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Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis (MBSR on KOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527849
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The purpose of this study is to see if stress reduction can lead to less pain due to knee osteoarthritis. To do this the investigators will compare two types of stress reduction modalities, Mindfulness-Based Stressed Reduction (MBSR) and a Health Enhancement Program (HEP). Both include stress reduction techniques, but MBSR has a mindfulness component that includes meditation. MBSR will be provided either in-person or online and HEP will be in-person. The assignment to the stress reduction program will be determined by the Principal Investigator. In order to assess for stress reduction and pain reduction the investigators will use validated measuring tools before, during, and after the course instructions.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Mindfulness-Based Stress Reduction Behavioral: Health Enhancement Program Not Applicable

Detailed Description:

The current study is aiming to compare two stress reduction programs in order to see if stress reduction may lead to less pain due to knee osteoarthritis (OA). There are two stress reduction programs being compared, Mindfulness-Based Stress Reduction (MBSR) and a Health Enhancement Program (HEP). MBSR is a secular program that trains mindfulness meditation for stress reduction and to increase emotional regulation skills. It is defined as "paying attention in a particular way, on purpose, in the present moment, and non-judgmentally." Mindfulness refers to a set of meditation practices that develop a wide array of cognitive skills which include: attention regulation, response inhibition, and emotion regulation. HEP is an educational course intended to teach participants about their disease, factors influencing disease progression, nutrition, physical activity including walking and stretching, and functional movement. Key difference between these two is MBSR includes the mindfulness component, and MBSR will be taught either in-person or online. HEP will only consist of an in-person course.

The online MBSR course will be offered through: http://www.breathworks-mindfulness.org.uk/mindfulness-for-health. The investigators propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient.

The duration of an individual subject's participation in the study will be at least 10 weeks starting from the screening visit all the way to the follow-up visit.

The in-person MBSR course consists of 8 weekly classes plus one all-day class between Weeks 6 and 7, and is sequential. Depending on when a participant is consented, they may have to wait until a new 8-week course is available in order to begin. The HEP course also consists of 8 weekly classes and will start when a group of 7-10 participants have been assigned to the HEP intervention. The online MBSR course is designed to last 8 weeks and can be started at any time.

Since initiation of the in-person MBSR or HEP courses will depend upon when subjects are enrolled, it is not possible to provide the maximum length of time for a subject's participation. However long the subject's participation, they are only expected to complete 2 in-clinic visits and 8 weeks of class (plus 1 all-day class for MBSR).

Weekly classes are 2.5 hours with the one-day retreat lasting from 10am to 5pm on a weekend day. The online MBSR course is roughly 20 minutes per day for 6-7 days of the week for 8 weeks.

HEP and MBSR are structurally equivalent, both using a group format that meets once a week for 2.5 hours for 8 weeks, plus home participation, but the in-person MBSR includes an "all day" component after week 6. The content of the HEP intervention meets the following criteria: (1) class activities match MBSR activities as closely as possible, (2) activities represent valid, active, therapeutic ingredients in their own right, and (3) these ingredients do not include mindfulness.

All participants will be assigned into one of the three courses by the Principal Investigator. Prior to the initial class of the participants' respective course, blood will be collected, and within two weeks after the final class, participants will return to collect the second set of blood samples. These collections prior and after treatment will be at the clinic, visits to the clinic may last from 1 to 2 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The study will be structured as a parallel-group controlled trial. The Principal Investigator will assign participants into the three groups. This will allow for equalization of distribution of participants across the three groups. It will not be possible to blind the participants to which arm of the trial they are participating in, as the content or lack thereof of their activities will be obvious to them. For results analysis, collaborators at the UCD West Coast Metabolomics Center will be blinded to the treatment of the respective samples, thus eliminating potential bias during analysis.
Primary Purpose: Basic Science
Official Title: The Effect of Mindfulness-Based Stress Reduction on Pain and Function in Persons With Knee Osteoarthritis
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: In-Person MBSR Course Behavioral: Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
Other Name: Mindfulness

Experimental: Online MBSR Course Behavioral: Mindfulness-Based Stress Reduction
The intervention will be an MBSR course.
Other Name: Mindfulness

Active Comparator: In-Person HEP Behavioral: Health Enhancement Program
Propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient. HEP and MBSR are structurally equivalent in that they share the same amount of in- and out-of class work time. The content of the HEP intervention meet the following criteria: (1) class activities match MBSR activities as closely as possible, (2) activities represent valid, active, therapeutic ingredients in their own right, and (3) these ingredients do not include mindfulness.
Other Name: HEP




Primary Outcome Measures :
  1. Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) [ Time Frame: At First Clinical Visit (Baseline Week 1), During Treatment (Once per week for 8 Weeks), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]
    A joint specific questionnaire used to measure the condition of patients with knee osteoarthritis, pain, stiffness, and physical functioning of the inflicted joints. Each question is answered by selecting a box from a scale of 0-10 (0=No Pain, 10=Extreme Pain). The investigators plan on collecting a baseline measurement prior to the treatment, weekly measurements through the treatment (1 per week for 8 weeks), and another after the treatment is completed to track changes.


Secondary Outcome Measures :
  1. Change in Emotion Regulation Questionnaire (ERQ) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-TreatmentWeek 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]

    A self-reported questionnaire that identifies the habitual use of two emotional regulation strategies, between cognitive reappraisal and expressive suppression.

    Answered in a scale ranging from 1-7 (1=strongly disagree, 4=neutral, 7=strongly agree). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.


  2. Change in 5 Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]
    A self-reported questionnaire intended to measure the five factors to conceptually be involved with mindfulness. It is answered using a 1-5 scale (1=never or very rarely true, 2=rarely true, 3=sometimes true, 4=often true, 5=very often or always true). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.

  3. Change in Pain Catastrophizing Scale (PCS) [ Time Frame: At First Clinical Visit (Baseline Week 1), Mid-Treatment (Week 5), at Second Clinical Visit (Post-Treatment Week 10), this will be done through the participant's duration in the study on average lasting 10 weeks. ]

    A self-reported questionnaire used to quantify an individual's pain experience through a series of questions asking about the individual's feelings and thoughts about when they are in pain.

    Answered in a scale of 0-4 (0=not at all, 1=to a slight degree, 2=to a moderate degree, 3=to a great degree, 4=all the time). Answered prior to receiving treatment, half-way through treatment completion, and post-treatment.


  4. Change in Plasma Cortisol Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]
    Cortisol is a hormone the human body releases in times of stress. Because the investigators are aiming to reduce stress the investigative team will be collecting blood (4mL RED-top Vacutainer tube) prior to beginning treatment (respective stress reduction course) and after the course is completed to assess if there were changes in cortisol levels. Cortisol levels will be obtained in micrograms per deciliter (ug/dL).

  5. Change in Cytokine Plasma Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]
    Cytokines are markers secreted by cells that help direct cell function during an immune response. The investigators will collect blood and process serum for analysis to measure and track changes in cytokine levels responsible for inflammation. The blood will be collected at the first clinical visit and the second clinical visit. The measurements will be interpreted in picograms per milliliter (pg/mL).

  6. Change in Oxylipin Plasma Levels [ Time Frame: At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10) ]
    Oxylipin inflammation markers will be measured from plasma processed from collected blood at the first and second clinical visits. There are usually 84 markers and are positively detected and quantified even in healthy individuals using 150uL of plasma. The investigative team expects there to be higher concentrations of these markers in elderly subjects with OA pain, furthermore, the investigators expect differences in concentrations of these markers for the different treatments. These values will be addressed in nanomolar (nM).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive "Frequent Knee Pain" question
  • Radiographically confirmed knee OA (Kellgren/Lawrence ≥ 2)

Exclusion Criteria:

  • Scheduled to have knee replacement surgery within 6 months from enrollment
  • Rheumatoid arthritis or another inflammatory arthritis
  • Known avascular necrosis (death of bone due to lack of blood supply)
  • Failure to comply with run-in procedures: poor attendance or non-compliant with completing the activity
  • Major psychiatric illness, cognitive impairment or alcohol/substance abuse
  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527849


Locations
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United States, California
University of California, Davis Medical Center
Davis, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Barton L. Wise UC Davis School of Medicine
Principal Investigator: Philippe Goldin UC Davis Betty Irene School of Nursing
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Publications of Results:

Other Publications:
Kabat-Zinn J, University of Massachusetts Medical Center/Worcester. Stress Reduction Clinic. Full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York, N.Y.:Delacorte Press; 1990.

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03527849    
Other Study ID Numbers: 1180036
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan on making unidentifiable participant data for all primary and secondary outcome measures available. No information linking the data to the individual participant will be released, but measurements, averages, and statistical analysis will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available 6 months after study completion.
Access Criteria: Data access requests will be reviewed by Principle Investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Osteoarthritis
Knee Osteoarthritis
Knee Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases