Pain ThresholdNCT06499441
Comparative Effects of Myofascial Induction Therapy Versus Gastrocnemius Pressure Release Treatment on Trigger Point Pressure Pain Threshold in Proximal Muscles and Ankle Range of Motion.
A study testing Myofascial induction in gastrocnemius and Preassure release in people with Pain Threshold and Myofascial Trigger Point, run by Mayuben Private Clinic at 1 site in Spain.
Trial summary
The aim of the study is to test the effect of myofascial induction and pre-pressure release of the grastrocnemius muscle on the proximal musculature: biceps femoris, flexor digitorum brevis and extensor digitorum grandus on the pain pre-pressure threshold variable and range of motion of ankle with knee bend and flexed Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold, Myofascial Trigger Point, Manual Therapy
- What is being tested?
- Myofascial induction in gastrocnemius and Preassure release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2024to 3 Aug 2024
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects from 18 to 39 years old.
- Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs
Who cannot join
- Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement, and/or fasciitis
- History of lower limb surgery or history of lower-extremity injury with residual symptoms (pain or feeling of sensations) within the last year.
- Participants could not have undergone ankle stretching or any other treatment.
- Diabetes due to possible alteration of arterial distal circulation.
- Foot deformity, cavus, and flat feet.
- Foot deformities, such as hammer toes and hallux valgus,
- Plantar corns and calluses.
- Lower limb dysfunction or chronic injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Myofascial Induction Therapy Versus Gastrocnemius Pressure Release Treatment on Trigger Point Pressure Pain Threshold of the Biceps Femoris, Flexor Digitorum Brevis and Great Extensor Digitorum Muscles and Ankle ROM: Crossover Trial Study.
The aim of the study is to test the effect of myofascial induction and pre-pressure release of the grastrocnemius muscle on the proximal musculature: biceps femoris, flexor digitorum brevis and extensor digitorum grandus on the pain pre-pressure threshold variable and range of motion of ankle with knee bend and flexed
- Being tested
- Myofascial induction in gastrocnemius, Preassure release
- Keywords
- Fascia, myofascial trigger point, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial induction in gastrocnemiusOther
A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.
Preassure releaseOther
Also called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial induction in the gastrocnemius muscle | Experimental | A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat. Receives: Other: Myofascial induction in gastrocnemius |
| Preassure release in gastrocnemius muscle | Active comparator | Also called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure. Receives: Other: Preassure release |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Threshold of pain on pressure on biceps femoris before.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
2.Pain threshold to pressure in the extensor digitorum longus muscle before.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
3.Pain threshold to pressure on flexor digitorum brevis muscle before.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
4.Pain threshold on biceps femoris pressure after.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
5.Pain threshold to pressure in the extensor digitorum longus muscle after.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
6.Pain threshold on pressure in the flexor digitorum brevis muscle tras.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
Measured: Immediately before the intervention.
7. Ankle range of motion with knee extended before intervention
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees.
measured in degrees.
Measured: Immediately before the intervention.
8. Ankle range of motion with knee flexed before intervention
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees.
measured in degrees.
Measured: Immediately before the intervention.
9. Ankle range of motion with knee extended after intervention
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees.
measured in degrees.
Measured: Immediately after the intervention.
10. Ankle range of motion with knee flexed after intervention
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees.
measured in degrees.
Measured: Immediately 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 posted12 Jul 2024
- Study start22 Jul 2024
- Primary completion24 Jul 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ThresholdStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayuben Private Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499441
- Sponsor's protocol ID
- 2911202021420C
- Status last verified
- Aug 2024
- First submitted
- 7 Jul 2024
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Myofascial Induction Therapy Versus Gastrocnemius Pressure Release Treatment on Trigger Point Pressure Pain Threshold of the Biceps Femoris, Flexor Digitorum Brevis and Great Extensor Digitorum Muscles and Ankle ROM: Crossover Trial Study.
- ClinicalTrials.gov ID
- NCT06499441
- Acronym / sponsor ID
- 2911202021420C
- Keywords
- Fascia, myofascial trigger point, lower limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayuben Private ClinicUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 12 Jul 2024 (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 the study is to test the effect of myofascial induction and pre-pressure release of the grastrocnemius muscle on the proximal musculature: biceps femoris, flexor digitorum brevis and extensor digitorum grandus on the pain pre-pressure threshold variable and range of motion of ankle with knee bend and flexed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial induction in the gastrocnemius muscle | Experimental | Other: Myofascial induction in gastrocnemiusA 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat. |
| Preassure release in gastrocnemius muscle | Active comparator | Other: Preassure releaseAlso called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects from 18 to 39 years old.
- Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs
Key exclusion criteria (8 listed)
- Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement, and/or fasciitis
- History of lower limb surgery or history of lower-extremity injury with residual symptoms (pain or feeling of sensations) within the last year.
- Participants could not have undergone ankle stretching or any other treatment.
- Diabetes due to possible alteration of arterial distal circulation.
- Foot deformity, cavus, and flat feet.
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 |
|---|---|---|
| Myofascial induction in gastrocnemiusA 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat. | Other | Myofascial induction in the gastrocnemius muscle |
| Preassure releaseAlso called ischaemic pressure. Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure. | Other | Preassure release in gastrocnemius muscle |
Primary outcome
1.Threshold of pain on pressure on biceps femoris before.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
2.Pain threshold to pressure in the extensor digitorum longus muscle before.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
3.Pain threshold to pressure on flexor digitorum brevis muscle before.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
4.Pain threshold on biceps femoris pressure after.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
5.Pain threshold to pressure in the extensor digitorum longus muscle after.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
6.Pain threshold on pressure in the flexor digitorum brevis muscle tras.
Time frame: Immediately before the intervention.
The pressure at which the patient starts to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons
7. Ankle range of motion with knee extended before intervention
Time frame: Immediately before the intervention.
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees. measured in degrees.
8. Ankle range of motion with knee flexed before intervention
Time frame: Immediately before the intervention.
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees. measured in degrees.
9. Ankle range of motion with knee extended after intervention
Time frame: Immediately after the intervention.
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees. measured in degrees.
10. Ankle range of motion with knee flexed after intervention
Time frame: Immediately after the intervention.
The joint amplitude is measured in dorsiflexion of the ankle joint with the knee flexed under load and is measured with an inclinometer in degrees. measured in degrees.
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 6 Aug 2024.
- 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 Myofascial induction in gastrocnemius and Preassure release in people with Pain Threshold and Myofascial Trigger Point, run by Mayuben Private Clinic 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 2 inclusion and 8 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 6 Aug 2024. 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?
1.Threshold of pain on pressure on biceps femoris before. (time frame: Immediately before the intervention.). The study lists 10 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 6 Aug 2024.