Knee Osteoarthritis
Conditions
Keywords
hypnosis intervention, analgesics, knee osteoarthritis, joint lavage
Brief summary
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
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.
Interventions
OTHERHypnosis
given by Expert in this method
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of knee osteoarthritis * indication for a lavage
Exclusion criteria
* People who have had both knees washed on the same day. * People who have already received a joint lavage. * Patients with psychotic disorders. * Refusal to participate. * People who do not understand and/or speak French or who are deaf.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessed by Visual Analog Scale | One Day, at end of lavage procedure | VAS range 0-10, 10 for most severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety assessed by Visual Analog Scale | Day 1, before lavage procedure | VAS range 0-10, 10 for most severe anxiety |
| Pain assessed by Visual Analog Scale | Day 1, before lavage procedure | VAS range 0-10, 10 for most severe pain |
| Gesture tolerability | Day 1, at end of lavage procedure | 4 points : Perfectly tolerable / tolerable / with difficulty / untolerable |
| Analgesics consumption | Over 1 week after lavage procedure | Quantification |
| Operator Impact | Over 1 week after lavage procedure | pain VAS by linear regression, adjusted by the 'operator' variable |
Countries
France
Contacts
STUDY_CHAIRAnna MOLTO, MD, PhD
APHP
Outcome results
None listed