A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis

NCT ID: NCT03644615

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2019-09-04

Brief Summary

Symptomatic osteoarthritis (OA) is the most common joint disease and the leading cause of disability in industrialized countries. Therapeutic approaches to prevent the development and progression of osteoarthritis are disappointing and very limited. New therapeutic alternatives seem essential to better manage his daily life. Non-drug approaches, including psycho-corporal approaches are increasingly used in the management of chronic pain.

Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.

Regarding rheumatological pathologies, a Mindfulness Program (MBSR) has shown its effectiveness in chronic pain; and in particular in osteo-articular localization, such as chronic low back pain. A recent study found a correlation between a pre-disposition to mindfulness and less pain and / or better quality of life in patients with knee osteoarthritis. However, to the knowledge of investigator, no study has evaluated the effectiveness of an intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip.

The goal of investigator is to evaluate, using a randomized, controlled study, the effect of a mindfulness program (according to the MBSR protocol) on pain, function, psychological state and quality of life patients with knee or hip osteoarthritis

Conditions

Osteoarthritis; Mindfulness; MBSR

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfluness and usual care

Group Type: EXPERIMENTAL

Mindfluness and usual care

Intervention Type: OTHER

Intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip. Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.

Usual Care

Group Type: OTHER

Usual care

Intervention Type: OTHER

No intervention on the patients

Interventions

Mindfluness and usual care

Intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip. Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.

Intervention Type: OTHER

Usual care

No intervention on the patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Osteoarthritis of the knee or hip (Kellgren and Lawrence X-ray stage ≥ 2)
• Mean pain VAS on at least one reference joint (knee or hip)> 40 mm during the last week
• Stable treatment with analgesics for at least a week

Exclusion Criteria

• Corticosteroids (oral or injectable) in the month prior to inclusion
• Intra-articular injection of hyaluronic acid in the last 3 months prior to inclusion
• Inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis, CCPD)
• Current depressive episode
• Psychotic disorders
• Usual practice of a relaxation method (mindfulness, yoga, sophrology ...)
• Major protected by law (guardianship, curatorship or under the safeguard of justice)
• Subject in a period of exclusion relative to another protocol or for which the annual amount maximum compensation of € 4500 has been reached.
• Subject participating in another research protocol
• Subject not affiliated to a social security
• Pregnant woman, parturient or nursing, patient unable to give her major consent protected, vulnerable persons (Articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
• Subject deprived of liberty by judicial or administrative decision

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rhumatology Department - CHU Montpellier

Montpellier, , France

Countries

France

References

Marais C, Song Y, Ferreira R, Aounti S, Duflos C, Baptista G, Pers YM. Evaluation of mindfulness based stress reduction in symptomatic knee or hip osteoarthritis patients: a pilot randomized controlled trial. BMC Rheumatol. 2022 May 30;6(1):46. doi: 10.1186/s41927-022-00277-9.

Reference Type: BACKGROUND

PMID: 35637515 (View on PubMed)

Related Links

https://rdcu.be/cODwx

open access

Other Identifiers

2018-A00243-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL17_0430

Identifier Type: -

Identifier Source: org_study_id