Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-13 @ 11:16 PM
Study NCT ID:
NCT01403168
Status:
TERMINATED
Last Update Posted:
2015-06-29
First Post:
2011-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-26', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the osteopathy treatment on pain', 'timeFrame': '3 months', 'description': 'Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteopathy', 'Breast cancer', 'Pain'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '12351281', 'type': 'BACKGROUND', 'citation': 'Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents. doi: 10.1097/00000539-200210000-00036.'}, {'pmid': '1637663', 'type': 'BACKGROUND', 'citation': 'Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8. doi: 10.1038/bjc.1992.230.'}, {'pmid': '12855309', 'type': 'BACKGROUND', 'citation': 'Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. doi: 10.1016/s0304-3959(03)00241-0. No abstract available.'}, {'pmid': '17371770', 'type': 'BACKGROUND', 'citation': 'Labreze L, Dixmerias-Iskandar F, Monnin D, Bussieres E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. French.'}, {'pmid': '12218520', 'type': 'BACKGROUND', 'citation': 'Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.'}, {'pmid': '8740607', 'type': 'BACKGROUND', 'citation': 'Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.'}, {'pmid': '17038030', 'type': 'BACKGROUND', 'citation': 'Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.'}, {'pmid': '8838907', 'type': 'BACKGROUND', 'citation': 'Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. doi: 10.7556/jaoa.1996.96.2.113.'}, {'pmid': '12041633', 'type': 'BACKGROUND', 'citation': 'Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. doi: 10.5694/j.1326-5377.2002.tb04459.x.'}, {'pmid': '12532139', 'type': 'BACKGROUND', 'citation': 'Licht PB, Christensen HW, Hoilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52. doi: 10.1067/mmt.2003.42.'}, {'pmid': '10541511', 'type': 'BACKGROUND', 'citation': 'Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. doi: 10.1136/bmj.319.7218.1176. No abstract available.'}, {'pmid': '15083985', 'type': 'BACKGROUND', 'citation': 'Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.'}, {'pmid': '17122030', 'type': 'BACKGROUND', 'citation': 'Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.'}]}, 'descriptionModule': {'briefSummary': 'This is an open, prospective, controlled, randomized, comparative study with 2 arms.\n\nThe purpose of the study is to assess the efficacy of osteopathy after breast surgery.\n\n80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* woman \\>= 18 years\n* pain (median VAS \\>=3 on the week prior to inclusion)\n* mastectomy or tumorectomy with axillary dissection \\<= 12 months\n* PS \\<=2\n* able to write, understand and read French\n* signed informed consent\n\nExclusion Criteria:\n\n* no pain\n* immediate breast reconstruction\n* history of cognitive or psychiatric troubles'}, 'identificationModule': {'nctId': 'NCT01403168', 'acronym': 'OSTEOPATHIE', 'briefTitle': 'Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology', 'orgStudyIdInfo': {'id': 'OSTEOPATHIE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'osteopathy + conventional analgesic treatments', 'interventionNames': ['Other: OSTEOPATHY + conventional analgesic treatments']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'conventional analgesic treatments', 'interventionNames': ['Other: Conventional analgesic treatments']}], 'interventions': [{'name': 'OSTEOPATHY + conventional analgesic treatments', 'type': 'OTHER', 'description': '5 sessions for osteopathy are planned and will start in the 15 days following the enrollment.\n\nThe conventional analgesic treatments will be administered in the 15 days following the enrollment.', 'armGroupLabels': ['osteopathy + conventional analgesic treatments']}, {'name': 'Conventional analgesic treatments', 'type': 'OTHER', 'description': 'These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.', 'armGroupLabels': ['conventional analgesic treatments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Gisele CHVETZOFF, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}