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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a program called Positive Minds, Strong Joints, which combines mental health support and group exercise to assist Black adults with knee osteoarthritis. The goal is to determine if this approach improves the management of knee pain and mental health. Participants will engage in weekly online mental health sessions and community exercise classes over ten weeks. This trial suits Black adults who have recently experienced knee pain and are open to trying both mental health and physical exercise interventions. As an unphased trial, it offers participants the opportunity to contribute to innovative research that may enhance holistic care for knee osteoarthritis.

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 prior data suggests that this intervention is safe for Black adults with knee osteoarthritis?

Research shows that specific safety information for the "Positive Minds, Strong Joints" treatment is not yet available. This program combines mental health support with physical exercise. As an early study, it focuses on assessing the treatment's practicality for participants rather than collecting detailed safety data.

The program includes weekly mental health sessions and community exercise, which are generally safe activities. Both mental health support and regular exercise are usually well-tolerated and beneficial for overall health. However, because this study is in its early stages, detailed safety information specific to this treatment might not be available. Those interested in joining should discuss any concerns with the research team to better understand possible risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Positive Minds, Strong Joints because it takes a fresh approach to managing knee osteoarthritis. Unlike traditional treatments like pain medications, physical therapy, or surgery, this method combines mental health support with community-based exercises. By offering a weekly mental health intervention through Zoom and group exercise sessions, it aims to tackle both the psychological and physical aspects of the condition simultaneously. This dual approach could potentially provide more comprehensive relief and improve overall well-being for patients.

What evidence suggests that the Positive Minds, Strong Joints intervention could be effective for knee osteoarthritis?

Research suggests that the Positive Minds, Strong Joints program, provided to participants in this trial, could benefit people with knee osteoarthritis by integrating mental health support with physical exercise. Studies have shown that cultivating positive mental habits, such as gratitude, can reduce pain and improve movement for those with knee osteoarthritis. This approach targets both mental and physical health, potentially enhancing participants' overall quality of life. Although this program remains under evaluation, combining mental and physical health strategies may offer a promising method for managing knee osteoarthritis symptoms. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/298195/positive-minds-strong-joints-for-knee-osteoarthritis/

Positive Minds Strong Joints for Knee Osteoarthritis The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) ...

2. withpower.com withpower.com/trial/phase-osteoarthritis-knee-8-2024-a6044

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.

3. bu.trialstoday.org bu.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMLIwNTEwNlbS0bWEAR0jHUNzEzMDU3MzAxDQUcpLLjEwszQwMTE1U4oFAN7TDnk-

Boston University - Clinical & Translational Science Institute Positive Minds Strong Joints for Knee Osteoarthritis​​ The aim of this research study is to test the feasibility of a physical and mental health intervention ( ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/109/osteoarthritis?dt_type=updated&page=5

Osteoarthritis Clinical Research Trials Positive Minds Strong Joints for Knee Osteoarthritis. In this feasibility study, at least 20 and up to 40 Black Adults will be enrolled to receive PMSJ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487322/

Collaborative model of care between orthopaedics and ... Knee osteoarthritis (OA) is one of the largest and fastest growing causes of pain, disability and poor quality of life, particularly in the ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT06493903

Positive Minds Strong Joints for Knee Osteoarthritis 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6390843/

Intra-articular treatment options for knee osteoarthritis - PMC Nevertheless, the results from the first-inhuman, 24-week, phase I RCT revealed SM04690 to be safe and well-tolerated and showed no evidence of exposure outside ...