Myofascial Pain SyndromeNCT03963674
Effects of Diacutaneous Fibrolysis Over Neuromuscular Response
A study testing Diacutaneous fibrolysis in people with Myofascial Pain Syndrome and Contraction, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain Syndrome, Contraction
- What is being tested?
- Diacutaneous fibrolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2019to 5 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
None listed.
Who cannot join
- Muscle injury in the last two months
- To not understand the study orders
- Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.
- Conditions
- Myofascial Pain Syndrome, Contraction
- Being tested
- Diacutaneous fibrolysis
- Keywords
- Neuromuscular response, diacutaneous fibrolysis
- 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.
Diacutaneous fibrolysisOther
Diacutaneous fibrolysis over the gastrocnemious muscles
| Study group | Role | What they receive |
|---|---|---|
| Diacutaneous fibrolysis | Experimental | Not described Receives: Other: Diacutaneous fibrolysis |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay time change
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Contraction time change
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Sustain time change
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Measured: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Relaxation time change
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Measured: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Maximal displacement change
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
Measured: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Stiffness change
Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).
Measured: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Elasticity change
Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).
Measured: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Relaxation change
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
Measured: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Secondary outcomes (1)
Gastrocnemious strength change
Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).
Measured: 8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start5 Feb 2019
- Primary completion5 Feb 2019
- Study completion5 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 Pain SyndromeStudies 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
- 30 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
- NCT03963674
- Sponsor's protocol ID
- Protocol 5
- Status last verified
- Feb 2019
- First submitted
- 20 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
- ClinicalTrials.gov ID
- NCT03963674
- Acronym / sponsor ID
- Protocol 5
- Conditions
- Myofascial Pain Syndrome, Contraction
- Keywords
- Neuromuscular response, diacutaneous fibrolysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Jun 2019 (estimated)
- First posted
- 28 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 study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diacutaneous fibrolysis | Experimental | Other: Diacutaneous fibrolysis |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Muscle injury in the last two months
- To not understand the study orders
- Suffer a musculoskeletal disorder that doesn't allow the subject to do 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 |
|---|---|---|
| Diacutaneous fibrolysisDiacutaneous fibrolysis over the gastrocnemious muscles | Other | Diacutaneous fibrolysis |
Primary outcome
Delay time change
Time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Contraction time change
Time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).
Sustain time change
Time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Relaxation time change
Time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).
Maximal displacement change
Time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later
Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).
Stiffness change
Time frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).
Elasticity change
Time frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).
Relaxation change
Time frame: 2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later
Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).
1 secondary outcome
Gastrocnemious strength change
Time frame: 8 minutes before the intervention, 1 minute after the intervention and 30 minutes later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
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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 Diacutaneous fibrolysis in people with Myofascial Pain Syndrome and Contraction, 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 0 inclusion and 3 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 28 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?
Delay time change (time frame: 4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later). The study lists 8 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 28 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.