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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03644615

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Mindfulness MBSR	Other: Mindfluness and usual care Other: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Randomized Controlled Trial of a Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis

Actual Study Start Date :

Sep 5, 2018

Actual Primary Completion Date :

Mar 4, 2019

Actual Study Completion Date :

Sep 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfluness and usual care	Other: 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.
Other: Usual Care	Other: Usual care No intervention on the patients

Arm

Intervention/Treatment

Experimental: Mindfluness and usual care

Other: 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.

Other: Usual Care

Other: Usual care

No intervention on the patients

Outcome Measures

Primary Outcome Measures

Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score. [6 months]
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.

Secondary Outcome Measures

Changes in pain scores (VAS/100) between initiation visit and 3 months [3 months]
EVA pain (visual analogue scale over 100 mm): one-dimensional measurement of the intensity of pain. EVA pain is a continuous scale consisting of a horizontal line from 0 (no pain) to 100 mm (maximum pain)
Changes in pain scores (VAS/100) between initiation visit and 6 months [6 months]
EVA pain (visual analogue scale over 100 mm): one-dimensional measurement of the intensity of pain. EVA pain is a continuous scale consisting of a horizontal line from 0 (no pain) to 100 mm (maximum pain)
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 3 months [3 months]
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.
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 6 months [6 months]
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.
Changes in OARSI-OMERACT response criteria between initiation visit and 3 months [3 months]
The responder rate is defined by an improvement of 20%, with an absolute variation ≥ 10mm, on 2 of the following 3 measures: WOMAC pain, WOMAC function and / or overall assessment of disease activity by the patient. The overall evaluation of the patient's disease activity is performed on a 100 mm horizontal visual analogue scale (0 = inactive disease, 100 = highly active disease). It is used for the global assessment of the activity of the disease by the patient.
Changes in OARSI-OMERACT response criteria between initiation visit and 6 months [6 months]
The responder rate is defined by an improvement of 20%, with an absolute variation ≥ 10mm, on 2 of the following 3 measures: WOMAC pain, WOMAC function and / or overall assessment of disease activity by the patient. The overall evaluation of the patient's disease activity is performed on a 100 mm horizontal visual analogue scale (0 = inactive disease, 100 = highly active disease). It is used for the global assessment of the activity of the disease by the patient.
Changes in SF-36 score between initiation visit and 3 months [3 months]
The SF-36 includes 36 items divided into 8 dimensions (physical functioning, limitations of functions related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, limitations of functions related to mental health, physical health) to which were added 4 items examining the cognitive functioning, from the "Medical Outcomes Study". This questionnaire was supplemented by questions aimed at clarifying the socio-demographic profile of the participants as well as the use of care services.
Changes in SF-36 score between initiation visit and 6 months [6 months]
The SF-36 includes 36 items divided into 8 dimensions (physical functioning, limitations of functions related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, limitations of functions related to mental health, physical health) to which were added 4 items examining the cognitive functioning, from the "Medical Outcomes Study". This questionnaire was supplemented by questions aimed at clarifying the socio-demographic profile of the participants as well as the use of care services.
Changes in HAD score between initiation and 3 months [3 months]
The Hospital Anxiety and Depression (HAD) questionnaire assesses the psychological impact of the patient. It consists of 14 questions with 4 possible answers. This score makes it possible to differentiate a level of anxiety and a level of depression according to the answers. Each sub-scale varies from 0 to 21
Changes in HAD score between initiation and 6 months [6 months]
The Hospital Anxiety and Depression (HAD) questionnaire assesses the psychological impact of the patient. It consists of 14 questions with 4 possible answers. This score makes it possible to differentiate a level of anxiety and a level of depression according to the answers. Each sub-scale varies from 0 to 21

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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