Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

Phase 3

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: Hypnosis

• Registration Number: NCT04547595
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Study Start: 2021-10-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis	Hypnosis	Standard care + intervention

Primary Outcome Measures

Name	Time	Method
Pain assessed by Visual Analog Scale	One Day, at end of lavage procedure	VAS range 0-10, 10 for most severe pain

Secondary Outcome Measures

Name	Time	Method
Operator Impact	Over 1 week after lavage procedure	pain VAS by linear regression, adjusted by the 'operator' variable
Anxiety assessed by Visual Analog Scale	Day 1, at end of lavage procedure	VAS range 0-10, 10 for most severe anxiety
Pain assessed by Visual Analog Scale	Day 7, after lavage procedure	VAS range 0-10, 10 for most severe pain -via phone call
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

Trial Locations

Locations (1)

Cochin Hospital - Rheumatology department; 🇫🇷 Paris, France