Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-31 @ 3:12 PM
Study NCT ID:
NCT05716204
Status:
UNKNOWN
Last Update Posted:
2023-11-30
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment expectancy and credibility', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Evaluated with Credibility and expectancy Questionaire (CEQ) in which the patient answer question related to the expectations of the intervention. Higher values mean better expectations on the therapy.'}, {'measure': 'Treatment expectancy and credibility', 'timeFrame': '3 months follow-up', 'description': 'Evaluated with Credibility and expectancy Questionaire (CEQ) in which the patient answer question related to the expectations of the intervention. Higher values mean better expectations on the therapy.'}], 'primaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'Baseline', 'description': 'Strength evaluate for internal and external hip rotators with a conical pulley.'}, {'measure': 'Strength', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Strength evaluate for internal and external hip rotators with a conical pulley.'}, {'measure': 'Strength', 'timeFrame': '3 months follow-up', 'description': 'Strength evaluate for internal and external hip rotators with a conical pulley.'}], 'secondaryOutcomes': [{'measure': 'Pain in sports activities', 'timeFrame': 'Baseline', 'description': 'Appearance time of pain during activities'}, {'measure': 'Pain in sports activities', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Appearance time of pain during activities'}, {'measure': 'Pain in sports activities', 'timeFrame': '3 months follow-up', 'description': 'Appearance time of pain during activities'}, {'measure': 'Pain intensity during/after pain provocation tests: Single adductor, squeeze and bilateral adductor tests', 'timeFrame': 'Baseline', 'description': 'Appearance of pain during or after the execution of Single adductor, squeeze and bilateral adductor tests. If pain appears it will be reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.'}, {'measure': 'Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Appearance of pain during or after the execution of Single adductor, squeeze and bilateral adductor tests. If pain appears it will be reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.'}, {'measure': 'Pain intensity after pain provocation tests: Single adductor, squeeze and bilateral adductor tests', 'timeFrame': '3 months follow-up', 'description': 'Appearance of pain during or after the execution of Single adductor, squeeze and bilateral adductor tests. If pain appears it will be reported by the patient using visual analog scale (VAS) from 0 to 10, in which higher scores are worse.'}, {'measure': 'Functional capacity', 'timeFrame': 'Baseline', 'description': 'Evaluated with a patient reported outcome questionnaire called Copenhagen Hip and Groin Outcome score (HAGOS) which assesses pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activities and hip and groin -related quality of life. For each item answer range from "never" to "always".'}, {'measure': 'Functional capacity', 'timeFrame': 'Through study completion, an average of two weeks', 'description': 'Evaluated with a patient reported outcome questionnaire called Copenhagen Hip and Groin Outcome score (HAGOS) which assesses pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activities and hip and groin -related quality of life. For each item answer range from "never" to "always".'}, {'measure': 'Functional capacity', 'timeFrame': '3 months follow-up', 'description': 'Evaluated with a patient reported outcome questionnaire called Copenhagen Hip and Groin Outcome score (HAGOS) which assesses pain, symptoms, physical function in daily living, physical function in sport and recreation, participation in physical activities and hip and groin -related quality of life. For each item answer range from "never" to "always".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteitis Pubis', 'Athletic Pubalgia']}, 'referencesModule': {'references': [{'pmid': '15679570', 'type': 'BACKGROUND', 'citation': 'Verrall GM, Slavotinek JP, Barnes PG, Fon GT. Description of pain provocation tests used for the diagnosis of sports-related chronic groin pain: relationship of tests to defined clinical (pain and tenderness) and MRI (pubic bone marrow oedema) criteria. Scand J Med Sci Sports. 2005 Feb;15(1):36-42. doi: 10.1111/j.1600-0838.2004.00380.x.'}, {'pmid': '21478502', 'type': 'BACKGROUND', 'citation': 'Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.'}, {'pmid': '11132119', 'type': 'BACKGROUND', 'citation': 'Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.'}]}, 'descriptionModule': {'briefSummary': 'Athletic osteitis pubis is a pathologic entity that can cause functional impairment. Scientific evidence have noticed that athletes experiment pain and a decrease on strength. Moreover, this symptomathology can affect daily life and functionality. There is no scientific evidence about the influence of manual therapy (MT) as a single treatment to improve this condition. The investigators decided to conduct a randomized controlled trial to compare the effects of a MT technique with placebo technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution.\n* Internal rotation ROM limited.\n* Positive provocation pain tests.\n\nExclusion Criteria:\n\n* Pain due to intraarticular hip pathology.\n* Hip pain due to inflamatory diseases.\n* Previous surgical interventions in hip, pelvis or lumbar spine.\n* MRI results or provocation pain tests inconcluyent'}, 'identificationModule': {'nctId': 'NCT05716204', 'briefTitle': 'Effects of Manual Therapy in Strenght, Pain and Functional Capacity for Sport Related Groin Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Valladolid'}, 'officialTitle': 'Effects on Pain, Strength and Functional Capacity of High Force Distraction of the Hip in Athletes With Osteitis Pubis.', 'orgStudyIdInfo': {'id': '067/229211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High force lateral distraction group', 'description': 'High force lateral distraction of the hip in maximun adjusted position.', 'interventionNames': ['Other: High force lateral distraction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo distraction group', 'description': 'Placebo lateral distraction of the affected hip in maximun adjusted position.', 'interventionNames': ['Other: Placebo distraction group']}], 'interventions': [{'name': 'High force lateral distraction', 'type': 'OTHER', 'description': 'High force lateral distraction on the affected hip.', 'armGroupLabels': ['High force lateral distraction group']}, {'name': 'Placebo distraction group', 'type': 'OTHER', 'description': 'Placebo lateral distraction on the affected hip.', 'armGroupLabels': ['Placebo distraction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42004', 'city': 'Soria', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Silvia Lahuerta Martín', 'geoPoint': {'lat': 41.76401, 'lon': -2.46883}}], 'centralContacts': [{'name': 'Silvia Lahuerta Martín', 'role': 'CONTACT', 'email': 'silvia.lahuerta@uva.es', 'phone': '+34 620431438'}], 'overallOfficials': [{'name': 'Silvia Lahuerta Martín', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Valladolid'}, {'name': 'Luis Ceballos Laita', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Valladolid'}, {'name': 'Sandra Jiménez del Barrio', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Valladolid'}, {'name': 'Maria Teresa Mingo Gómez', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Valladolid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valladolid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Silvia Lahuerta Martín', 'investigatorAffiliation': 'University of Valladolid'}}}}