Patellofemoral Pain SyndromePhase 3NCT00118521
A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
A Phase 3 study testing Foot Orthotics and Physiotherapy in people with Patellofemoral Pain Syndrome, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Foot Orthotics and Physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteAustralia
- Study dates
- May 2004to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
Brisbane, Queensland, 4072
About this study
Official title: Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
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.
Read more
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.
Read the 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
- Being tested
- Foot Orthotics, Physiotherapy
- Keywords
- Anterior Knee Pain
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot OrthoticsProcedure or surgery
PhysiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Hospital Anxiety and Depression Scale
Patient Specific Functional Scale
Pressure pain threshold
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 176 participants
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Bill Vicenzino, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118521
- Sponsor's protocol ID
- 2003001023NHMRC
- Other IDs
- NHMRC#301037
- Status last verified
- Sep 2006
- First submitted
- 1 Jul 2005
- Last updated
- 19 Dec 2013
- Results posted
- No
Publications
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.
PubMed 23242955Collins 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.
PubMed 19270165Collins 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.
PubMed 18952682Vicenzino 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.
PubMed 18304317
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
- ClinicalTrials.gov ID
- NCT00118521
- Acronym / sponsor ID
- 2003001023NHMRC
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Anterior Knee Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- May 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot Orthotics | Procedure or surgery | – |
| Physiotherapy | Procedure or surgery | – |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Derived from this study: PubMed 23242955Collins 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.
- Derived from this study: PubMed 19270165Collins 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.
- Derived from this study: PubMed 18952682Collins 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.
- Derived from this study: PubMed 18304317Vicenzino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Vicenzino, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Foot Orthotics and Physiotherapy in people with Patellofemoral Pain Syndrome, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst and Usual Pain Visual Analogue Scale. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00118521, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.