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Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

NCT ID: NCT04547595

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Keywords

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hypnosis intervention analgesics knee osteoarthritis joint lavage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CONTROL

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Hypnosis

Standard care + intervention

Group Type ACTIVE_COMPARATOR

Hypnosis

Intervention Type OTHER

given by Expert in this method

Interventions

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Hypnosis

given by Expert in this method

Intervention Type OTHER

Other Intervention Names

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Ericksonienne Method

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna MOLTO, MD, PhD

Role: STUDY_CHAIR

APHP

Locations

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Cochin Hospital - Rheumatology department

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Melissa CREHALET MONNIER, Nurse

Role: CONTACT

Phone: + 33 1 58 41 86 51

Email: [email protected]

Guillaume MASSON, MSc

Role: CONTACT

Phone: +33611208860

Email: [email protected]

Facility Contacts

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Melissa CREHALET MONNIER, Nurse

Role: primary

Other Identifiers

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2020-A02333-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200138

Identifier Type: -

Identifier Source: org_study_id