Chronic Pain, Knee Osteoarthritis
Conditions
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.
Interventions
OTHERTechnology-implemented exercise therapy
Therapy plans are performed at home overseen by a remote physical therapist via SimpleTherapy.
OTHERTraditional Physical Therapy
Traditional physical therapy per Standard of care.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline Week 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory - short form (BPI-SF) | Baseline Week 0 | 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. |
| Brief Pain Inventory | Baseline Week 2 | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) | Baseline Week 0 | 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). |
| PSEQ-2 (Pain Self efficacy questionnaire-SF 2) | Baseline Week 0 | 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. |
| Work Productivity and Activity Impairment (WPAI) | Baseline Week 0 | 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). |
| PGI-C (Patient global impression of change) | Baseline Week 0 | 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. |
| Tampa Kinesiophobia Scale (TSK) | Baseline Week 0 | 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. |
| Tampa Kinesiophobia Scale | Baseline Week 2 | 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. |
| Pain Catastrophizing Scale | Baseline Week 0 | 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. |
| Subjective questionnaire (ST arm) | 12 weeks | 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. |
| Medication (PT arm) | 12 weeks | Questionnaire asking Yes/No for starting new prescribed medication or treatment (if yes, name of new medication/treatment is requested). |
| Difficulty of exercises (PT arm) | 12 weeks | 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. |
| Number of exercises completed (PT arm) | 12 weeks | Questionnaire tracking home exercise adherence (How many Exercises this week?). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Putrino
Icahn School of Medicine at Mount Sinai
Outcome results
None listed