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NCT06167304 | RECRUITING | Knee Osteoarthritis

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

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Laura Tabacof

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.

Condition or disease

Knee Osteoarthritis

Chronic Pain

Intervention/treatment

Technology-implemented exercise therapy

Traditional Physical Therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 220 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial
Actual Study Start Date : 2024-01-29
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

Location Details

NCT06167304

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How to Participate

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Locations

RECRUITING

United States, New York

Abilities Research Center

New York, New York, United States, 10029