Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118521
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
The University of Queensland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Procedure: Foot Orthotics Procedure: Physiotherapy Phase 3

Detailed Description:
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
Study Start Date : May 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Worst and Usual Pain Visual Analogue Scale
  2. Functional Index Questionnaire
  3. Anterior Knee Pain Scale
  4. Patient Perceived Treatment Effect score
  5. Perceived Global Effect 5 Point Scale

Secondary Outcome Measures :
  1. Physical activity level in previous week
  2. Step up, step down and squat tests
  3. Lower Extremity Functional Scale
  4. McGill Pain Questionnaire
  5. SF-36 Health Survey
  6. Hospital Anxiety and Depression Scale
  7. Patient Specific Functional Scale
  8. Pressure pain threshold

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00118521


Locations
Layout table for location information
Australia, Queensland
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
Brisbane, Queensland, Australia, 4072
Sponsors and Collaborators
The University of Queensland
National Health and Medical Research Council, Australia
Investigators
Layout table for investigator information
Principal Investigator: Bill Vicenzino, PhD The University of Queensland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00118521     History of Changes
Other Study ID Numbers: 2003001023NHMRC
NHMRC#301037
First Posted: July 11, 2005    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: September 2006
Keywords provided by The University of Queensland:
Anterior Knee Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Patellofemoral Pain Syndrome
Syndrome
Disease
 Pathologic Processes
Joint Diseases
Musculoskeletal Diseases