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OpenTrials
Completed

NCT Number: NCT00415259

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, 3010, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laterally wedged shoe insoles

Device

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Control insole group

Device

Flat control insoles worn inside the shoes daily for 12 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2006
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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