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

NCT ID: NCT04176341

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2023-02-15

Brief Summary

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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

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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.

Conditions

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Chronic Pain Slackline Mindfulness Adapted Physical Activity Self-hypnosis Qi Gong

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type 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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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non pharmacological interventions

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Groupe Hospitalier Mutualiste de Grenoble

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline Maindet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU de GRENOBLE ALPES

Grenoble, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29623667 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 30179389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29669089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19836888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29793007 (View on PubMed)

Other Identifiers

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38RC19.143

Identifier Type: -

Identifier Source: org_study_id

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