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Completed

NCT Number: NCT04547595

Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cochin Hospital - Rheumatology department

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypnosis

Other

given by Expert in this method

Other names: Ericksonienne Method

Primary outcomes

  1. Pain assessed by Visual Analog Scale

    Time frame: One Day, at end of lavage procedure

    VAS range 0-10, 10 for most severe pain

Secondary outcomes

  1. Anxiety assessed by Visual Analog Scale

    Time frame: Day 1, before lavage procedure

    VAS range 0-10, 10 for most severe anxiety

  2. Anxiety assessed by Visual Analog Scale

    Time frame: Day 1, at end of lavage procedure

    VAS range 0-10, 10 for most severe anxiety

  3. Pain assessed by Visual Analog Scale

    Time frame: Day 1, before lavage procedure

    VAS range 0-10, 10 for most severe pain

  4. Pain assessed by Visual Analog Scale

    Time frame: Day 7, after lavage procedure

    VAS range 0-10, 10 for most severe pain -via phone call

  5. Gesture tolerability

    Time frame: Day 1, at end of lavage procedure

    4 points : Perfectly tolerable / tolerable / with difficulty / untolerable

  6. Analgesics consumption

    Time frame: Over 1 week after lavage procedure

    Quantification

  7. Operator Impact

    Time frame: Over 1 week after lavage procedure

    pain VAS by linear regression, adjusted by the 'operator' variable

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: HypnoArt

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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