Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Other: OSTEOPATHY + conventional analgesic treatments; Other: Conventional analgesic treatments

• 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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Primary Completion: 2014-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-06-29

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

Arm && Interventions

Group	Intervention	Description
osteopathy + conventional analgesic treatments	OSTEOPATHY + conventional analgesic treatments	-
conventional analgesic treatments	Conventional analgesic treatments	-

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.

Trial Locations

Locations (1)

Centre Leon Berard; 🇫🇷 LYON Cedex 08, France