Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention group (osteopathy)
Patients will have three sessions of osteopathy and 6 phone questionnaires.
Intervention: Osteopathy sessions (Other)
Intervention group (osteopathy)
Patients will have three sessions of osteopathy and 6 phone questionnaires.
Intervention: phone questionnaires (Other)
control group
Patients will have 6 phone questionnaires.
Intervention: phone questionnaires (Other)
Outcomes
Primary Outcomes
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at Day 48
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at Day 9
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at day 20
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at day 26
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at Day 34
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Time Frame: at Day 40
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Secondary Outcomes
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 48)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 48)
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 9)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 9)
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 20)
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 26)
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 34)
- Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.(at day 40)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 20)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 26)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 34)
- Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.(at Day 40)