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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Control group
    • chronic pain patient consulting in Lyon University Hospital who will receive usual care.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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.

Secondary Measures

  • Compare the effectiveness of the intervention versus usual care between M6-M3-M0
    • Time Frame: 3 and 6 months
    • 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.
  • Describe adherence of the intervention
    • Time Frame: 6 months
    • Number of participated workshops by patients
  • Describe side effects of the intervention
    • Time Frame: 6 months
    • Report eventuels side effects occuring during interventions
  • Compare changes in quality of life at 3 and 6 months compared to baseline.
    • Time Frame: 3 and 6 months
    • Evolution of the generic quality of life measured by the EQ5D-3L questionnaire at 3 and 6 months compared to baseline
  • 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.
    • Time Frame: 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.
  • 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.
    • Time Frame: 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.
  • Compare the evolution of the health care consumption of the subjects at 3 and 6 months compared to baseline.
    • Time Frame: 3 and 6 months
    • 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.
  • 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.
    • Time Frame: 3 and 6 months
    • 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.
  • 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
    • Time Frame: 6 months
    • 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.
  • Compare the evolution of the ability to cope with subjects at 3 and 6 months compared to baseline.
    • Time Frame: 3 and 6 months
    • Evolution of the Ways of Coping Checklist on the patient’s ability to cope at 3 and 6 months compared to baseline
  • Compare the evolution of the catastrophism of the subjects at 3 and 6 months compared to baseline.
    • Time Frame: 3 and 6 months
    • Evolution of the PCS-CF Pain Catastrophism Scale [0-52] at 3 and 6 Months compared to baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Grenoble
  • Collaborator
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caroline Maindet, MD, Principal Investigator, University Hospital, Grenoble
  • Overall Contact(s)
    • Caroline Maindet, MD, +33476765213, Cmaindetdominici@chu-grenoble.fr

References

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. Review.

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. 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. Review.

Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hróbjartsson 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. Review.

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