Health TrialsbyHealthPanel

Positive Minds Strong Joints for Knee Osteoarthritis

ConditionOsteoarthritis, Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorBoston University Charles River Campus

About 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 does not accept healthy volunteers

Qualifiers

Age≥50

BMI ≤ 40 kg/m2

Self-identify as Black (including African American)

Knee pain ≥4/10 on a 11 numeric scale over the past week

Disqualifiers

Knee, hip or ankle replacement

Intra-articular corticosteroid or hyaluronic acid knee injection within 3 months

Knee surgery within past 6 months

Currently receiving or received within 3-months any PT for knee OA

Trial design

Design model

Single group

Treatments tested in this trial

  • Positive Minds, Strong Joints

    Behavioral

    In this10-week physical and mental health intervention, participants will receive recommended exercise intervention and evidence-based mental health intervention for pain, depression and anxiety.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Positive Minds Strong JointsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

Number of participants enrolled out of those screened

Time frame
Throughout the recruitment process
2

Retention

Proportion of participants who complete patient-reported outcome surveys at 10 week timepoint

Time frame
From the start of the study to end of the 10 week intervention
3

Attendance

Proportion of participants that attended at least 80% of intervention sessions

Time frame
During 10 weeks intervention period
4

Satisfaction with treatment

Custom 2-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e., Positive Minds, Strong Joints). There are 2 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.

Time frame
week 10 and week 22

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcome Score

Patient-reported outcome for knee pain and disability; a score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

Time frame
Baseline, week 5, week 10, week 16 and week 22
2

Patient Health Questionnaire 9-item

9-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-27. Higher total scores indicate greater severity of depression

Time frame
Baseline, week 5, week 10, week 16 and week 22
3

Generalized anxiety 7-item scale

It assesses anxiety symptoms. Each question is scored from 0 to 3 and the sum value of individual questions is the total score with range form 0-21. Higher total scores indicate greater severity of anxiety

Time frame
Baseline, week 5, week 10, week 16 and week 22
4

Arthritis Self Efficacy Scale

It measures confidence in one's capacity to function despite pain. Scores range from 1 (very uncertain) to 10 (very certain). It has three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Higher scores indicate greater self-efficacy to manage osteoarthritis.

Time frame
Baseline, week 10, and week 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University Charles River Campus

Lead sponsor

Rheumatology Research Foundation

Collaborator

Source ClinicalTrials.gov
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