Feasability and Clinical Impact Study of Non Pharmacological Interventions in Management of Chronic Pain (ELISAD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Mindfulness; Adapted Physical Activity; Slackline; Self-hypnosis; Qi Gong
• Intervention / Treatment: Other: a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong

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.

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Recruiting
    • CHU de Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong; 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.; Other Names: non pharmacological interventions
NO_INTERVENTION: Control group; chronic pain patient consulting in Lyon University Hospital who will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 and 6 months
Describe adherence of the intervention	Number of participated workshops by patients	6 months
Describe side effects of the intervention	Report eventuels side effects occuring during interventions	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	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.	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.	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.	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.	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.	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	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	3 and 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Hospices Civils de Lyon; Groupe Hospitalier Mutualiste de Grenoble

Publications and helpful links

General Publications

• 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.
• 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/
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2019
• Primary Completion (ANTICIPATED): September 15, 2021
• Study Completion (ANTICIPATED): July 15, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: chronic pain; mindfulness; shared decision making; adapted physical activity; self-hypnosis; Qi Gong; slackline; non pharmacological interventions
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 38RC19.143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No