Hypnosis Intervention for the Management of Pain Perception During Joint Lavage (HypnoArt)

Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Hypnosis

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guillaume MASSON, MSc; Phone Number: +33 1 58 41 34 78; Email: guillaume.masson@aphp.fr
• Study Contact Backup: Name: Melissa CREHALET MONNIER, Nurse; Phone Number: + 33 1 58 41 86 51; Email: melissa.crealet-monnier@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cochin Hospital - Rheumatology department
    • Contact: Melissa CREHALET MONNIER, Nurse; Phone Number: +33 1 58 41 86 51; Email: melissa.crehalet-monnier@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of knee osteoarthritis
• indication for a lavage

Exclusion Criteria:

• previous knee lavage
• psychotic disorders
• current use of psychotropic drugs
• patient refusal
• who do not understand and/or speak french and hearing impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL; Standard care
Active Comparator: Hypnosis; Standard care + intervention	Other: Hypnosis; given by Expert in this method; Other Names: Ericksonienne Method

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety assessed by Visual Analog Scale	VAS range 0-10, 10 for most severe anxiety	Day 1, before lavage procedure
Anxiety assessed by Visual Analog Scale	VAS range 0-10, 10 for most severe anxiety	Day 1, at end of lavage procedure
Pain assessed by Visual Analog Scale	VAS range 0-10, 10 for most severe pain	Day 1, before lavage procedure
Pain assessed by Visual Analog Scale	VAS range 0-10, 10 for most severe pain -via phone call	Day 7, after lavage procedure
Gesture tolerability	4 points : Perfectly tolerable / tolerable / with difficulty / untolerable	Day 1, at end of lavage procedure
Analgesics consumption	Quantification	Over 1 week after lavage procedure
Operator Impact	pain VAS by linear regression, adjusted by the 'operator' variable	Over 1 week after lavage procedure

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Anna MOLTO, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: knee osteoarthritis; analgesics; hypnosis intervention; joint lavage
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: APHP200138; 2020-A02333-36 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No