Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT06669858
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000844', 'term': 'Ankylosis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analogic Visual Scale of pain', 'timeFrame': 'at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery', 'description': 'Pain scale from 0 (no pain) to 10 (maximal pain).'}], 'secondaryOutcomes': [{'measure': 'OSWESTRY', 'timeFrame': 'day 0 pre surgery - day 90 post surgery - day 105 post surgery', 'description': 'quality of life questionnary to evaluate fonctional incapacity. Score from 0 (no invalidity) to 50 (complete invalidity)'}, {'measure': 'Hospital Anxiety and Depression', 'timeFrame': 'day 0 pre surgery, day 90 post surgery', 'description': 'questionnary about depression and anxiety during hospitalisation. Score from 0 (no trouble) to 21 (severe trouble)'}, {'measure': 'Antalgic consumption', 'timeFrame': 'from day 0 to day 105', 'description': 'week table of antalgic consumption'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthrodesis', 'Post-operative Care', 'Manual Therapy', 'Lumbar Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having surgery in Institut de la Colonne Vertébrale\n* surgery of lumbosacral arthrodesis\n\nExclusion Criteria:\n\n* spine deformation\n* inflammatory rhumatim\n* neurodegenerative pathology\n* cognitive trouble\n* neoplasic pathology\n* surgery complication\n* second surgery\n* out of the study'}, 'identificationModule': {'nctId': 'NCT06669858', 'briefTitle': 'Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis', 'organization': {'class': 'OTHER', 'fullName': "Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon"}, 'officialTitle': 'Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study', 'orgStudyIdInfo': {'id': '2024/0219L10/0219L17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual therapy standardized protocol group', 'description': 'This arm received 2 session of manual therapy (standardized protocol) 2-4 days after surgery and 90 days after surgery', 'interventionNames': ['Other: manual therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham protocol group', 'description': 'The sham group received a standardized protocol of ligth touch with wide pressure of the 2 hands, without intention to treat.', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'manual therapy', 'type': 'OTHER', 'description': 'In first session 6 techniques were applied to favorise fluids circulation, respiratory mecanism end equilibration of pressions (all were external soft tissue techniques, without manipulation): on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on liver and spleen organ, on lumbar fasciae.\n\nIn second session 6 techniques were applied in order to improve quality and quantity of legs and pelvis mobility (all were external sof tissue techniques, without manipulation) : on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on pubic symphysis, on legs and pelvis and on lumbar fasciae', 'armGroupLabels': ['Manual therapy standardized protocol group']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90', 'armGroupLabels': ['Sham protocol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69110', 'city': 'Ste Foy Les Lyons', 'country': 'France', 'facility': 'Institut de la Colonne Vertébrale Lyon Charcot'}], 'overallOfficials': [{'name': 'Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO', 'role': 'STUDY_DIRECTOR', 'affiliation': "Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon"}, {'name': 'Pierre Grobost, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut de la Colonne Vertébrale Lyon Charcot'}, {'name': 'Aline Rollet, Ostéopathe DO, MsC Cand.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'beginning 3 months and ending 3 years after publication of results', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'on demand near to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon", 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de la Colonne Vertébrale Lyon Charcot', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}