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

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00457132
First received: April 4, 2007
Last updated: June 26, 2007
Last verified: April 2007
  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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)
  • Aggregated Locomotor Function (ALF)

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457132

Locations
Israel
Assaf-Harofeh Medical Center
Zerifin, Israel, 70600
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Nahum Halperin, MD Asaf-Harofeh Medical Center
  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 April 15, 2014