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Laterally Wedged Insoles for Patients With Knee Osteoarthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763515
First Posted: January 9, 2013
Last Update Posted: January 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
  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: Intervention Model: Single Group Assignment
Masking: None (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 Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline in knee pain severity after 2 months. [ Time Frame: Up to 2 months ]
    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. ]
    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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 28, 2012
First Posted: January 9, 2013
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences:
Joint Diseases
Arthritis
Osteoarthritis

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