Clinical trial NCT06167304: Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)
Official title: Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Chronic Pain
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline Week 0
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline Week 2
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Brief Pain Inventory - short form (BPI-SF)
timeFrame: Baseline Week 0
measure: Brief Pain Inventory
timeFrame: Baseline Week 2
measure: Brief Pain Inventory
timeFrame: 12 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline Week 0
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline Week 2
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 12 weeks
measure: PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
timeFrame: Baseline Week 0
measure: PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
timeFrame: Baseline Week 2
measure: PSEQ-2 (Pain Self efficacy questionnaire-SF 2)
timeFrame: 12 weeks
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline Week 0
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline Week 2
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: 12 weeks
measure: PGI-C (Patient global impression of change)
timeFrame: Baseline Week 0
measure: PGI-C (Patient global impression of change)
timeFrame: Baseline Week 2
measure: PGI-C (Patient global impression of change)
timeFrame: 12 weeks
measure: Tampa Kinesiophobia Scale (TSK)
timeFrame: Baseline Week 0
measure: Tampa Kinesiophobia Scale
timeFrame: Baseline Week 2
measure: Tampa Kinesiophobia Scale
timeFrame: 12 weeks
measure: Pain Catastrophizing Scale
timeFrame: Baseline Week 0
measure: Pain Catastrophizing Scale
timeFrame: Baseline Week 2
measure: Pain Catastrophizing Scale
timeFrame: 12 weeks
measure: Subjective questionnaire (ST arm)
timeFrame: 12 weeks
measure: Medication (PT arm)
timeFrame: 12 weeks
measure: Difficulty of exercises (PT arm)
timeFrame: 12 weeks
measure: Number of exercises completed (PT arm)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura Tabacof
role: PRINCIPAL_INVESTIGATOR
References: