Cochin Hospital - Rheumatology department
Paris, 75014, France
NCT Number: NCT04547595
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
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
given by Expert in this method
Other names: Ericksonienne Method
Time frame: One Day, at end of lavage procedure
VAS range 0-10, 10 for most severe pain
Time frame: Day 1, before lavage procedure
VAS range 0-10, 10 for most severe anxiety
Time frame: Day 1, at end of lavage procedure
VAS range 0-10, 10 for most severe anxiety
Time frame: Day 1, before lavage procedure
VAS range 0-10, 10 for most severe pain
Time frame: Day 7, after lavage procedure
VAS range 0-10, 10 for most severe pain -via phone call
Time frame: Day 1, at end of lavage procedure
4 points : Perfectly tolerable / tolerable / with difficulty / untolerable
Time frame: Over 1 week after lavage procedure
Quantification
Time frame: Over 1 week after lavage procedure
pain VAS by linear regression, adjusted by the 'operator' variable
Assistance Publique - Hôpitaux de Paris
Other
Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis
Acronym: HypnoArt
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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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