Clinical trial NCT03171168: The Effect of AposTherapy on Knee Pain
Official title: The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain
Keywords: Gait Analysis
WOMAC
SF-36 (Short Form 36)
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Apos Medical and Sports Technology Ltd.
First posted: 2017-05-31
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Pain and Function
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of Life by RAND SF-36 (RAND Corporation Short Form 36)
timeFrame: 24 weeks
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
timeFrame: 24 weeks
measure: Gait Assessment
timeFrame: 24 weeks
measure: 6-min Walk Test
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Matthew Bartels, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones KR, Vojir CP, Hutt E, Fink R. Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents. J Rehabil Res Dev. 2007;44(2):305-14. doi: 10.1682/jrrd.2006.05.0051.
citation: Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8. doi: 10.1056/NEJMoa020441.
citation: Elbaz A, Mor A, Segal G, Aloni Y, Teo YH, Teo YS, Das-De S, Yeo SJ. Patients with knee osteoarthritis demonstrate improved gait pattern and reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre study on Singaporean population. J Orthop Surg Res. 2014 Jan 2;9:1. doi: 10.1186/1749-799X-9-1.
citation: Haim A, Segal G, Elbaz A, Mor A, Agar G, Bar-Ziv Y, Beer Y, Morag G, Debi R, Atoun E. The outcome of a novel biomechanical therapy for patients suffering from anterior knee pain. Knee. 2013 Dec;20(6):595-9. doi: 10.1016/j.knee.2012.11.009. Epub 2012 Dec 27.
citation: Drexler M, Elbaz A, Mor A, Debi R, Debbi EM, Haim A, Lador R, Salai M, Segal G. Effects of a customized biomechanical therapy on patients with medial compartment knee osteoarthritis. Ann Phys Rehabil Med. 2012 May;55(4):213-28. doi: 10.1016/j.rehab.2012.01.002. Epub 2012 Mar 27. English, French.
citation: Segal G, Bar-Ziv Y, Velkes S, Benkovich V, Stanger G, Debbi EM, Debi R, Mor A, Elbaz A. A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg Res. 2013 May 21;8:13. doi: 10.1186/1749-799X-8-13.
citation: Forkan R, Pumper B, Smyth N, Wirkkala H, Ciol MA, Shumway-Cook A. Exercise adherence following physical therapy intervention in older adults with impaired balance. Phys Ther. 2006 Mar;86(3):401-10.
citation: Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
citation: Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8.
citation: Fitzgerald GK, Hinman RS, Zeni J Jr, Risberg MA, Snyder-Mackler L, Bennell KL. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):803-14. doi: 10.1016/j.joca.2015.03.013.
citation: Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.
citation: Tanaka R, Ozawa J, Kito N, Moriyama H. Efficacy of strengthening or aerobic exercise on pain relief in people with knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2013 Dec;27(12):1059-71. doi: 10.1177/0269215513488898. Epub 2013 Jul 4.
citation: Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30.