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

NCT04176341 | Completed

• 1 other identifier: 38RC19.143
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Compare the effectiveness of the intervention versus usual care between M6-M3-M0

  3 and 6 months

• Describe adherence of the intervention

  6 months

• Describe side effects of the intervention

  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 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

Study Arms (2)

Intervention group

OTHER

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

Control group

NO INTERVENTION

chronic pain patient consulting in Lyon University Hospital who will receive usual care.

Interventions

a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong OTHER

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.

Also known as: non pharmacological interventions

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Protected persons

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Hospices Civils de Lyon: collaborator
• Groupe Hospitalier Mutualiste de Grenoble: collaborator

Study Sites (1)

CHU de GRENOBLE ALPES

Grenoble, 38000, France

Location

Related Publications (5)

• 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.

  PMID: 29623667 BACKGROUND

• 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/

  PMID: 30179389 BACKGROUND

• 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.

  PMID: 29669089 BACKGROUND

• 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.

  PMID: 19836888 BACKGROUND

• 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.

  PMID: 29793007 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness; Hypnosis; Qigong

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Breathing Exercises; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Caroline Maindet, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 25, 2019
• Study Start: December 18, 2019
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: May 14, 2024

Record last verified: 2021-09

Locations

FR (1)