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

NCT03644615 | Completed

• 2 other identifiers: RECHMPL17_04302018-A00243-52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Osteoarthritis; Mindfulness; MBSR

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score.

  Improvement in WOMAC pain before and after the program in the MBSR group compared to control group. The WOMAC is a validated index in the assessment of lower extremity osteoarthritis, by the system of rating the answers to questions by a visual analogue scale from 0 to 100 mm. It is possible to calculate the scores in each domain (pain, stiffness and function) or for the whole WOMAC. This is a self-administered questionnaire completed by the patient.

  6 months

Secondary Outcomes (10)

• Changes in pain scores (VAS/100) between initiation visit and 3 months

  3 months

• Changes in pain scores (VAS/100) between initiation visit and 6 months

  6 months

• Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 3 months

  3 months

• Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 6 months

  6 months

• Changes in OARSI-OMERACT response criteria between initiation visit and 3 months

  3 months

Study Arms (2)

Mindfluness and usual care

EXPERIMENTAL

Other: Mindfluness and usual care

Usual Care

OTHER

Other: Usual care

Interventions

Mindfluness and usual care 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.

Mindfluness and usual care

Usual care OTHER

No intervention on the patients

Usual Care

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Rhumatology Department - CHU Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 35637515 BACKGROUND

Related Links

• open access

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: September 5, 2018
• Primary Completion: March 4, 2019
• Study Completion: September 4, 2019
• Last Updated: September 30, 2025

Record last verified: 2022-06

Locations

FR (1)