Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology (OSTEOPATHIE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01403168|
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : July 27, 2011
Last Update Posted : June 29, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: OSTEOPATHY + conventional analgesic treatments Other: Conventional analgesic treatments||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2015|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403168
|Centre Leon Berard|
|LYON Cedex 08, France, 69373|
|Principal Investigator:||Gisele CHVETZOFF, MD||Centre Leon Berard|