OsteoarthritisMINDFULNESS_OANCT03644615
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
A study of Osteoarthritis and Mindfulness, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Osteoarthritis, Mindfulness, MBSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2018to 4 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ...)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
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.
Read more
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
- Being tested
- Mindfluness and usual care, Usual care
- Keywords
- Osteoarthritis, Mindfulness, MBSR
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfluness and usual careOther
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 careOther
No intervention on the patients
| Study group | Role | What they receive |
|---|---|---|
| Mindfluness and usual care | Experimental | Not described Receives: Other: Mindfluness and usual care |
| Usual Care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
Changes in pain scores (VAS/100) between initiation visit and 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)
Measured: 3 months
Changes in pain scores (VAS/100) between initiation visit and 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)
Measured: 6 months
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 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.
Measured: 3 months
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 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.
Measured: 6 months
Changes in OARSI-OMERACT response criteria between initiation visit and 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.
Measured: 3 months
Changes in OARSI-OMERACT response criteria between initiation visit and 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.
Measured: 6 months
Changes in SF-36 score between initiation visit and 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.
Measured: 3 months
Changes in SF-36 score between initiation visit and 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.
Measured: 6 months
Changes in HAD score between initiation and 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
Measured: 3 months
Changes in HAD score between initiation and 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start5 Sep 2018
- Primary completion4 Mar 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644615
- Sponsor's protocol ID
- RECHMPL17_0430
- Other IDs
- 2018-A00243-52
- Acronym
- MINDFULNESS_OA
- Status last verified
- Jun 2022
- First submitted
- 21 Aug 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35637515
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03644615
- Acronym / sponsor ID
- MINDFULNESS_OA / RECHMPL17_0430
- Conditions
- Osteoarthritis, Mindfulness, MBSR
- Keywords
- Osteoarthritis, Mindfulness, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfluness and usual care | Experimental | Other: Mindfluness and usual care |
| Usual Care | Other | Other: Usual care |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfluness and usual careIntervention 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 | Mindfluness and usual care |
| Usual careNo intervention on the patients | Other | Usual Care |
Primary outcome
Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score.
Time frame: 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.
10 secondary outcomes
Changes in pain scores (VAS/100) between initiation visit and 3 months
Time frame: 3 months
Changes in pain scores (VAS/100) between initiation visit and 6 months
Time frame: 6 months
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 3 months
Time frame: 3 months
Changes in WOMAC questionnaire (total, pain, function and stiffness) between initiation visit and 6 months
Time frame: 6 months
Changes in OARSI-OMERACT response criteria between initiation visit and 3 months
Time frame: 3 months
Changes in OARSI-OMERACT response criteria between initiation visit and 6 months
Time frame: 6 months
Changes in SF-36 score between initiation visit and 3 months
Time frame: 3 months
Changes in SF-36 score between initiation visit and 6 months
Time frame: 6 months
Changes in HAD score between initiation and 3 months
Time frame: 3 months
Changes in HAD score between initiation and 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Results publication: PubMed 35637515Marais 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.
- open accessLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Osteoarthritis and Mindfulness, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of a mindfulness program as a treatment for hip or knee osteoarthritis on the WOMAC pain score. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.