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

NCT06167304 | Terminated

• 1 other identifier: STUDY-22-01430
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, activities of daily living (ADLs), sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.

  Baseline Week 0

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.

  Baseline Week 2

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-reported outcome measure assessing the patient's opinion about the health, symptoms, and functionality of their knee. It is a 42-item questionnaire, including 5 subscales rated 0-4, with higher score indicating more severe knee problems: symptoms, pain, ADLs, sports/recreation, and quality of life. Full scale from 0-100, with higher score indicating more severe knee problems.

  12 weeks

Secondary Outcomes (25)

• Brief Pain Inventory - short form (BPI-SF)

  Baseline Week 0

• Brief Pain Inventory

  Baseline Week 2

• Brief Pain Inventory

  12 weeks

• Patient Reported Outcomes Measurement Information System (PROMIS)

  Baseline Week 0

• Patient Reported Outcomes Measurement Information System (PROMIS)

  Baseline Week 2

Study Arms (2)

Technology-implemented exercise therapy

EXPERIMENTAL

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.

Other: Technology-implemented exercise therapy

Traditional Physical Therapy

ACTIVE COMPARATOR

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.

Other: Traditional Physical Therapy

Interventions

Traditional Physical Therapy OTHER

Traditional physical therapy per Standard of care.

Traditional Physical Therapy

Technology-implemented exercise therapy OTHER

Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.

Technology-implemented exercise therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Abilities Research Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Putrino

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 29, 2024
• Primary Completion: January 29, 2024
• Study Completion: February 12, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)