Knee Osteoarthritis, Knee Pain
Conditions
Keywords
Gait Analysis, WOMAC, SF-36 (Short Form 36)
Brief summary
AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with knee osteoarthritis since patients with knee osteoarthritis have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee OA, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.
Detailed description
AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). Capitalizing on the reported excellent adherence and clinical benefit of Apos Therapy in patients with significant lower limb arthritis, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in knee OA population. A potential use of AposTherapy as a replacement for traditional physical therapy may yield a less costly, more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence (patients often do not complete the sessions and have very poor adherence (about 50-60%) to home therapy programs), added cost of travel (which may be more than $100 per session for ambulette or access-a-ride for eligible patients), and the lack of continuation in an ongoing exercise program, leading to relapse and need for retreatment. Additionally, access to physical therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an alternative exercise program that will increase adherence, decrease total therapy visits, and improve patient's outcomes with decreased dependence on pain medications is a high priority from both patient care and cost management perspectives. AposTherapy potentially overcomes many of these issues with improving/modifying abnormal biomechanics (therefore decreasing pain), and a home-based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This biomechanical approach may significantly reduce pain and improve function in patients with knee OA. Capitalizing on the reported excellent adherence and clinical benefit of AposTherapy in patients with significant knee OA, the investigators propose to evaluate the biomechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement or supplant traditional pain medications, interventional pain procedures and physical therapy in an at-risk urban inner city population with knee OA.
Interventions
DEVICEAposTherapy
AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA).
OTHERTraditional Physical Therapy
Up to 20 sessions of traditional physical therapy
Sponsors
Apos Medical and Sports Technology Ltd.
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor is the only one masked in the study. Assessor is independent of the randomization, trial coordination, and care providers.
Intervention model description
Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months, fulfilling the American College of Rheumatology (ACR) clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale. * Patients with a Visual Analog Scale (VAS) pain score of ≥3cm (measured at baseline). * Males and females between the ages of 40-75. * 17\<BMI\<40 * Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking * Stable medical regimen (no recent changes to the pain medication within a month) * Able to walk at least 50 meters and scored positive on the STEADI test * Able to understand, read and sign the informed consent form * English or Spanish speaking
Exclusion criteria
* Patients suffering from acute septic arthritis. * Patients suffering from inflammatory joint disease such as rheumatoid arthritis. * Patients with diagnosis of avascular necrosis of the knee. * Patients with diagnosis of neuromuscular disease. * Patients with more than 3 falls in the last 12 months, OR any fall with an injury in the last 12 months. * Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure. * Patients with a history of pathological osteoporotic fracture * Patients with referred pain in the knees from back or hip joint symptoms. * Patients with severe back pain, ≥ 4 cm in visual analogue scale (0-10) \[1\] or radiating leg pain * Patients with generalized body pain (both upper and lower extremities, such as fibromyalgia * No major surgery to the affected limb and contralateral limb (e.g. no joint replacements or surgical fracture repair) * No major cardiovascular comorbidities (able to enroll in an active exercise program) * Patient started on lipid lowering medication in last 3 months * Any change in blood pressure medications * No recent physical therapy (no more recent than 6 months) on the affected limb * No active heart disease (ischemia or heart failure admissions within 6 months) and no active Chronic Obstructive Pulmonary Disease (COPD) (exacerbation within 6 months) * No active malignancies on ongoing treatment * Patient with neurological gait pattern * Patient requiring assistive device during gait analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Pain and Function | 24 weeks | Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life by RAND SF-36 (RAND Corporation Short Form 36) | 24 weeks | Health-related Quality of Life (QoL) as assessed using the RAND SF-36 (Short Form Health Survey). The RAND SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Composite scoring range is 0 to 100 across the 8 domains identified with a higher overall score defining a more favorable health state. |
| PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | 24 weeks | Pain and Function measured through PROMIS short forms. PROMIS measures specific domains of Physical Health (e.g., physical function, pain intensity, pain interference, fatigue, sleep disturbance); Mental Health (depressive symptoms, anxiety, anger); and Social Health (ability to participate in social roles and activities). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS domains use different terms to describe score ranges. For example, some domains use mild/moderate/severe whereas others use very high to very low. Cut points for assessment can also vary. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average referenced population. This could be a desirable or undesirable outcome. |
| Gait Assessment | 24 weeks | Objective assessment of the patients' gait assessed with gait analysis equipment. Equipment was used to measure the patients' cadence, or walking rate, in number of steps per minute (steps/min). |
| 6-min Walk Test | 24 weeks | objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Physical Therapy Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy | 17 |
| AposTherapy Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
AposTherapy: AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). | 37 |
| Total | 54 |
Baseline characteristics
| Characteristic | AposTherapy | Total | Traditional Physical Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 18 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 36 Participants | 13 Participants |
| Age, Continuous | 61.83 years | 61.01 years | 59.24 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 25 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 22 Participants | 7 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 0 Participants |
| Region of Enrollment United States | 37 participants | 54 participants | 17 participants |
| Sex: Female, Male Female | 30 Participants | 45 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 37 |
| other Total, other adverse events | 5 / 17 | 10 / 37 |
| serious Total, serious adverse events | 0 / 17 | 0 / 37 |
Outcome results
Primary
Knee Pain and Function
Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain.
Time frame: 24 weeks
Population: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Physical Therapy | Knee Pain and Function | 5.1 units on a scale | Standard Deviation 2.8 |
| AposTherapy | Knee Pain and Function | 3.2 units on a scale | Standard Deviation 2.1 |
Secondary
6-min Walk Test
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Time frame: 24 weeks
Population: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Physical Therapy | 6-min Walk Test | 1292 Feet | Standard Deviation 229 |
| AposTherapy | 6-min Walk Test | 1453 Feet | Standard Deviation 228 |
Secondary
Gait Assessment
Objective assessment of the patients' gait assessed with gait analysis equipment. Equipment was used to measure the patients' cadence, or walking rate, in number of steps per minute (steps/min).
Time frame: 24 weeks
Population: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. Data presented is for patients who completed 24 weeks of the study. Data reported is only on those who entered the study and not outcomes data. Cadence is in steps per minute as entered below. As an example, typical marching is at 120 steps per minute.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Physical Therapy | Gait Assessment | 93.7 Cadence (steps/minute) | Standard Deviation 20.1 |
| AposTherapy | Gait Assessment | 109.7 Cadence (steps/minute) | Standard Deviation 18.3 |
Secondary
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Pain and Function measured through PROMIS short forms. PROMIS measures specific domains of Physical Health (e.g., physical function, pain intensity, pain interference, fatigue, sleep disturbance); Mental Health (depressive symptoms, anxiety, anger); and Social Health (ability to participate in social roles and activities). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS domains use different terms to describe score ranges. For example, some domains use mild/moderate/severe whereas others use very high to very low. Cut points for assessment can also vary. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average referenced population. This could be a desirable or undesirable outcome.
Time frame: 24 weeks
Population: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Physical Therapy | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | 20.7 T-score | Standard Deviation 33.9 |
| AposTherapy | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | 19.1 T-score | Standard Deviation 41.9 |
Secondary
Quality of Life by RAND SF-36 (RAND Corporation Short Form 36)
Health-related Quality of Life (QoL) as assessed using the RAND SF-36 (Short Form Health Survey). The RAND SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Composite scoring range is 0 to 100 across the 8 domains identified with a higher overall score defining a more favorable health state.
Time frame: 24 weeks
Population: STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Physical Therapy | Quality of Life by RAND SF-36 (RAND Corporation Short Form 36) | 48.8 score on a scale | Standard Deviation 13.06 |
| AposTherapy | Quality of Life by RAND SF-36 (RAND Corporation Short Form 36) | 64.34 score on a scale | Standard Deviation 16 |