Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06248905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shock Wave Therapy Plus Exercise in GTPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS Pain', 'timeFrame': '6 months', 'description': 'Change in lateral hip pain measured by the Numeric Rating Scale (NRS)'}], 'secondaryOutcomes': [{'measure': 'EQ5D Quality of life', 'timeFrame': '12 months', 'description': 'Change in quality of life measured by EQ-5D-3L'}, {'measure': 'VISA-G Disability', 'timeFrame': '12 months', 'description': 'Change in disability measured by VISA-G questionnaire'}, {'measure': 'Functional capacity (strength of gluteal muscles)', 'timeFrame': '12 months', 'description': 'Change in functional capacity measured by MRC scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Greater Trochanteric Pain Syndrome of Both Lower Limbs']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral hip pain of four weeks or longer duration\n* Pain to palpation in the greater trochanteric area at physical examination\n* Pain in hip end-range abduction/rotation/adduction at physical examination\n* Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons\n* Adult age and written informed consent\n\nExclusion Criteria:\n\n* No hip osteoarthritis, diagnosed according to Altman's criteria\n* No history of knee osteoarthritis\n* No history of rheumatologic diseases\n* No previous fractures or surgery in the affected limb\n* No clinical signs of lumbar radiculopathy at physical examination\n* No corticosteroid injections, since the onset of the current pain episode\n* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)"}, 'identificationModule': {'nctId': 'NCT06248905', 'acronym': 'GTPSSWEX', 'briefTitle': 'Shock Wave Therapy Plus Exercise in GTPS', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0005201/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise plus shockwaves', 'description': 'Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator.\n\nFocusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus.\n\nDosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz).\n\nThe experimental group will then start a physiotherapy program for the following 8 weeks. The program is made up of strengthening and stretching exercises of gluteal muscles, planned to be daily performed at home. Four supervised physiotherapy session will be planned on week 0-1-2-4, during which the exercise loading will be implemented.', 'interventionNames': ['Other: Rehabilitation program based on the strengthening of gluteal muscles', 'Other: Extracorporeal shock wave therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'shockwaves', 'description': 'Enrolled subject will be treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician, using a device powered by an electromagnetic generator.\n\nFocusing: (out-of-line) ultrasound-guided with the patient lying in lateral decubitus.\n\nDosimetry: 1500-1800 shots per session with an energy flux density equal to 0.10-0.20 mJ/mm2 (frequency=4Hz).', 'interventionNames': ['Other: Extracorporeal shock wave therapy']}], 'interventions': [{'name': 'Rehabilitation program based on the strengthening of gluteal muscles', 'type': 'OTHER', 'description': 'Physiotherapy program (8 weeks)', 'armGroupLabels': ['exercise plus shockwaves']}, {'name': 'Extracorporeal shock wave therapy', 'type': 'OTHER', 'description': 'Focused shock wave therapy (3 weeks)', 'armGroupLabels': ['exercise plus shockwaves', 'shockwaves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medicine Doctor', 'investigatorFullName': 'Ettore Carlis', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}