Clinical trial NCT04547595: Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
Official title: Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: hypnosis intervention
analgesics
knee osteoarthritis
joint lavage
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessed by Visual Analog Scale
timeFrame: One Day, at end of lavage procedure
Secondary outcomes:
measure: Anxiety assessed by Visual Analog Scale
timeFrame: Day 1, before lavage procedure
measure: Anxiety assessed by Visual Analog Scale
timeFrame: Day 1, at end of lavage procedure
measure: Pain assessed by Visual Analog Scale
timeFrame: Day 1, before lavage procedure
measure: Pain assessed by Visual Analog Scale
timeFrame: Day 7, after lavage procedure
measure: Gesture tolerability
timeFrame: Day 1, at end of lavage procedure
measure: Analgesics consumption
timeFrame: Over 1 week after lavage procedure
measure: Operator Impact
timeFrame: Over 1 week after lavage procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital - Rheumatology department
Study officials:
affiliation: APHP
name: Anna MOLTO, MD, PhD
role: STUDY_CHAIR
References: