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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Foot Orthotics
Physiotherapy
Sponsored by
The University of Queensland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Anterior Knee Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland

Outcomes

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

Full Information

First Posted
July 1, 2005
Last Updated
December 18, 2013
Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00118521
Brief Title
A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
Official Title
Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Anterior Knee Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
176 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Foot Orthotics
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Primary Outcome Measure Information:
Title
Worst and Usual Pain Visual Analogue Scale
Title
Functional Index Questionnaire
Title
Anterior Knee Pain Scale
Title
Patient Perceived Treatment Effect score
Title
Perceived Global Effect 5 Point Scale
Secondary Outcome Measure Information:
Title
Physical activity level in previous week
Title
Step up, step down and squat tests
Title
Lower Extremity Functional Scale
Title
McGill Pain Questionnaire
Title
SF-36 Health Survey
Title
Hospital Anxiety and Depression Scale
Title
Patient Specific Functional Scale
Title
Pressure pain threshold

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill Vicenzino, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23242955
Citation
Collins NJ, Bierma-Zeinstra SM, Crossley KM, van Linschoten RL, Vicenzino B, van Middelkoop M. Prognostic factors for patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2013 Mar;47(4):227-33. doi: 10.1136/bjsports-2012-091696. Epub 2012 Dec 13.
Results Reference
derived
PubMed Identifier
19270165
Citation
Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br J Sports Med. 2009 Mar;43(3):169-71. doi: 10.1136/bmj.a1735.
Results Reference
derived
PubMed Identifier
18952682
Citation
Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. BMJ. 2008 Oct 24;337:a1735. doi: 10.1136/bmj.a1735.
Results Reference
derived
PubMed Identifier
18304317
Citation
Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial. BMC Musculoskelet Disord. 2008 Feb 27;9:27. doi: 10.1186/1471-2474-9-27.
Results Reference
derived

Learn more about this trial

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

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