Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

Knee Osteoarthritis Clinical Trial

— HypnoArt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547595
• Other study ID #: APHP200138
• Secondary ID: 2020-A02333-36
• Status: Recruiting
• Phase: Phase 3
• Start date: October 6, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Melissa CREHALET MONNIER, Nurse
• Phone: + 33 1 58 41 86 51
• Email: melissa.crealet-monnier[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Hypnosis
given by Expert in this method

Locations

Country	Name	City	State
France	Cochin Hospital - Rheumatology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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