG-BMCd.o.o., Ljubljana, Slovenia). The amplitude will be progressively increased from 20 to 100 mA by 20 mA increments until there will be no further increase in maximal radial displacement or maximal stimulator output was reached (i.e 110mA) (20). Ten seconds rest will be given between the stimuli to minimize the effects of fatigue and potentiation. The meters per second of muscle contraction with the electrical stimulus will be measured.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes (4)
Pressure Pain Threshold (Kg/cm2)
The pressure pain threshold is the amount of pressure that is first perceived as painful. In this study, it will be assessed over the gastrocnemius TrP with a handheld mechanical pressure algometer (Trigger Plus, Pal- patronic, Hagen, Germany). Pressure will be applied at a rate of 10 N/cm2/s until the participant first reported a painful sensation. This procedure has shown good intrarater reliability.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Pain with numerical pain rating scale
Participants will be also asked to rate their pain perception during the pressure pain threshold on an 11-point numerical pain rating scale (0 = no pain, 10 = maximum pain).
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Ankle Dorsiflexion Range of Motion (º)
Active ankle dorsiflexion range of motion will be assessed with the dorsiflexion lunge test. The test will be performed by placing the foot perpendicular to a wall and lunging the knee toward the wall. The foot will be moved further away from the wall until the maximum range of dorsiflexion was achieved. In order for the heel to not lift off of the floor, the examiner will place a band under the heel and applied tension.
The angulation from the tibia bone to the floor will be measured. The dorsiflexion lunge test has shown good intrarater and interrater reliability (intraclass correlation coefficient = 0.97).
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Muscle Strentch (Newtons)
A dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah) was used for isometric muscle-strength testing. All participants will barefoot during the testing procedure. Peak force will be measured by the dynamometer to the nearest 0.1 N. Contractions will be sustained for 3 seconds while the examiner applied unmoving resistance. Both gastrocnemius-testing will be repeated for 3 trials, with a 5-second rest between them. The mean of the 3 trials will be considered in the analysis.
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 posted20 Apr 2021
- Study start10 May 2021
- Primary completion1 Jul 2021
- Study completion6 Jul 2021
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 within-participant clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- NCT04851743
- Sponsor's protocol ID
- CBAS-2018-11B
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles: A Randomized Within-Participant Clinical Trial
- ClinicalTrials.gov ID
- NCT04851743
- Acronym / sponsor ID
- CBAS-2018-11B
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- dry needling, gastrocnemius, myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 20 Apr 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 neuromuscular function, pain perception, and basic physical properties in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle.
A randomized within-participant clinical trial with a blinded assessor will be conducted. 50 asymptomatic volunteers (100 gastrocnemius-muscle) with MrPs gastrocnemius-muscle TrPs will bilaterally explored. Each extremity will be randomly assigned to the control group (no treatment) or the experimental group (60 seconds of dry needling over each TrP). Neuromuscular function of the gastrocnemius muscle will be assessed using a MyotonPro and a tensiomyography. Muscle flexibility will be analyzed using the lunge test and the passive ankle range of motion. The strength will be determined with a handheld dynamometer (MicroFET2). Pain perception will be analyzed with a 0-to-10 numerical pain rating scale and determination of pressure pain thresholds over each latent TrP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized within-participant clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling Group | Experimental | Other: Dry needlingParticipants will be used as their own controls, with 1 lower extremity randomly receiving intervention. The experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds. |
| Control Group | No intervention | –Participants will be used as their own controls, with 1lower extremity randomly receiving intervention. The control extremity did not receive any intervention, and outcomes were assessed 2 minutes apart. |
Who may qualify
- Ages
- 18 to 80 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 experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds. | Other | Dry needling Group |
Primary outcome
Neuromuscular Function (MyotonPro device) (Hz)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
The Neuromuscular function will be assessed with a handheld MyotonPro myotonometry device, which will be placed on the skin, perpendicular to the surface of the belly of each gastrocnemius muscle, with the participant prone. The device will then lowered into the measurement position and held steady while it automatically conducted the predefined measurement series. The program consist of 3 single measurements with a recording interval of 1 second for each muscle. The average valuevfor each site will used in subsequent analyses. The reliability of the MyotonPro device has been reported to range from good to excellent (intraclass correlation coefficient = 0.8-0.93).
Tensomyography (m/s)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
The Tensomyography evaluation will be done by using a Dc-Dc Trans-Tek® transductor (GK 40, Panoptik d.o.o., Ljubliana, Slovenia) that will be perpendicularly placed to the gastrocnemius belly. Two self-adhesive electrodes (TMG electrodes, TMG-BMC d.o.o., Ljubljana, Slovenia) will be placed equidistant, proximal (anode) and distal (cathode) to the sensor, with an inter-electrode distance of 5 cm. Patient will be placed in prone position with a foam Electrical stimulation was applied through a TMG-100 System electrostimulator (TMG-BMCd.o.o., Ljubljana, Slovenia). The amplitude will be progressively increased from 20 to 100 mA by 20 mA increments until there will be no further increase in maximal radial displacement or maximal stimulator output was reached (i.e 110mA) (20). Ten seconds rest will be given between the stimuli to minimize the effects of fatigue and potentiation. The meters per second of muscle contraction with the electrical stimulus will be measured.
4 secondary outcomes
Pressure Pain Threshold (Kg/cm2)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Pain with numerical pain rating scale
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Ankle Dorsiflexion Range of Motion (º)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Muscle Strentch (Newtons)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
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 8 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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: finished, as of the sponsor's last update on 8 Jul 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. 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?
Neuromuscular Function (MyotonPro device) (Hz) (time frame: Change between baseline(immediately before intervention) and post intervention (immediately after 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 8 Jul 2021.