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Completed

NCT Number: NCT04176341

Feasability and Clinical Impact Study of Non Pharmacological Interventions 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.

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Key information

Conditions

Chronic Pain Adapted Physical Activity Mindfulness Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Qi Gong Self-hypnosis Signs and Symptoms Slackline

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de GRENOBLE ALPES

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: non pharmacological interventions

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

    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 outcomes

  1. 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.

  2. Describe adherence of the intervention

    Time frame: 6 months

    Number of participated workshops by patients

  3. Describe side effects of the intervention

    Time frame: 6 months

    Report eventuels side effects occuring during interventions

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Groupe Hospitalier Mutualiste de Grenoble
  • Hospices Civils de Lyon

Registry information

Official study 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

Acronym: ELISAD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 25, 2019
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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