The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study

NCT00457132 | Completed

• 1 other identifier: 44/05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; WOMAC; ALF; Wedging

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Osteoarthritis Index (WOMAC)

• Aggregated Locomotor Function (ALF)

Secondary Outcomes (2)

• SF-36 health survey

• Knee Society Score

Interventions

APOS biomechanical gait system DEVICE

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radiographically assessed osteoarthritis of the knee graded 1 to 4 according to the Kellgren and Lawrence scale
• self reported moderate to severe level pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70600, Israel

Location

Related Publications (1)

• Bar-Ziv Y, Beer Y, Ran Y, Benedict S, Halperin N. A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study. BMC Musculoskelet Disord. 2010 Aug 10;11:179. doi: 10.1186/1471-2474-11-179.

  PMID: 20698991 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nahum Halperin, MD

  Asaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: September 1, 2005
• Study Completion: February 1, 2006
• Last Updated: June 27, 2007

Record last verified: 2007-04

Locations

IL (1)