Positive Minds, Strong Joints for Knee Osteoarthritis

(PMSJ Trial)

Overseen By Deepak Kumar, PhD,PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Joint replacement, Systemic inflammatory arthritis, Neurologic conditions, High risk mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does exclude those who have received certain treatments like knee injections or physical therapy recently.

What data supports the effectiveness of the treatment Positive Minds, Strong Joints for Knee Osteoarthritis?

Research suggests that building positive psychological skills, like gratitude, can help reduce pain and improve functioning in people with knee osteoarthritis. This approach is part of a broader effort to explore non-drug treatments that focus on mental and emotional well-being to manage osteoarthritis symptoms. ^{1 2 3 4 5}

Is the Positive Minds, Strong Joints treatment safe for humans?

The research articles provided do not contain specific safety data for the Positive Minds, Strong Joints treatment or similar interventions. ^{3 4 6 7 8}

How is the Positive Minds, Strong Joints treatment different from other treatments for knee osteoarthritis?

The Positive Minds, Strong Joints treatment is unique because it focuses on building positive psychological skills, like gratitude, to reduce symptoms and improve well-being, rather than just addressing physical symptoms. This psychosocial approach is less explored in osteoarthritis treatment compared to traditional physical therapies or medications. ^{3 9 10 11 12}

What is the purpose of this trial?

The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).

Eligibility Criteria

This trial is for Black adults over 50 with knee osteoarthritis, living in specific Boston neighborhoods, and receiving care at BMC or a CHC. Participants must have moderate to severe knee pain, a BMI ≤ 40 kg/m2, and show signs of depression or anxiety. They need to be available for the study duration and intervention sessions, and speak English well enough to understand the procedures.

Inclusion Criteria

I live in Dorchester, Roxbury, Hyde Park, or Mattapan in Boston.

I can speak and understand English well enough to follow study instructions.

I identify as Black or African American.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-hour individual session of psychoeducation, mindfulness, and cognitive behavior therapy skills for 10 weeks via a HIPAA-protected zoom video-call or over the telephone. They also receive a community-based group exercise and pain education program once a week for 10 weeks.

10 weeks

10 visits (virtual), 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys conducted at multiple time points.

12 weeks

3 visits (virtual)

Treatment Details

Interventions

• Positive Minds, Strong Joints

Trial Overview The 'Positive Minds Strong Joints' program combines physical and mental health strategies specifically designed for Black adults with knee osteoarthritis. The study tests how feasible this approach is by monitoring participants' adherence and response to the intervention.

Participant Groups

Group I: Positive Minds Strong Joints Experimental Treatment 1 Intervention

Participants will receive an individual mental health intervention through a zoom video-call once a week for 10 weeks and a community-based group exercise intervention once a week for 10 weeks.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Rheumatology Research Foundation

Collaborator

Trials

14

Recruited

8,200+

Findings from Research

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

Mind-body exercise programs, such as Hatha Yoga and Tai Chi, have been shown to effectively improve pain relief and physical function in patients with knee osteoarthritis, based on a systematic review of high-quality studies.

Hatha Yoga and Tai Chi Qigong received high grades for their effectiveness, with significant improvements noted in pain relief and quality of life, making them valuable non-traditional exercise options for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part one: introduction, and mind-body exercise programs. Brosseau, L., Taki, J., Desjardins, B., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical value of ankle flexion and extension exercises combined with a psychological intervention in knee osteoarthritis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Testing a Positive Psychological Intervention for Osteoarthritis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Health-Led Cognitive Behavioral-Based Group Therapy on Pain, Functional Disability and Psychological Outcomes among Knee Osteoarthritis Patients in Malaysia. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

Group education and exercise is feasible in knee and hip osteoarthritis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Do I really want to be going on a bloody diet? Gendered narratives in older men with painful knee osteoarthritis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A qualitative study of the consequences of knee symptoms: 'It's like you're an athlete and you go to a couch potato'. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part one: introduction, and mind-body exercise programs. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. [2022]

11. Denmark pubmed.ncbi.nlm.nih.gov

Limited use of surgeon's advice on exercise for knee osteoarthritis. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Hip Strength Deficits in People With Symptomatic Knee Osteoarthritis: A Systematic Review With Meta-analysis. [2022]