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

This study has been terminated.
(Recruitment difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403168
First Posted: July 27, 2011
Last Update Posted: June 29, 2015
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.
Information provided by (Responsible Party):
Centre Leon Berard
  Purpose

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 Intervention
Breast Cancer Other: OSTEOPATHY + conventional analgesic treatments Other: Conventional analgesic treatments

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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.


Enrollment: 28
Study Start Date: April 2011
Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Centre Leon Berard
LYON Cedex 08, France, 69373
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Gisele CHVETZOFF, MD Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01403168     History of Changes
Other Study ID Numbers: OSTEOPATHIE
First Submitted: July 21, 2011
First Posted: July 27, 2011
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Centre Leon Berard:
Osteopathy
Breast cancer
Pain

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs