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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04176341

38RC19.143

Details and patient eligibility

About

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 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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Intervention group

Other group

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.

Treatment:

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 group

Description:

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