Clinical trial NCT01403168: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Official title: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Osteopathy
Breast cancer
Pain
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Efficacy of the osteopathy treatment on pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: LYON Cedex 08
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Leon Berard
name: Gisele CHVETZOFF, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13. No abstract available.
citation: Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.