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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Osteoarthritis
MBSR
Mindfulness

Treatments

Other: Mindfluness and usual care
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT03644615
2018-A00243-52 (Registry Identifier)
RECHMPL17_0430

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Mindfluness and usual care
Experimental group
Treatment:
Other: Mindfluness and usual care
Usual Care
Other group
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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