Laterally Wedged Insoles for Patients With Knee Osteoarthritis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01763515
First received: December 28, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.


Condition Intervention Phase
Osteoarthritis, Knee
Procedure: Laterally wedged insoles
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline in knee pain severity after 2 months. [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.


Secondary Outcome Measures:
  • Change from baseline in knee's functional degree after 2 months. [ Time Frame: Up to 2 months. ] [ Designated as safety issue: No ]
    Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laterally wedged insoles
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
Procedure: Laterally wedged insoles
Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.

Detailed Description:

Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic medial femorotibial knee OA,
  • Daily knee pain for at least 1 month in the last 3 months,
  • Radiographic evidence of medial femorotibial knee OA,
  • Normal erythrocyte sedimentation rate.

Exclusion Criteria:

  • Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
  • Knee joint lavage in past 3 months,
  • Intra-articular corticosteroid injection during the past 3 months,
  • Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763515

Locations
Iran, Islamic Republic of
Department of Rehabilitation, Alzahra Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Farnaz Dehghan, MD Isfahan University of Medical Sciences
  More Information

Publications:
Responsible Party: Farnaz Dehgan Hosseinabadi, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01763515     History of Changes
Other Study ID Numbers: 13913008
Study First Received: December 28, 2012
Last Updated: January 8, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Joint Diseases
Arthritis
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014