Knee OsteoarthritisAposKneeNCT03171168
The Effect of AposTherapy on Knee Pain
A study testing AposTherapy and Traditional Physical Therapy in people with Knee Osteoarthritis and Knee Pain, run by Montefiore Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain
- What is being tested?
- AposTherapy and Traditional Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
About this study
Official title: The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Pain
- Being tested
- AposTherapy, Traditional Physical Therapy
- Keywords
- Gait Analysis, WOMAC, SF-36 (Short Form 36)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AposTherapyDevice
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).
Traditional Physical TherapyOther
Up to 20 sessions of traditional physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | 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. Receives: Other: Traditional Physical Therapy |
| AposTherapy | Experimental | 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. Receives: Device: AposTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (4)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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).
Measured: 24 weeks
6-min Walk Test
objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start30 Nov 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: Insufficient recruitment and end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Responsible party
- Principal investigator, Matthew Bartels, Montefiore Medical Center
- Investigators
- Matthew Bartels, MD, MPH, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171168
- Sponsor's protocol ID
- 2015-4842
- Acronym
- AposKnee
- Status last verified
- Nov 2022
- First submitted
- 21 Mar 2017
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17551881Verghese 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.
PubMed 12456852Elbaz 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.
PubMed 24383821Haim 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.
PubMed 23273535Drexler 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.
PubMed 22521468Segal 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.
PubMed 23692690Forkan 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.
PubMed 16506876Sihvonen 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.
PubMed 24369076Abbott 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.
PubMed 23313532Fitzgerald 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.
PubMed 25952351Lim 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.
PubMed 18576289Tanaka 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.
PubMed 23828186Skou 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.
PubMed 25937024
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03171168
- Acronym / sponsor ID
- AposKnee / 2015-4842
- Conditions
- Knee Osteoarthritis, Knee Pain
- Keywords
- Gait Analysis, WOMAC, SF-36 (Short Form 36)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment and end of funding
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Apos Medical and Sports Technology Ltd.
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 14 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyParticipants 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. |
| AposTherapy | Experimental | Device: AposTherapyParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AposTherapyAposTherapy 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). | Device | AposTherapy |
| Traditional Physical TherapyUp to 20 sessions of traditional physical therapy | Other | Traditional Physical Therapy |
Primary outcome
Knee Pain and Function
Time frame: 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.
4 secondary outcomes
Quality of Life by RAND SF-36 (RAND Corporation Short Form 36)
Time frame: 24 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function
Time frame: 24 weeks
Gait Assessment
Time frame: 24 weeks
6-min Walk Test
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17551881Jones 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.
- Background: PubMed 12456852Verghese 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.
- Background: PubMed 24383821Elbaz 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.
- Background: PubMed 23273535Haim 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.
- Background: PubMed 22521468Drexler 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.
- Background: PubMed 23692690Segal 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.
- Background: PubMed 16506876Forkan 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.
- Background: PubMed 24369076Sihvonen 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.
- Background: PubMed 23313532Abbott 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.
- Background: PubMed 25952351Fitzgerald 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.
- Background: PubMed 18576289Lim 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.
- Background: PubMed 23828186Tanaka 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.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Bartels, MD, MPH principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AposTherapy and Traditional Physical Therapy in people with Knee Osteoarthritis and Knee Pain, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain and Function (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171168, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.