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

NCT00118521 | Completed Phase 3

• 2 other identifiers: 2003001023NHMRCNHMRC#301037
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Anterior Knee Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Physical activity level in previous week

• Step up, step down and squat tests

• Lower Extremity Functional Scale

• McGill Pain Questionnaire

• SF-36 Health Survey

Interventions

Foot Orthotics PROCEDURE

Physiotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

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

Brisbane, Queensland, 4072, Australia

Location

Related Publications (4)

• 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.

  PMID: 23242955 DERIVED

• 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.

  PMID: 19270165 DERIVED

• 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.

  PMID: 18952682 DERIVED

• 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.

  PMID: 18304317 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Bill Vicenzino, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 11, 2005
• Study Start: May 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 19, 2013

Record last verified: 2006-09

Locations

AU (1)