- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06499441
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
San Sebastián De Los Reyes, Madrid, Spain, 28702
- Mayuben Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects from 18 to 39 years old.
- Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial induction in the gastrocnemius muscle
A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.
|
A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.
|
|
Active Comparator: Preassure release in gastrocnemius muscle
Also called ischaemic pressure.
Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure.
|
Also called ischaemic pressure.
Three cycles of pressure are applied to the trigger point of the gastrocnemius muscle until the pain disappears on pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Immediately before the intervention.
|
|
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
|
Immediately before the intervention.
|
|
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
|
Immediately before the intervention.
|
|
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
|
Immediately before the intervention.
|
|
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
|
Immediately before the intervention.
|
|
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
|
Immediately before the intervention.
|
|
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. |
Immediately before the intervention.
|
|
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. |
Immediately before the intervention.
|
|
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. |
Immediately after the intervention.
|
|
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. |
Immediately after the intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2911202021420C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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