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.

Official Title

Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care


Patellofemoral Pain Syndrome

Study Type


Study Design

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

  • Worst and Usual Pain Visual Analogue Scale
  • Functional Index Questionnaire
  • Anterior Knee Pain Scale
  • Patient Perceived Treatment Effect score
  • Perceived Global Effect 5 Point Scale

Secondary Outcome Measures:

  • Physical activity level in previous week
  • Step up, step down and squat tests
  • Lower Extremity Functional Scale
  • McGill Pain Questionnaire
  • SF-36 Health Survey
  • Hospital Anxiety and Depression Scale
  • Patient Specific Functional Scale
  • Pressure pain threshold

Study Start

May 2004; Expected completion: July 2007

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years – 40 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of patellofemoral pain syndrome (non traumatic origin) of at least 6 weeks duration
  • Pain with at least 2 of the following activities: stair walking, jogging/running, squatting, hopping/jumping, kneeling or prolonged sitting

Exclusion Criteria:

  • Concomitant injury or pathology of other knee joint structures, eg. meniscal, ligamentous etc.
  • Pain in or referred from the lumbar spine and hip
  • History of knee fractures, patellar dislocation/subluxation with a positive apprehension test
  • Prior physiotherapy treatment (including patellar taping) within the past 12 months
  • History of allergic reaction to adhesive tape
  • Current or previous foot orthotic use
  • Any condition of the foot that precludes orthotic therapy

Total Enrolment


Contact Details

Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland, Brisbane, Queensland, 4072, Australia; Recruiting

  • Bill Vicenzino, PhD 61-7-33652781

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