Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology (OSTEOPATHIE)
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.
|Breast Cancer||Other: OSTEOPATHY + conventional analgesic treatments Other: Conventional analgesic treatments|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology|
- Efficacy of the osteopathy treatment on pain [ Time Frame: 3 months ]Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.
|Study Start Date:||April 2011|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: osteopathy + conventional analgesic treatments||
Other: OSTEOPATHY + conventional analgesic treatments
5 sessions for osteopathy are planned and will start in the 15 days following the enrollment.
The conventional analgesic treatments will be administered in the 15 days following the enrollment.
|Placebo Comparator: conventional analgesic treatments||
Other: Conventional analgesic treatments
These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403168
|Centre Leon Berard|
|LYON Cedex 08, France, 69373|
|Principal Investigator:||Gisele CHVETZOFF, MD||Centre Leon Berard|