Myofascial Trigger Point PainNCT03941054
Myosfascial Trigger-Points and Effects on Neuromuscular Response
A study testing Pressure Release in people with Myofascial Trigger Point Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Pressure Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2019to 7 Jun 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjets with both active or latent Myosfascial Trigger Points
Who cannot join
- Pregnant women
- Musculoskeletal problems in the last month
- Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
- Psychological or nervous alterations
- Uncomprehension of the study protocol
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Treatment of Myosfascial Trigger-Points of Gastrocnemius and Its Effects on the Neuromuscular Response
The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Pressure Release
- 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.
Pressure ReleaseOther
Subjets receive digitopressure during 90 seconds for the treatment of the Myosfascial Trigger Points
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | No intervention |
| Pressure Release | Experimental | Digitopressure treatment of the Myosfascial Trigger Points Receives: Other: Pressure Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of neuromuscular stiffness of the gastrocnemious muscles
biomechanical property of a muscle that characterizes the resistance to an external force that deforms its initial shape, using a "Myoton".
Measured: 10 minutes before the intervention, and 1 minute after the intervention
change of elasticity of the gastrocnemious muscles
Biomechanical property of a muscle that characterizes the ability to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".
Measured: 10 minutes before the intervention, and 1 minute after the intervention
change of relaxation of the gastrocnemious muscles
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton".
Measured: 10 minutes before the intervention, and 1 minute after the intervention
Secondary outcomes (5)
change of active dorsiflexion ROM
Active range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
Measured: 4 minutes before the intervention, and 6 minute after the intervention
change of pasive dorsiflexion ROM
Pasive range of movement of the dorsiflexion of the ankle, using an inclinometer (degrees).
Measured: 2 minutes before the intervention, and 8 minute after the intervention
change of gastrocnemious strength
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Measured: 5 minutes before the intervention, and 5 minute after the intervention
change of pain intensity
How much pressure needs to be applied to cause pain
Measured: 8 minutes before the intervention, and 2 minute after the intervention
change of pressure-pain threshold
How much pain the pacient reports while a pressure of 1kg/cm²/s is being applied over his gastrocnemious muscle
Measured: 7 minutes before the intervention, and 3 minute after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start2 May 2019
- Primary completion7 Jun 2019 (estimated)
- Study completion7 Jun 2019 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 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
- Investigators
- Albert Pérez-Bellmunt, PhD, Principal investigator, Anatomy lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941054
- Sponsor's protocol ID
- Protocol ID : P3/03
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 7 May 2019
- 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Myosfascial Trigger-Points of Gastrocnemius and Its Effects on the Neuromuscular Response
- ClinicalTrials.gov ID
- NCT03941054
- Acronym / sponsor ID
- Protocol ID : P3/03
- Conditions
- Myofascial Trigger Point Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 7 Jun 2019 (estimated)
- Study completion
- 7 Jun 2019 (estimated)
- First posted
- 7 May 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.
The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –No intervention |
| Pressure Release | Experimental | Other: Pressure ReleaseDigitopressure treatment of the Myosfascial Trigger Points |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjets with both active or latent Myosfascial Trigger Points
Key exclusion criteria (5 listed)
- Pregnant women
- Musculoskeletal problems in the last month
- Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
- Psychological or nervous alterations
- Uncomprehension of the study protocol
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 |
|---|---|---|
| Pressure ReleaseSubjets receive digitopressure during 90 seconds for the treatment of the Myosfascial Trigger Points | Other | Pressure Release |
Primary outcome
change of neuromuscular stiffness of the gastrocnemious muscles
Time frame: 10 minutes before the intervention, and 1 minute after the intervention
biomechanical property of a muscle that characterizes the resistance to an external force that deforms its initial shape, using a "Myoton".
change of elasticity of the gastrocnemious muscles
Time frame: 10 minutes before the intervention, and 1 minute after the intervention
Biomechanical property of a muscle that characterizes the ability to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".
change of relaxation of the gastrocnemious muscles
Time frame: 10 minutes before the intervention, and 1 minute after the intervention
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton".
5 secondary outcomes
change of active dorsiflexion ROM
Time frame: 4 minutes before the intervention, and 6 minute after the intervention
change of pasive dorsiflexion ROM
Time frame: 2 minutes before the intervention, and 8 minute after the intervention
change of gastrocnemious strength
Time frame: 5 minutes before the intervention, and 5 minute after the intervention
change of pain intensity
Time frame: 8 minutes before the intervention, and 2 minute after the intervention
change of pressure-pain threshold
Time frame: 7 minutes before the intervention, and 3 minute after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- 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.
Albert Pérez-Bellmunt, PhD principal investigator
Anatomy lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Release 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 5 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 7 May 2019. 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?
Results are not available in the source record.
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?
change of neuromuscular stiffness of the gastrocnemious muscles (time frame: 10 minutes before the intervention, and 1 minute after the intervention). The study lists 3 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 7 May 2019.