Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a mon...
Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.
Tracking Information
- NCT #
- NCT04547595
- Collaborators
- Not Provided
- Investigators
- Study Chair: Anna MOLTO, MD, PhD APHP
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