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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
154
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.
CHU de GRENOBLE ALPES
Grenoble, France
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
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.
Time frame: 6 months
Compare the effectiveness of the intervention versus usual care between M6-M3-M0
Average daily pain visual analogue scale collected the 7 days prior to the visit of M0, M3 and M6. We will perform a subgroup analysis per workshop if n ≥ 25 in this one.
Time frame: 3 and 6 months
Describe adherence of the intervention
Number of participated workshops by patients
Time frame: 6 months
Describe side effects of the intervention
Report eventuels side effects occuring during interventions
Time frame: 6 months
Compare changes in quality of life at 3 and 6 months compared to baseline.
Evolution of the generic quality of life measured by the EQ5D-3L questionnaire at 3 and 6 months compared to baseline
Time frame: 3 and 6 months
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.
Evaluate the evolution of the overall motivation (EMG-28 scale) at 3 and 6 months compared to baseline for the subjects of the Intervention group. To evaluate the motivation of the subjects of the intervention group with Likert scales (importance / confidence / disposition) before, during, just after the intervention, and at 3 and 6 months.
Time frame: 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.
Evaluate motivation of the subjects of the intervention group with Likert scales (importance / confidence / disposition) before, during, just after the intervention, and at 3 and 6 months.
Time frame: 3 and 6 months
Compare the evolution of the health care consumption of the subjects at 3 and 6 months compared to baseline.
Count drug consumption, herbal medicine, homeopathy, food supplements, use of care (medical consultations, hospitalization, use of complementary medicines (acupuncture, osteopathy, micro physiotherapy, chiropractic ...), professional absenteeis that occurs to patient during the study.
Time frame: 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.
Binary success / failure criterion chosen by the patient during the inclusion visit among 5 criteria previously defined by a focus group of chronic pain patients upstream of the study, at 3 and 6 months compared to baseline.
Time frame: 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
Sub-group analysis for healthcare professionals of the success of the intervention 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.
Time frame: 6 months
Compare the evolution of the ability to cope with subjects at 3 and 6 months compared to baseline.
Evolution of the Ways of Coping Checklist on the patient's ability to cope at 3 and 6 months compared to baseline
Time frame: 3 and 6 months
Compare the evolution of the catastrophism of the subjects at 3 and 6 months compared to baseline.
Evolution of the PCS-CF Pain Catastrophism Scale \[0-52\] at 3 and 6 Months compared to baseline
Time frame: 3 and 6 months
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