search
Back to results

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

Primary Purpose

Chronic Pain, Slackline, Mindfulness

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring non pharmacological interventions, chronic pain, slackline, mindfulness, adapted physical activity, self-hypnosis, Qi Gong, shared decision making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de GRENOBLE ALPESRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome 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
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 Outcome Measures

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.
Describe adherence of the intervention
Number of participated workshops by patients
Describe side effects of the intervention
Report eventuels side effects occuring during interventions
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
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.
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.
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.
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.
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.
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
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

Full Information

First Posted
November 15, 2019
Last Updated
March 19, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Hospices Civils de Lyon, Groupe Hospitalier Mutualiste de Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT04176341
Brief Title
Feasability and Clinical Impact Study of Non Pharmacological Interventions in Management of Chronic Pain
Acronym
ELISAD
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Hospices Civils de Lyon, Groupe Hospitalier Mutualiste de Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Other
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
chronic pain patient consulting in Lyon University Hospital who will receive usual care.
Intervention Type
Other
Intervention Name(s)
a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong
Other Intervention Name(s)
non pharmacological interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Compare the effectiveness of the intervention versus usual care between M6-M3-M0
Description
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.
Time Frame
3 and 6 months
Title
Describe adherence of the intervention
Description
Number of participated workshops by patients
Time Frame
6 months
Title
Describe side effects of the intervention
Description
Report eventuels side effects occuring during interventions
Time Frame
6 months
Title
Compare changes in quality of life at 3 and 6 months compared to baseline.
Description
Evolution of the generic quality of life measured by the EQ5D-3L questionnaire at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
Compare the evolution of the health care consumption of the subjects at 3 and 6 months compared to baseline.
Description
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.
Time Frame
3 and 6 months
Title
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.
Description
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.
Time Frame
3 and 6 months
Title
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
Description
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.
Time Frame
6 months
Title
Compare the evolution of the ability to cope with subjects at 3 and 6 months compared to baseline.
Description
Evolution of the Ways of Coping Checklist on the patient's ability to cope at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
Compare the evolution of the catastrophism of the subjects at 3 and 6 months compared to baseline.
Description
Evolution of the PCS-CF Pain Catastrophism Scale [0-52] at 3 and 6 Months compared to baseline
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Maindet, MD
Phone
+33476765213
Email
Cmaindetdominici@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gilliane Lalami
Phone
+33476766729
Email
GLalami@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Maindet, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de GRENOBLE ALPES
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
29623667
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.
Results Reference
background
PubMed Identifier
30179389
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/
Results Reference
background
PubMed Identifier
29669089
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.
Results Reference
background
PubMed Identifier
19836888
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.
Results Reference
background
PubMed Identifier
29793007
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs