Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

Study Overview
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Brief Summary
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The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis

Detailed Description
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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.

Official Title
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Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of knee osteoarthritis indication for a lavage Exclusion Criteria: previous knee lavage psychotic disorders current use of psychotropic drugs patient refusal who do not understand and/or speak french and hearing impaired

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>Standard care | |
| Active Comparator: Hypnosis<br>Standard care + intervention | Other: Hypnosis<br>* given by Expert in this method<br>* Other names: Ericksonienne Method;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain | One Day, at end of lavage procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe anxiety | Day 1, before lavage procedure | 
| Anxiety assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe anxiety | Day 1, at end of lavage procedure | 
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain | Day 1, before lavage procedure | 
| Pain assessed by Visual Analog Scale | VAS range 0-10, 10 for most severe pain -via phone call | Day 7, after lavage procedure | 
| Gesture tolerability | 4 points : Perfectly tolerable / tolerable / with difficulty / untolerable | Day 1, at end of lavage procedure | 
| Analgesics consumption | Quantification | Over 1 week after lavage procedure | 
| Operator Impact | pain VAS by linear regression, adjusted by the 'operator' variable | Over 1 week after lavage procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypnosis intervention, analgesics, knee osteoarthritis, joint lavage