Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-01 @ 1:11 PM
Study NCT ID:
NCT05193695
Status:
TERMINATED
Last Update Posted:
2022-01-31
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'full sample size', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-15', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived pain intensity', 'timeFrame': 'Change from baseline (baseline and immediately after treatment)', 'description': 'Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.'}, {'measure': 'Ankle Range of Motion (ROM)', 'timeFrame': 'Change from baseline (baseline and immediately after treatment)', 'description': 'It is the degree of angular movement allowed by the ankle joint measured by kinovea.'}], 'secondaryOutcomes': [{'measure': 'Muscular strength of triceps sural', 'timeFrame': 'Change from baseline (baseline and immediately after treatment)', 'description': 'By means of the heel rise test, the patient must perform a bipodal plantiflexion measured in the maximum number of repetitions in 30 seconds.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Humans', 'Excercise therapy', 'Hot temperature', 'Post dry needling', 'Range of motion, articular', 'Muscle Strength'], 'conditions': ['Physical Therapy Modalities', 'Pain Measurement', 'Trigger Point Pain, Myofascial', 'Ankle Fractures', 'Rehabilitation', 'Needles']}, 'descriptionModule': {'briefSummary': 'Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 18 and 60 years of age.\n* Man or woman.\n* At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.\n* Perform full load without using technical aids.\n\nExclusion Criteria:\n\n* Use of analgesics.\n* Insurmountable fear of needles.\n* Immune disease.\n* Clotting disorders.\n* Sensory disorders.\n* Psychiatric / psychological illness.\n* Cancer.\n* Rheumatic diseases.'}, 'identificationModule': {'nctId': 'NCT05193695', 'briefTitle': 'How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients', 'organization': {'class': 'OTHER', 'fullName': 'Becerra, Pablo'}, 'officialTitle': 'Heat or Excesice in Treadmill as Techique to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients', 'orgStudyIdInfo': {'id': 'Becerra'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients remained in the supine position for 20 minutes lying on a stretcher after dry needling.'}, {'type': 'EXPERIMENTAL', 'label': 'Treadmill', 'description': 'The patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002).', 'interventionNames': ['Other: Treadmill exercise']}], 'interventions': [{'name': 'Treadmill exercise', 'type': 'OTHER', 'otherNames': ['Treadmill after dry needling'], 'description': 'the patients walked on a treadmill for 20 minutes after dry needling, with an inclination of 5 degrees and at a speed at which the perceived exertion was 5 according to the Borg CR10 scale (Chen et al., 2002)', 'armGroupLabels': ['Treadmill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380419', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Complejo Hospitalario San Jose', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becerra, Pablo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical therapist', 'investigatorFullName': 'Pablo Yañez Becerra', 'investigatorAffiliation': 'Becerra, Pablo'}}}}