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Behavioural Intervention

Physical Therapy vs Remote Exercise for Osteoarthritis

N/A

Recruiting

Led By Laura Tabacof

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)

KL Stages 1-2-3

Must not have

History of inflammatory arthritis (e.g. rheumatoid arthritis) or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days, fall within 90 days, high risk of fracture

History of total knee arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if home exercise with SimpleTherapy can help people with knee OA as much as physical therapy.

Who is the study for?

This trial is for adults over 18 living in CT/NY/NJ with knee pain from osteoarthritis, who've had this pain for more than 3 months and have an average pain score of at least 4 out of 11. They must have internet access and be in the early to moderate stages of OA. People with cognitive impairments, recent surgeries or falls, severe heart disease, bleeding disorders, or those already doing physical therapy can't join.

What is being tested?

The study compares two ways to treat knee pain due to osteoarthritis: traditional physical therapy versus a home-based exercise program called SimpleTherapy. Participants will follow their assigned treatment three times a week for six weeks to see if the remote exercise is as effective as regular physical therapy.

What are the potential side effects?

Since this trial involves non-drug therapies (physical exercises), side effects may include muscle soreness, joint discomfort or fatigue related to exercise. Serious side effects are unlikely but could involve injury if exercises are not performed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have painful osteoarthritis according to official health guidelines.

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My knee arthritis is mild to moderate.

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I have had knee pain for more than 3 months.

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My average pain level is 4 or higher on a scale of 0 to 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no history of severe arthritis, neuropathies, recent surgery, falls, or conditions that increase fracture risk.

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I have had a total knee replacement surgery.

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My heart condition is not stable or under control.

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I am currently receiving chemotherapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary study objectives

Brief Pain Inventory

Brief Pain Inventory - short form (BPI-SF)

Difficulty of exercises (PT arm)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Technology-implemented exercise therapyExperimental Treatment1 Intervention

Therapy plans performed at home overseen by a remote physical therapist via SimpleTherapy. Allocation to this group will require using smart devices or a computer/laptop to receive care. Remote visits with a PT typically last 45min long and home exercises suggested by the app are self-paced.

Group II: Traditional Physical TherapyActive Control1 Intervention

Participants will be prescribed an exercise plan by a physical therapist as normally would occur as part of standards of care outside the context of a research study. In-person assessments and at-home exercise suggestions will be decided by the physical therapist. Duration of PT appointments is typically 45 minutes long two times per week and are supplemented by PT recommended self-paced at-home exercises.

0 / 8Eligibility criteria met