The Effect of AposTherapy on Knee Pain (AposKnee)
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|ClinicalTrials.gov Identifier: NCT03171168|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Knee Pain||Device: AposTherapy Other: Traditional Physical Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.|
|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.|
|Official Title:||The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial|
|Actual Study Start Date :||November 30, 2016|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||January 30, 2020|
Active Comparator: 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.
Other: Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy
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 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).
- Knee Pain and Function [ Time Frame: 1 year ]Improvement in Pain and Function Assessed with a questionnaire
- Quality of life [ Time Frame: 1 year ]Assessed with a questionnaire -SF-36 (Short Form Health Survey)
- PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function [ Time Frame: 1 year ]Pain and Function measured through PROMIS short forms.
- Medication Costs [ Time Frame: 1 year ]Change in Medication costs assessed by patient interview.
- Healthcare utilization [ Time Frame: 1 year ]Change in healthcare facility utilization assessed by patient interview.
- Gait assessment [ Time Frame: 1 year ]Objective assessment of the patients' gait assessed with gait analysis equipment
- Pain medication consumption [ Time Frame: 1 year ]Medication consumption
- 6-min walk test [ Time Frame: 1 year ]objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
- Blood pressure [ Time Frame: 1 year ]Increase/ decrease in Blood Pressure, physiological parameter
- resting heart rate [ Time Frame: 1 year ]Increase/ decrease in resting heart rate, physiological parameter
- Overall activity [ Time Frame: 1 year ]Measure in daily steps taken assessed with a wristband device
- sleep patterns [ Time Frame: 1 year ]Measured as total sleep time in minutes assessed with a wristband device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171168
|Contact: Sewon Lee, MDemail@example.com|
|Contact: Matthew N Bartels, MD, MPHfirstname.lastname@example.org|
|United States, New York|
|Montefiore Medical Center - Moses Campus||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Beendu P Pujar, MD 518-596-0510 email@example.com|
|Principal Investigator: Matthew N Bartels, MD, MPH|
|Principal Investigator:||Matthew Bartels, MD, MPH||Montefiore Medical Center|