Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-29 @ 7:01 AM
Study NCT ID:
NCT03867292
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrotherapy and Myofascial Therapy in Padel Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089803', 'term': 'Myofascial Release Therapy'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline low back flexion after treatment and at a month', 'timeFrame': 'Screening visit, within the first seven days after treatment and after one month follow-up visit', 'description': 'Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline low back extension after treatment and at a month', 'timeFrame': 'Screening visit, within the first seven days after treatment and after one month follow-up visit', 'description': 'Low back extension will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to lean back to the maximum, keeping the knees extended. When the maximum extension is reached, the decrease in the distance between the skin marks will be measured. The unit of measurement is the centimeter (at a lower distance, greater mobility in extension of the lumbar spine).'}, {'measure': 'Change from baseline low back flexion after treatment and at a month', 'timeFrame': 'Screening visit, within the first seven days after treatment and after one month follow-up visit', 'description': 'Low back flexion will be measured with the Fingertip-to-floor test. With the subject standing on a platform 20 cm high (without shoes and with their feet together), you will be asked to lean towards flexion, while keeping your knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform shall be measured with a flexible measuring tape and expressed in centimeters. The vertical distance (measured in centimeters) between the platform and the tip of the middle finger will be positive when the subject does not reach the platform and negative when it can go further.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paddle-tennis', 'Myofascial release', 'Electrotherapy', 'Physiotherapy', 'Low back', 'Randomized clinical trial'], 'conditions': ['Low Back Pain, Mechanical']}, 'descriptionModule': {'briefSummary': 'Introduction. The lumbar region is one of the locations with the highest incidence of injuries in the paddle players. The crossed hands myofascial technique is used to release the restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy technique of TENS consists in the application of a low frequency current for the recovery, capitalization and oxygenation of the muscle, thus improving mobility and pain.\n\nAim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated players.\n\nStudy design. Randomized, multicenter, simple blind, clinical trial with follow-up period.\n\nMethods. 30 players paddle will be assigned to the two study groups: experimental (intervention through therapy myofascial and electrotherapy) and control (intervention by electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week, lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and follow-up. The variable of study is the mobility of the lumbar spine in the movements of flexion and extension (assessed by the employment of tests of Schober and Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and in case of homogeneity of the groups is used in parametric tests: test t-student for paired data (difference between the different assessments) and ANOVA of mean repeated (intra-and intersujeto).\n\nExpected results. Improvement of the mobility of the lumbar spine in the movements of flexion and extension.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Padel players\n* With federal sheet\n* Male\n* Over 18 years\n* Currently participate in regional and / or national competitions\n\nExclusion Criteria:\n\n* Present a medical diagnosis of musculoskeletal pathology\n* Not signed the informed consent document.'}, 'identificationModule': {'nctId': 'NCT03867292', 'briefTitle': 'Electrotherapy and Myofascial Therapy in Padel Players', 'organization': {'class': 'NETWORK', 'fullName': 'Investigación en Hemofilia y Fisioterapia'}, 'officialTitle': 'Efficacy of a Physiotherapy Intervention by Electrotherapy Combined With Myofascial Therapy for the Improvement of Lumbar Region Mobility in Federated Padel Players. A Pilot Study', 'orgStudyIdInfo': {'id': 'MIOTENS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial', 'description': 'The subjects that include the experimental group will receive an intervention through myofascial therapy of crossed hands and electrotherapy', 'interventionNames': ['Other: Myofascial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Electrotherapy', 'description': 'The subjects that are included in the experimental group will receive an intervention through electrotherapy', 'interventionNames': ['Other: Electrotherapy']}], 'interventions': [{'name': 'Myofascial', 'type': 'OTHER', 'description': 'The aim of the application of the crossed hands technique is to produce a deep fascial release, placing the subject in prone position, while the standing physiotherapist will contact with one hand on the spine at the level of the thoracolumbar hinge and with the other hand on the sacrum, so that the hands are crisscrossed. The crossed hands technique will be performed between 90 seconds and 5 minutes.\n\nThe application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.', 'armGroupLabels': ['Myofascial']}, {'name': 'Electrotherapy', 'type': 'OTHER', 'description': 'The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.', 'armGroupLabels': ['Electrotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Madrid', 'state': 'Comunity of Madrid', 'country': 'Spain', 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Europea de Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Investigación en Hemofilia y Fisioterapia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}