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

Digital Home Exercise Program Versus Standard of Care for Chronic OA-related Knee Pain: a Non-inferiority Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Knee Osteoarthritis
• Intervention / Treatment: Other: Technology-implemented exercise therapy; Other: Traditional Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Salazar; Phone Number: 212-241-8454; Email: sophia.salazar@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Abilities Research Center
      • Contact: Sophia I Salazar, BSc; Phone Number: 212-241-8454; Email: sophia.salazar@mssm.edu
      • Contact: Mackenzie Doerstling; Phone Number: 212-241-8454; Email: mackenzie.doerstling@mountsinai.org
      • Principal Investigator: Laura Tabacof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technology-implemented exercise therapy; 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; Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.
Active Comparator: Traditional Physical Therapy; 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; Traditional physical therapy per Standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory	The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.	Baseline Week 2
Brief Pain Inventory	The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.	12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)	Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).	Baseline Week 0
Patient Reported Outcomes Measurement Information System (PROMIS)	Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).	Baseline Week 2
Patient Reported Outcomes Measurement Information System (PROMIS)	Measures are based on "item banks," sets of items that represent symptom or functional domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The T-score is provided with an error term (Standard Error or SE, 95% confidence interval).	12 weeks
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)	Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.	Baseline Week 0
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)	Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.	Baseline Week 2
PSEQ-2 (Pain Self efficacy questionnaire-SF 2)	Assesses pain self-efficacy, which is a belief in one's ability to carry out activities even when in pain. The PSEQ-2 is a shorter version of PROMISE Self-Efficacy for Managing Chronic pain and it has been clinically validated. PSEQ-2 includes two items scored on a 7-point Likert scale (0- not at all confident to 6- Completely confident) which are added to form a total score ranging from 0 to 12. High scores indicate greater self-efficacy.	12 weeks
PGI-C (Patient global impression of change)	Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.	Baseline Week 0
PGI-C (Patient global impression of change)	Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.	Baseline Week 2
PGI-C (Patient global impression of change)	Captures perception of change in activity, limitations, feelings, emotions and health related QOL related to pain. PGIC is a 7 point scale depicting a patient's overall improvement rating. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." Measure correlations of patient ratings of importance of change with the magnitude of that change. The PGI-I is a transition scale that is a single question asking the patient to rate their condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.	12 weeks
Tampa Kinesiophobia Scale	TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.	Baseline Week 2
Tampa Kinesiophobia Scale	TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.	12 weeks
Pain Catastrophizing Scale	13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Baseline Week 0
Pain Catastrophizing Scale	13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	Baseline Week 2
Pain Catastrophizing Scale	13-item self reported measure designed to assess catastrophic thinking related to pain among adults. Using a 5-point Likert scale, from 0 (not at all) to 4 (always), people are asked to rate how often they experience the mentioned thoughts and feelings when they are in pain. Along with three subscale scores evaluating rumination, magnification, and helplessness, the overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization.	12 weeks
Subjective questionnaire (ST arm)	6-item questionnaire (yes/no) assessing accessibility, satisfaction with care and pain management, enjoyment, referral to friends or colleagues, and one open answer on recommendations for the exercise intervention.	12 weeks
Medication (PT arm)	Questionnaire asking Yes/No for starting new prescribed medication or treatment (if yes, name of new medication/treatment is requested).	12 weeks
Difficulty of exercises (PT arm)	Questionnaire tracking difficulty of exercises (0-not difficult at all, to 10- Extremely Difficult), total score ranges 0-10, with higher scores indicating greater difficulty.	12 weeks
Number of exercises completed (PT arm)	Questionnaire tracking home exercise adherence (How many Exercises this week?).	12 weeks
Brief Pain Inventory - short form (BPI-SF)	The BPI -SF rates severity pain and the degree to which pain interferes with common dimensions of feeling and function. It includes 9 items (0-No pain to 10-Pain as bad as you can imagine) and results in two scores ranging between 0-10: Pain Intensity and Pain Interference, with higher score indicating worse outcomes.	Baseline Week 0
Work Productivity and Activity Impairment (WPAI)	WPAI measures impairments in work and activities. The WPAI yields four types of scores: A. Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).	Baseline Week 0
Work Productivity and Activity Impairment (WPAI)	WPAI measures impairments in work and activities. The WPAI yields four types of scores: A. Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).	Baseline Week 2
Work Productivity and Activity Impairment (WPAI)	WPAI measures impairments in work and activities. The WPAI yields four types of scores: A. Absenteeism B. Presenteeism C. Work productivity loss (overall work impairment / absenteeism plus presenteeism; D. Activity Impairment WPAI outcomes are expressed as impairment percentages (0%-100%), with higher numbers indicating greater impairment and less productivity (worse outcomes).	12 weeks
Tampa Kinesiophobia Scale (TSK)	TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. Individual item scores range from 1-4, with the negatively worded items having a reverse scoring. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.	Baseline Week 0

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Laura Tabacof, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Chronic Pain
• Other Study ID Numbers: STUDY-22-01430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only sharing analyzed deidentified information, not individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No