Clinical trial NCT02621437: Impact of Osteopathy on Pain After Breast Cancer Surgery
Official title: Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: pain
quality of life
osteopathy
oncology
surgery
breast
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.

Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).

The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.

This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.


Eligibility criteria: Inclusion Criteria:

* Adult woman
* Surgery for a malignant breast tumor with sentinel lymph node technique
* Patient affiliated to a social security system
* Willing and able to provide written informed consent

Exclusion Criteria:

* Under-age women
* Pregnant woman
* Surgery for a malignant breast tumor with lymph node dissection
* Receiving adjuvant therapy during the study
* Receiving physiotherapy sessions (other than those made in immediate post-operative)
* Participating in the space "Au Fil de Soi": relaxing body massage and Energy Resonance by Cutaneous Stimulation (RESC)
* Person under guardianship or supervision
* Patient with impaired cognitive functions or lack of understanding of the French language
* Presenting a contraindication for osteopathy (major infectious and inflammatory conditions, trauma and other severe diseases)

Primary outcomes:
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at Day 9
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at day 20
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at day 26
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at Day 34
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at Day 40
measure: Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
timeFrame: at Day 48
Secondary outcomes:
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 9
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 20
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 26
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 34
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 40
measure: Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
timeFrame: at day 48
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 9
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 20
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 26
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 34
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 40
measure: Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
timeFrame: at Day 48
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de gynécologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Gil DUBERNARD, Pr
role: PRINCIPAL_INVESTIGATOR
References: