Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06802120
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2025-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability will be assessed using the ODQ', 'timeFrame': 'baseline and Week 8', 'description': 'Oswestry Low Back Pain Disability Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Pain and disability measures', 'timeFrame': 'baseline, ans every week from 1 to 8', 'description': 'visual analogue scale of pain'}, {'measure': 'The Osteopathic Dysfunction Palpation Assessment Scale', 'timeFrame': 'baseline and Week 8', 'description': 'Osteopathic Dysfunction Palpation Assessment Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chirurgical Intervention']}, 'descriptionModule': {'briefSummary': "The aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. This study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management.\n\nFor this purpose, We will analyze the effects of these two approaches, targeted and non-targeted osteopathy (TO vs. NTO), on patients' disability and quality of life after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion\n* being under a stable pharmacological treatment over the last month\n* who are suffering from postoperative mechanical pain (VAS ≥ 4)\n\nExclusion Criteria:\n\n* neuropathic pain according to a DN4 score greater than or equal to 4/10,\n* are suffering from fibromyalgia,\n* algodystrophy,\n* other somatic or neuropsychiatric diseases (other than depression and anxiety),\n* have received osteopathic treatment over the last three month prior to inclusion,\n* are included in another interventional research protocol during the study period'}, 'identificationModule': {'nctId': 'NCT06802120', 'acronym': 'OSTEODESE', 'briefTitle': 'Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Bizet'}, 'officialTitle': 'Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY', 'orgStudyIdInfo': {'id': '2024-A01768-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted osteopathic treatment', 'description': 'treatment with real osteopathy', 'interventionNames': ['Other: osteopathy real']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-targeted osteopathic treatment', 'description': 'treatment with sham osteopathy', 'interventionNames': ['Other: sham osteopathy']}], 'interventions': [{'name': 'osteopathy real', 'type': 'OTHER', 'description': 'treatment with real osteopathy 2 times a week for 8 weeks', 'armGroupLabels': ['Targeted osteopathic treatment']}, {'name': 'sham osteopathy', 'type': 'OTHER', 'description': 'treatment with sham osteopathy 2 times a week for 8 weeks', 'armGroupLabels': ['Non-targeted osteopathic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75116', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'bouchra Benkessou, PM', 'role': 'CONTACT', 'email': 'b.benkessou@hexagone-sante-paris.fr', 'phone': '0764486016'}, {'name': 'Georges ABI LAHOUD, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Bizet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Bouchra benkessou, PM', 'role': 'CONTACT', 'email': 'b.benkessou@hexagone-sante-paris.fr', 'phone': '0033140693525'}, {'name': 'Georges ABI LAHOUD, Professeur', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Bizet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut De La Colonne Vertebrale Et Des Neurosciences', 'class': 'OTHER'}, {'name': "Ecole Supérieur d'Ostéopathie", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}