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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
given by Expert in this method
Cochin Hospital - Rheumatology department
Paris, France
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain
Time frame: One Day, at end of lavage procedure
Anxiety assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe anxiety
Time frame: Day 1, before lavage procedure
Anxiety assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe anxiety
Time frame: Day 1, at end of lavage procedure
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain
Time frame: Day 1, before lavage procedure
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain -via phone call
Time frame: Day 7, after lavage procedure
Gesture tolerability
4 points : Perfectly tolerable / tolerable / with difficulty / untolerable
Time frame: Day 1, at end of lavage procedure
Analgesics consumption
Quantification
Time frame: Over 1 week after lavage procedure
Operator Impact
pain VAS by linear regression, adjusted by the 'operator' variable
Time frame: Over 1 week after lavage procedure
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