The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
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
|Study Start Date:||September 2005|
|Study Completion Date:||February 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457132
|Assaf-Harofeh Medical Center|
|Zerifin, Israel, 70600|
|Principal Investigator:||Nahum Halperin, MD||Asaf-Harofeh Medical Center|