Clinical trial NCT03644615: A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
Official title: A Randomized Controlled Trial of a Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Mindfulness
MBSR
Keywords: Osteoarthritis
Mindfulness
MBSR
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score.
timeFrame: 6 months
Secondary outcomes:
measure: Changes in pain scores (VAS/100) between initiation visit and 3 months
timeFrame: 3 months
measure: Changes in pain scores (VAS/100) between initiation visit and 6 months
timeFrame: 6 months
measure: Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 3 months
timeFrame: 3 months
measure: Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 6 months
timeFrame: 6 months
measure: Changes in OARSI-OMERACT response criteria between initiation visit and 3 months
timeFrame: 3 months
measure: Changes in OARSI-OMERACT response criteria between initiation visit and 6 months
timeFrame: 6 months
measure: Changes in SF-36 score between initiation visit and 3 months
timeFrame: 3 months
measure: Changes in SF-36 score between initiation visit and 6 months
timeFrame: 6 months
measure: Changes in HAD score between initiation and 3 months
timeFrame: 3 months
measure: Changes in HAD score between initiation and 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Rhumatology Department - CHU Montpellier
Study officials:
References:
citation: 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.