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

NCT ID: NCT00118521

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Anterior Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Foot Orthotics

Intervention Type: PROCEDURE

Physiotherapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Principal Investigators

Bill Vicenzino, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

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

Brisbane, Queensland, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 23242955 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19270165 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18952682 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18304317 (View on PubMed)

Other Identifiers

NHMRC#301037

Identifier Type: -

Identifier Source: secondary_id

2003001023NHMRC

Identifier Type: -

Identifier Source: org_study_id