Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intervention group (osteopathy)
Patients will have three sessions of osteopathy and 6 phone questionnaires.
干预措施: Osteopathy sessions (Other)
Intervention group (osteopathy)
Patients will have three sessions of osteopathy and 6 phone questionnaires.
干预措施: phone questionnaires (Other)
control group
Patients will have 6 phone questionnaires.
干预措施: phone questionnaires (Other)
结局指标
主要结局
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)