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

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier:
NCT00415259
First received: December 21, 2006
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 Intervention
Osteoarthritis
Device: Laterally wedged shoe insoles
Device: Control insole group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Knee pain via a visual analogue scale [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
  • Disease progression via MRI measurements of knee cartilage volume [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
  • Patient perceived response to treatment [ Time Frame: Measured at baseline and 12 months. ] [ Designated as safety issue: No ]
  • Health-related quality-of-life (via SF-36, AQoL questionnaires) [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]
  • Recorded use of health care [ Time Frame: Measured at baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided by University of Melbourne

Additional 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
Study First Received: December 21, 2006
Last Updated: January 15, 2013
Health Authority: Australia: National Health and Medical Research Council
Australia: Department of Human Services Radiation Safety Commitee
Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014