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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167304
• Other study ID #: STUDY-22-01430
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Sophia Salazar
• Phone: 212-241-8454
• Email: sophia.salazar[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis

Intervention

Other:
• Technology-implemented exercise therapy
Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.
• Traditional Physical Therapy
Traditional physical therapy per Standard of care.

Locations

Country	Name	City	State
United States	Abilities Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of exercises completed (PT arm)	Questionnaire tracking home exercise adherence (How many Exercises this week?).	12 weeks