Effects of Mindfulness-Based Stress Reduction on Knee Osteoarthritis

NCT03527849 | Completed

• 1 other identifier: 1180036
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis; Knee Pain

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  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.

  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.

Secondary Outcomes (6)

• Change in Emotion Regulation Questionnaire (ERQ)

  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.

• Change in 5 Facet Mindfulness Questionnaire (FFMQ)

  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.

• Change in Pain Catastrophizing Scale (PCS)

  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.

• Change in Plasma Cortisol Levels

  At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10)

• Change in Cytokine Plasma Levels

  At First Clinical Visit (Baseline Week 1) and at Second Clinical Visit (Post-Treatment Week 10)

Study Arms (3)

In-Person MBSR Course

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction

Online MBSR Course

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction

In-Person HEP

ACTIVE COMPARATOR

Behavioral: Health Enhancement Program

Interventions

Mindfulness-Based Stress Reduction BEHAVIORAL

The intervention will be an MBSR course.

Also known as: Mindfulness

In-Person MBSR Course; Online MBSR Course

Health Enhancement Program BEHAVIORAL

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.

Also known as: HEP

In-Person HEP

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center

Davis, California, 95817, United States

Location

Related Publications (15)

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  BACKGROUND

• Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Juni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086.

  PMID: 21224324 RESULT

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  PMID: 10369853 RESULT

• Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing. 2012 Sep;41(5):646-52. doi: 10.1093/ageing/afs072. Epub 2012 Jun 27.

  PMID: 22743149 RESULT

• Chappell AS, Desaiah D, Liu-Seifert H, Zhang S, Skljarevski V, Belenkov Y, Brown JP. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract. 2011 Jan-Feb;11(1):33-41. doi: 10.1111/j.1533-2500.2010.00401.x.

  PMID: 20602715 RESULT

• Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, Hunter DJ. Psychological factors and their relation to osteoarthritis pain. Osteoarthritis Cartilage. 2010 Jul;18(7):883-7. doi: 10.1016/j.joca.2009.11.016. Epub 2010 Mar 24.

  PMID: 20346403 RESULT

• Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

  PMID: 20350028 RESULT

• Hilton L, Hempel S, Ewing BA, Apaydin E, Xenakis L, Newberry S, Colaiaco B, Maher AR, Shanman RM, Sorbero ME, Maglione MA. Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis. Ann Behav Med. 2017 Apr;51(2):199-213. doi: 10.1007/s12160-016-9844-2.

  PMID: 27658913 RESULT

• O'Leary K, O'Neill S, Dockray S. A systematic review of the effects of mindfulness interventions on cortisol. J Health Psychol. 2016 Sep;21(9):2108-21. doi: 10.1177/1359105315569095. Epub 2015 Feb 10.

  PMID: 25673371 RESULT

• Rosenkranz MA, Lutz A, Perlman DM, Bachhuber DR, Schuyler BS, MacCoon DG, Davidson RJ. Reduced stress and inflammatory responsiveness in experienced meditators compared to a matched healthy control group. Psychoneuroendocrinology. 2016 Jun;68:117-25. doi: 10.1016/j.psyneuen.2016.02.013. Epub 2016 Feb 20.

  PMID: 26970711 RESULT

• Yadav RK, Magan D, Mehta N, Sharma R, Mahapatra SC. Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results. J Altern Complement Med. 2012 Jul;18(7):662-7. doi: 10.1089/acm.2011.0265.

  PMID: 22830969 RESULT

• MacCoon DG, Imel ZE, Rosenkranz MA, Sheftel JG, Weng HY, Sullivan JC, Bonus KA, Stoney CM, Salomons TV, Davidson RJ, Lutz A. The validation of an active control intervention for Mindfulness Based Stress Reduction (MBSR). Behav Res Ther. 2012 Jan;50(1):3-12. doi: 10.1016/j.brat.2011.10.011. Epub 2011 Nov 11.

  PMID: 22137364 RESULT

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 RESULT

• Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

  PMID: 12916575 RESULT

• Lange T, Vansteelandt S, Bekaert M. A simple unified approach for estimating natural direct and indirect effects. Am J Epidemiol. 2012 Aug 1;176(3):190-5. doi: 10.1093/aje/kwr525. Epub 2012 Jul 10.

  PMID: 22781427 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Mindfulness-Based Stress Reduction; Mindfulness

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Barton L. Wise

  UC Davis School of Medicine

  PRINCIPAL INVESTIGATOR

• Philippe Goldin

  UC Davis Betty Irene School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 17, 2018
• Study Start: January 30, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available 6 months after study completion.
• Access Criteria: Data access requests will be reviewed by Principle Investigators.

Locations

US (1)