Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 3:16 PM
Study NCT ID:
NCT06499493
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2024-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-28', 'studyFirstSubmitDate': '2024-07-07', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles before intervention', 'timeFrame': 'Immediately before intervention.', 'description': 'The pressure at which the patient begins to feel pain with pressure is measured 3 times with an algometer. It is measured in newtons.'}, {'measure': '2.Pressure pain threshold in flexor digitorum brevis, biceps femoris, extensor digitorum brevis muscles after intervention', 'timeFrame': 'Immediately after the intervention.', 'description': 'The joint range is measured in dorsiflexion of the ankle joint with the knee extended under load and is measured with an inclinometer in degrees.Measured in grades.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastrocnemius muscle', 'range of motion', 'lower limb', 'therapeutics'], 'conditions': ['Myofascial Trigger Point', 'Gastrocnemius Muscle', 'Manual Therapy', 'Pain Threshold']}, 'descriptionModule': {'briefSummary': 'In the present study we will test the effects of myofascial induction technique in the muscles close to the application in the gastrocnemius muscle.', 'detailedDescription': 'In the present study we will test the effects of myofascial induction technique on nearby muscles. The calf maneuver proposed by Pilat for myofascial induction will be applied and the effects on the pain pressure threshold of the trigger points of the flexor digitorum brevis biceps femoris extensor digitorum longus muscles will be observed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subjects aged 18-39 years.\n* Healthy subjects with trigger point 1 of the gastrocnemius muscle in both lower limbs.\n\nExclusion criteria;\n\n* Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement and/or fasciitis.\n* History of lower limb surgery or history of lower limb injury with residual symptoms (pain or sensation of sensation) within the last year.\n* Participants could not have undergone ankle stretching or any other treatment.\n* Diabetes due to possible impaired distal arterial circulation.\n* Foot deformity, cavus and flat feet.\n* Foot deformities such as hammertoes and hallux valgus,\n* plantar calluses.\n* Dysfunction of the lower extremities or chronic injuries.'}, 'identificationModule': {'nctId': 'NCT06499493', 'briefTitle': 'Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius', 'organization': {'class': 'OTHER', 'fullName': 'Mayuben Private Clinic'}, 'officialTitle': 'Effects of Myofascial Induction Pressure Pain Threshold in Trigger Points of the Proximal Muscles of Gastrocnemius: A Prepost Study', 'orgStudyIdInfo': {'id': '2911202021420B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Myofascial induction in gastrocnemius', 'description': 'A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.', 'interventionNames': ['Other: Myofascial induction in gastrocnemius muscle']}], 'interventions': [{'name': 'Myofascial induction in gastrocnemius muscle', 'type': 'OTHER', 'description': 'A 3-pass shallow leg gliding technique was applied first, followed by 5 minutes of the deep myofascial calf induction technique described by Pilat.', 'armGroupLabels': ['Experimental: Myofascial induction in gastrocnemius']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28702', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Mayuben Clinic', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayuben Private Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist responsible area', 'investigatorFullName': 'EVA MARIA MARTÍNEZ JIMENEZ', 'investigatorAffiliation': 'Mayuben Private Clinic'}}}}