Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT04097392
Status:
UNKNOWN
Last Update Posted:
2019-09-20
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm muscle thickness', 'timeFrame': 'Change from Baseline diaphragm muscle thickness at 8 weeks', 'description': 'Diaphragm muscle thickness evaluated in centimeters by ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Change from Baseline pressure pain threshold at 8 weeks', 'description': 'Pressure pain threshold evaluated in kilograms / squared centimeter by algometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasonography', 'Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '30954705', 'type': 'BACKGROUND', 'citation': 'Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.'}, {'pmid': '30545067', 'type': 'BACKGROUND', 'citation': 'Calvo-Lobo C, Painceira-Villar R, Lopez-Lopez D, Garcia-Paz V, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P. Tarsal Tunnel Mechanosensitivity Is Increased in Patients with Asthma: A Case-Control Study. J Clin Med. 2018 Dec 12;7(12):541. doi: 10.3390/jcm7120541.'}, {'pmid': '28272251', 'type': 'BACKGROUND', 'citation': 'Calvo-Lobo C, Diez-Vega I, Martinez-Pascual B, Fernandez-Martinez S, de la Cueva-Reguera M, Garrosa-Martin G, Rodriguez-Sanz D. Tensiomyography, sonoelastography, and mechanosensitivity differences between active, latent, and control low back myofascial trigger points: A cross-sectional study. Medicine (Baltimore). 2017 Mar;96(10):e6287. doi: 10.1097/MD.0000000000006287.'}]}, 'descriptionModule': {'briefSummary': 'Objective: To determine the effectiveness of diaphragm biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Athletes with non-specific lumbopelvic pain during 6 weeks\n\nExclusion Criteria:\n\n* Neural disorders\n* Systemic disorders\n* Cognitive disorders'}, 'identificationModule': {'nctId': 'NCT04097392', 'briefTitle': 'Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de León'}, 'officialTitle': 'Effectiveness of Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumpo-pelvic Pain', 'orgStudyIdInfo': {'id': 'UCM PR65/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diaphragm biofeedback reeducation plus inspiratory training', 'interventionNames': ['Other: Experimental']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isolated high-intensity inspiratory muscle training', 'interventionNames': ['Other: Active comparator']}], 'interventions': [{'name': 'Experimental', 'type': 'OTHER', 'description': 'Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks', 'armGroupLabels': ['Diaphragm biofeedback reeducation plus inspiratory training']}, {'name': 'Active comparator', 'type': 'OTHER', 'description': 'Isolated high-intensity inspiratory muscle training during 8 weeks', 'armGroupLabels': ['Isolated high-intensity inspiratory muscle training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'César Calvo Lobo, PhD', 'role': 'CONTACT', 'email': 'cescalvo@ucm.es', 'phone': '0034 913 94 15 36'}], 'facility': 'Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'César Calvo Lobo, PhD', 'role': 'CONTACT', 'email': 'cescalvo@ucm.es', 'phone': '0034 913 94 15 36'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de León', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'César Calvo Lobo', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}