The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study
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Purpose
Context: The many treatments and devices developed to unload the diseased articular surface in knee osteoarthritis have provided limited solutions. A novel biomechanical device comprising of four individually calibrated elements attached onto foot-worn platforms was recently developed. This device is capable of such unloading during standing and walking, simultaneously strengthening dynamic stabilizers and training neuromuscular control by controlled biomechanical perturbations.
Objective: To asses the effectiveness of this device in reducing pain and improving function in patients with knee osteoarthritis.
Design and Setting: Randomized, controlled and double blind prospective trial, conducted from September 2005 to February 2006, in the Department of Orthopedics, Asaf Harofeh Medical Center (Zerifin, Israel).
Patients: Sixty-one patients with diagnosed knee osteoarthritis who self-reported moderate-to-severe level pain.
Interventions: Patients were randomly assigned into active and control groups and underwent 8 weeks of treatment. The active group was treated with the device and its four biomechanical elements that had been individually calibrated to accommodate a pain-free joint alignment. The control group was treated with the device’s platforms without the biomechanical elements.
Primary Outcome Measures: The patients were evaluated three times during the study: at baseline, after 4 weeks and at the 8 week endpoint. Primary outcomes were the Western Ontario and McMaster Osteoarthritis Index (WOMAC) and the Aggregated Locomotor Function (ALF) assessment.
| Condition | Intervention |
|---|---|
|
Knee Osteoarthritis |
Device: APOS biomechanical gait system |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Dynamic Wedging: A Novel Treatment for Knee Osteoarthritis |
- Western Ontario and McMaster Osteoarthritis Index (WOMAC)
- Aggregated Locomotor Function (ALF)
- SF-36 health survey
- Knee Society Score
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Study Completion Date: | February 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- radiographically assessed osteoarthritis of the knee graded 1 to 4 according to the Kellgren and Lawrence scale
- self reported moderate to severe level pain
Exclusion Criteria:
- acute septic arthritis
- predisposition to a tendency to fall
- lack of physical or mental ability to perform or comply with the treatment procedure
- diabetes mellitus
- history of pathological osteoporotic fracture
Contacts and Locations
More Information
No publications provided by Assaf-Harofeh Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00457132 History of Changes |
| Other Study ID Numbers: | 44/05 |
| Study First Received: | April 4, 2007 |
| Last Updated: | June 26, 2007 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Assaf-Harofeh Medical Center:
|
Knee Osteoarthritis WOMAC ALF Wedging |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013