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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of the osteopathy treatment on pain

Outcome Description:

Pain is assessed by means of visual analogic scale (from 0 to 10 points). A decrease of 2 points after 3 months is expected.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Gisele CHVETZOFF, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

OSTEOPATHIE

NCT ID:

NCT01403168

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Osteopathy
  • Breast cancer
  • Pain
  • Breast Neoplasms

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