Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

Mount Sinai Health System

Status: Active, not recruiting

Conditions: Chronic Pain; Knee Osteoarthritis

Treatments: Other: Technology-implemented exercise therapy; Other: Traditional Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06167304

STUDY-22-01430

Details and patient eligibility

About

The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (age ≥ 18 years)
• Living in the tristate area - CT/NY/NJ
• Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)
• Chronic knee pain (>3 months) as a primary pain complaint
• Average pain score ≥ 4 on an 11-point numeric rating scale at baseline
• Access to a device with internet connection
• KL Stages 1-2-3

Exclusion criteria

• Prior documented history of cognitive impairment;
• History of total knee arthroplasty;
• 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 knee injury, within the last 3 months;
• Currently engaged with other PT or strengthening program;
• Present unstable/uncontrolled cardiovascular condition
• Undergoing active chemotherapy for cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

Technology-implemented exercise therapy

Experimental group

Description:

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.

Treatment:

Other: Technology-implemented exercise therapy

Traditional Physical Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Traditional Physical Therapy