Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03644615
Other study ID # 7534
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2018
Est. completion date September 4, 2019

Study information

Verified date June 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 4, 2019
Est. primary completion date March 4, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Usual care
No intervention on the patients

Locations

Country Name City State
France Rhumatology Department - CHU Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & 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: 10.11 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) 3 months
Secondary 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) 6 months
Secondary 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. 3 months
Secondary 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. 6 months
Secondary 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.
3 months
Secondary 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.
6 months
Secondary 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. 3 months
Secondary 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. 6 months
Secondary 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 3 months
Secondary 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 6 months
See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Completed NCT02544620 - Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study

External Links