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A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee

NCT00118521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2013-12-19

No results posted yet for this study

Summary

Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition often treated in primary care. Both the individual and community are affected by this condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after first being afflicted. Importantly, it interferes with activities such as walking, jogging, gym classes and aerobics, which are often prescribed to prevent serious conditions of the heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our nation.

Two popular treatment options that are commonly prescribed for the management of patellofemoral pain syndrome are physiotherapy and foot orthotics. To date, there is some evidence supporting physiotherapy, especially current best practice methods, such as a combined program of therapeutic exercise, manual therapy and kneecap taping. There is a lack of evidence for the use of orthotics in treating patellofemoral pain syndrome.

This project will conduct a randomised clinical trial to evaluate the relative benefits of orthotics as the sole treatment of patellofemoral pain syndrome and also when combined with physiotherapy. Factors associated with predicting the results of orthotic therapy will be studied to see if there are any tests that a health care practitioner can perform to provide information early on in a consultation regarding possible treatment outcomes. A cost-benefit analysis will also be conducted to calculate the relative economic merits of the treatments.

A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating patellofemoral pain syndrome in primary health care.

Conditions

  • Patellofemoral Pain Syndrome

Interventions

PROCEDURE

Foot Orthotics

PROCEDURE

Physiotherapy

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Bill Vicenzino, PhD · The University of Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118521 on ClinicalTrials.gov