The Effect of AposTherapy on Knee Pain

Knee Osteoarthritis Clinical Trial

— AposKnee  

Official title:

The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03171168
• Other study ID #: 2015-4842
• Status: Terminated
• Phase: N/A
• Start date: November 30, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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).

Other:
• Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Moses Campus	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Apos Medical and Sports Technology Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 weeks
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.	24 weeks
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.	24 weeks
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).	24 weeks
Secondary	6-min Walk Test	objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course	24 weeks