Clinical trial NCT04176341: Feasability and Clinical Impact Study of Non Pharmacological Interventions in Management of Chronic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Slackline
Mindfulness
Adapted Physical Activity
Self-hypnosis
Qi Gong
Keywords: non pharmacological interventions
chronic pain
slackline
mindfulness
adapted physical activity
self-hypnosis
Qi Gong
shared decision making
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: Groupe Hospitalier Mutualiste de Grenoble
First posted: 2019-11-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group : chronic pain patient consulting in Grenoble Alps University Hospital and Grenoble Hospital Mutualist Group who will one non pharmacological intervention between slackline, mindfulness, adapted physical activity, self-hypnosis, Qi Gong during 6 to 8 weeks.

Control group : chronic pain patient consulting in Lyon University Hospital who will receive usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Compare the effectiveness of the intervention versus usual care between M6-M3-M0
timeFrame: 3 and 6 months
measure: Describe adherence of the intervention
timeFrame: 6 months
measure: Describe side effects of the intervention
timeFrame: 6 months
measure: Compare changes in quality of life at 3 and 6 months compared to baseline.
timeFrame: 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
measure: Compare the evolution of the health care consumption of the subjects at 3 and 6 months compared to baseline.
timeFrame: 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
measure: 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
timeFrame: 6 months
measure: Compare the evolution of the ability to cope with subjects at 3 and 6 months compared to baseline.
timeFrame: 3 and 6 months
measure: Compare the evolution of the catastrophism of the subjects at 3 and 6 months compared to baseline.
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de GRENOBLE ALPES
Study officials:
affiliation: University Hospital, Grenoble
name: Caroline Maindet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shipton EA, Shipton EE, Shipton AJ. A Review of the Opioid Epidemic: What Do We Do About It? Pain Ther. 2018 Jun;7(1):23-36. doi: 10.1007/s40122-018-0096-7. Epub 2018 Apr 6.
citation: Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, Fu R, Brodt ED, Wasson N, Winter C, Ferguson AJR. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Jun. Report No.: 18-EHC013-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK519953/
citation: Devan H, Hale L, Hempel D, Saipe B, Perry MA. What Works and Does Not Work in a Self-Management Intervention for People With Chronic Pain? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2018 May 1;98(5):381-397. doi: 10.1093/ptj/pzy029.
citation: Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.
citation: Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hrobjartsson A. Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies. J Clin Epidemiol. 2018 Sep;101:87-106.e2. doi: 10.1016/j.jclinepi.2018.05.007. Epub 2018 May 21.