Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Not Applicable
Terminated
- Conditions
- Breast Cancer
- Registration Number
- NCT01403168
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Efficacy of the osteopathy treatment on pain 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Leon Berard
🇫🇷LYON Cedex 08, France
Centre Leon Berard🇫🇷LYON Cedex 08, France