Feasibility and Clinical Impact Study of Non Pharmacological Interventions Targeting the Subject's Empowerment Among Slackline, Mindfulness, Adapted Physical Activity, Self-hypnosis, Qi Gong Versus Usual Care in Management of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment versus usual care in the management of chronic pain
研究概览
简要总结
This feasability study aims to compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong versus usual care in the management of chronic pain.
详细描述
Chronic pain management is complex. 27.2 to 43.5 % of general population suffers from it. Opoid crisis has shown the limit of the WHO 3 step analgesic ladder. Multidisciplinary pain management programs, shared decision making and non pharmacological interventions targeting subject's empowerment are needed. Among these non pharmacological interventions, patients are increasingly turning to traditional and complementary medicines. Evidence about their safety and efficacy is hard to build. Thus our study aims to assess the feasibility of a systematic proposal for non pharmacological interventions targeting the subject's empowerment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with stable chronic pain defined by the presence of pain for more than 3 months and without substantial change in management in the month prior to inclusion
- •Patient with a mean EVA maximum daily pain over 7 days greater than or equal to 4/10
- •Patient aged 18 and over
- •Informed and written consent signed by the patient (or his / her legal representative).
- •Person affiliated with social security or beneficiary of such a scheme
排除标准
- •Patient with a cluster headache
- •Patient followed for 7 years or more by a pain center
- •Patient treated with adjuvant or neo-adjuvant chemotherapy or radiotherapy for the primary tumor
- •Patient with a decompensated psychiatric condition
- •Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study; this impact is left to the investigator's discretion
- •Protected persons
研究组 & 干预措施
Intervention group
chronic pain patient consulting in Grenoble Alps University Hospital, and Hospital Mutualist Group who will one non pharmacological intervention between slackline, mindfulness, adapted physical activity, self-hypnosis, Qi Gong during 6 to 8 weeks.
干预措施: a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong (Other)
Control group
chronic pain patient consulting in Lyon University Hospital who will receive usual care.
结局指标
主要结局
Compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment versus usual care in the management of chronic pain
时间窗: 6 months
The success of the intervention will be defined as a reduction of 30% or more of the average daily Visual Analog Score \[0-10\] for pain collected the 7 days prior to the M6 visit, compared to baseline status before intervention.
次要结局
- Evaluate the evolution of the overall motivation of the subjects of the Intervention group at different times of the study: before, during, just after the intervention, and at 3 and 6 months.(3 and 6 months)
- Compare the evolution of the ability to cope with subjects at 3 and 6 months compared to baseline.(3 and 6 months)
- Compare the evolution of the catastrophism of the subjects at 3 and 6 months compared to baseline.(3 and 6 months)
- Describe adherence of the intervention(6 months)
- Compare the effectiveness of the intervention versus usual care between M6-M3-M0(3 and 6 months)
- Describe side effects of the intervention(6 months)
- Compare the evolution of the health care consumption of the subjects at 3 and 6 months compared to baseline.(3 and 6 months)
- Compare changes in quality of life at 3 and 6 months compared to baseline.(3 and 6 months)
- Evaluate the evolution of the detailed motivation of the subjects of the Intervention group at different times of the study: before, during, just after the intervention, and at 3 and 6 months.(3 and 6 months)
- Evaluate the success of the intervention (intervention group) or the conventional follow-up (control group) from the patient's point of view at 3 and 6 months compared to baseline.(3 and 6 months)
- Sub-group analysis for healthcare professionals : compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment versus usual care in the management of chronic pain(6 months)