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Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00415259
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : January 17, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.

Condition or disease Intervention/treatment
Osteoarthritis Device: Laterally wedged shoe insoles Device: Control insole group

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Study Start Date : May 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Device: Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Flat control insoles Device: Control insole group
Flat control insoles worn inside the shoes daily for 12 months


Outcome Measures

Primary Outcome Measures :
  1. Knee pain via a visual analogue scale [ Time Frame: Measured at baseline and 12 months ]
  2. Disease progression via MRI measurements of knee cartilage volume [ Time Frame: Measured at baseline and 12 months ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index [ Time Frame: Measured at baseline and 12 months ]
  2. Patient perceived response to treatment [ Time Frame: Measured at baseline and 12 months. ]
  3. Health-related quality-of-life (via SF-36, AQoL questionnaires) [ Time Frame: Measured at baseline and 12 months ]
  4. Recorded use of health care [ Time Frame: Measured at baseline and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligibility will be confirmed by radiographic and clinical examination
  • People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking >3 on an 11-point scale
  • varus knee malalignment on standing anteroposterior lower limb x-ray.

Exclusion Criteria:

  • advanced radiographic knee OA (Kellgren and Lawrence stage 4
  • knee surgery or intra-articular corticosteroid injection within 6 months
  • current or past (within 4 weeks) oral corticosteroid use
  • systemic arthritic conditions
  • history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
  • any other muscular, joint or neurological condition affecting lower limb function
  • ankle/foot pathology or pain that precludes the use of insoles
  • use of foot orthotics within past 6 months and
  • use of footwear that does not accomodate an insole.
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): NCT00415259


Locations
Australia, Victoria
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
University of Melbourne
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Kim Bennell, PhD University of Melbourne
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Bennell, Professor Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier: NCT00415259     History of Changes
Other Study ID Numbers: 350297
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Disease Progression
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes