Clinical trial · Interventional
Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
NCT01403168CI-TRIAL-00018393OSTEOPATHIEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulties
Summary
Brief summary (as posted)
This is an open, prospective, controlled, randomized, comparative study with 2 arms. The purpose of the study is to assess the efficacy of osteopathy after breast surgery. 80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional analgesic treatments | Other | — | UNRESOLVED |
| OSTEOPATHY + conventional analgesic treatments | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * woman \>= 18 years * pain (median VAS \>=3 on the week prior to inclusion) * mastectomy or tumorectomy with axillary dissection \<= 12 months * PS \<=2 * able to write, understand and read French * signed informed consent Exclusion Criteria: * no pain * immediate breast reconstruction * history of cognitive or psychiatric troubles
References
Publications (13)
- BACKGROUNDFassoulaki 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 12351281
- BACKGROUNDIvens 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 1637663
- BACKGROUNDJung 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 12855309
- BACKGROUNDLabreze 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 17371770
- BACKGROUNDDirks 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 12218520
- BACKGROUNDEija 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 8740607
- BACKGROUNDAttal 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 17038030