Clinical trial NCT00118521: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patellofemoral Pain Syndrome
Keywords: Anterior Knee Pain
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-07-11
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Worst and Usual Pain Visual Analogue Scale
measure: Functional Index Questionnaire
measure: Anterior Knee Pain Scale
measure: Patient Perceived Treatment Effect score
measure: Perceived Global Effect 5 Point Scale
Secondary outcomes:
measure: Physical activity level in previous week
measure: Step up, step down and squat tests
measure: Lower Extremity Functional Scale
measure: McGill Pain Questionnaire
measure: SF-36 Health Survey
measure: Hospital Anxiety and Depression Scale
measure: Patient Specific Functional Scale
measure: Pressure pain threshold
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Bill Vicenzino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.