The Effect of AposTherapy on Knee Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months, fulfilling the 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 VAS pain score of ≥3cm (measured at baseline).

- Males and females between the ages of 40-75.

- 17Exclusion 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 COPD (exacerbation within 6 months) - No active malignancies on ongoing treatment - Patient with neurological gait pattern - Patient requiring assistive device during gait analysis.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03171168
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Montefiore Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Matthew Bartels, MD, MPH
Principal Investigator Affiliation	Montefiore Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis, Knee Pain

Additional Details

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.

Arms & Interventions

Arms

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.

Experimental: 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.

Interventions

Device: - AposTherapy

Other: - Traditional Physical Therapy

Up to 20 sessions of traditional physical therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Montefiore Medical Center - Moses Campus, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

Site Contact

Beendu P Pujar, MD

[email protected]

518-596-0510

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