Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 2:41 PM
Study NCT ID:
NCT03440957
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Decrease in analgesic consumption for pain related to immobilization', 'timeFrame': '15 days'}, {'measure': 'Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).', 'timeFrame': '15 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advanced cancer', 'osteopathy', 'pain', 'bedridden'], 'conditions': ['Cancer Patient Confined in the Bed']}, 'descriptionModule': {'briefSummary': 'Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman\n* Aged 18 years or older\n* Having signed informed consent to participate in the study\n* Patient affiliated to a social security scheme\n* Patient with pain affecting the musculoskeletal system following prolonged bed rest\n* Capable to understand French\n* Capable of completing self-assessment scales\n\nExclusion Criteria:\n\n* Patients with bone metastases at risk for the use of osteopathy\n* Patients under legal protection measures\n* Patients with cognitive impairment preventing self-evaluation\n* Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study\n* Patients in the pre-agonic or agonic phase'}, 'identificationModule': {'nctId': 'NCT03440957', 'acronym': 'OSTEO', 'briefTitle': 'Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study', 'orgStudyIdInfo': {'id': '69HCL17_0723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Osteopathy treatment', 'interventionNames': ['Other: Osteopathic treatment']}], 'interventions': [{'name': 'Osteopathic treatment', 'type': 'OTHER', 'description': 'The patients meeting the inclusions criteria will be informed of the study and an osteopathic treatment holistic ,involving all the body will be applied, three time with 2 days between the treatments .Each meeting with the practitioner will last around 40 minutes. The pain and symptoms assessment will be done before and after the treatment .', 'armGroupLabels': ['Osteopathy treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hôpital Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Marilène FILBET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}