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

June 26, 2015 updated by: Centre Leon Berard

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LYON Cedex 08, France, 69373
        • Centre Leon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Gisèle CHVETZOFF, MD, Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSTEOPATHIE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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