Patellofemoral Pain SyndromePhase 1/2NCT01332110
Treatment for Patellofemoral Pain Syndrome Using Footwear
A Phase 1/2 study testing Knee abduction moment-reducing footwear in people with Patellofemoral Pain Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be associated with higher than normal knee joint loading. Footwear has been developed that may decrease these knee loads in healthy subjects, but their effects on patients with PFPS are unknown. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Knee abduction moment-reducing footwear
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Aug 2012
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female between 18 and 45 years of age.
- Have been diagnosed with patellofemoral pain syndrome (PFPS) by a physician.
- Have nontraumatic unilateral and/or bilateral peripatellar or retropatellar knee pain.
- Patellofemoral knee pain with and/or after activity.
- Inactivity patellofemoral pain and/or stiffness, especially with sitting with knees held in flexed posture.
- Peripatellar tenderness ± mild inferior patellar pole tenderness.
- Run at least 15km per week.
- Are heel-toe runners (as opposed to forefoot strikers).
Who cannot join
- Are currently, or have previously, participated in any other forms of treatment for their knee pain.
- Significant articular or periarticular effusion or bursitis.
- Significant joint line tenderness.
- Intra-articular ligamentous instability.
- Patellar apprehension.
- Have undergone any form of knee surgery or arthroscopy.
- Have any other neuromuscular, musculoskeletal or cardiovascular conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear
Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be associated with higher than normal knee joint loading. Footwear has been developed that may decrease these knee loads in healthy subjects, but their effects on patients with PFPS are unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We hypothesize that patients who receive the footwear intervention will show a decrease in knee joint loading, and consequently will show improvements in subjective levels of perceived knee pain over a period of six weeks compared to a control condition.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Knee abduction moment-reducing footwear
- Keywords
- Footwear, Motion Analysis, Running Injury
- 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.
Knee abduction moment-reducing footwearDevice
Patients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention.
| Study group | Role | What they receive |
|---|---|---|
| Knee abduction moment-reducing footwear | Experimental | Footwear that is known to decrease knee abduction moments of force in healthy subjects. May include orthotics, or footwear that allows relative movement between the heel section of the outsole and rest of the shoe. Receives: Device: Knee abduction moment-reducing footwear |
| Control footwear | Placebo comparator | Standard, off-the-shelf running shoes with no mechanical modifications. Receives: Device: Knee abduction moment-reducing footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint internal abduction moments of force during running at 4m/s
Motion analysis trials will be conducted on each subject with both the control and intervention footwear. Inverse dynamics calculations will reveal the internal joint loading for each subject. Knee joint moments will be compared within subjects for each footwear condition.
Measured: First day of joining the study
Secondary outcomes (1)
Change in subjective levels of perceived knee pain over six weeks
Pain levels will be recorded by 100mm visual analog scale during weeks 1, 2, 3, 4, 5 and 6 of the study to monitor the efficacy of the intervention. Final change in pain will be compared between groups.
Measured: Upon initial recruitment to the study, and once per week for six weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Ryan Lewinson, University of Calgary
- Investigators
- Darren J. Stefanyshyn, Ph.D. P.Eng., Principal investigator, University of CalgaryRyan T. Lewinson, B.Sc., Principal investigator, University of CalgaryJay T. Worobets, Ph.D., Principal investigator, University of CalgaryJ. Preston Wiley, M.D., M.P.E., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332110
- Sponsor's protocol ID
- 23731
- Status last verified
- Feb 2014
- First submitted
- 7 Apr 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
Publications
Lewinson RT, Wiley JP, Humble RN, Worobets JT, Stefanyshyn DJ. Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial. PLoS One. 2015 Jul 31;10(7):e0134461. doi: 10.1371/journal.pone.0134461. eCollection 2015.
PubMed 26230399
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Patellofemoral Pain Syndrome Using Knee Abduction Moment-Reducing Footwear
- ClinicalTrials.gov ID
- NCT01332110
- Acronym / sponsor ID
- 23731
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Footwear, Motion Analysis, Running Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Apr 2011 (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.
Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be associated with higher than normal knee joint loading. Footwear has been developed that may decrease these knee loads in healthy subjects, but their effects on patients with PFPS are unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We hypothesize that patients who receive the footwear intervention will show a decrease in knee joint loading, and consequently will show improvements in subjective levels of perceived knee pain over a period of six weeks compared to a control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee abduction moment-reducing footwear | Experimental | Device: Knee abduction moment-reducing footwearFootwear that is known to decrease knee abduction moments of force in healthy subjects. May include orthotics, or footwear that allows relative movement between the heel section of the outsole and rest of the shoe. |
| Control footwear | Placebo comparator | Device: Knee abduction moment-reducing footwearStandard, off-the-shelf running shoes with no mechanical modifications. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or Female between 18 and 45 years of age.
- Have been diagnosed with patellofemoral pain syndrome (PFPS) by a physician.
- Have nontraumatic unilateral and/or bilateral peripatellar or retropatellar knee pain.
- Patellofemoral knee pain with and/or after activity.
- Inactivity patellofemoral pain and/or stiffness, especially with sitting with knees held in flexed posture.
Key exclusion criteria (7 listed)
- Are currently, or have previously, participated in any other forms of treatment for their knee pain.
- Significant articular or periarticular effusion or bursitis.
- Significant joint line tenderness.
- Intra-articular ligamentous instability.
- Patellar apprehension.
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 |
|---|---|---|
| Knee abduction moment-reducing footwearPatients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention. | Device | Control footwear, Knee abduction moment-reducing footwear |
Primary outcome
Knee joint internal abduction moments of force during running at 4m/s
Time frame: First day of joining the study
Motion analysis trials will be conducted on each subject with both the control and intervention footwear. Inverse dynamics calculations will reveal the internal joint loading for each subject. Knee joint moments will be compared within subjects for each footwear condition.
1 secondary outcome
Change in subjective levels of perceived knee pain over six weeks
Time frame: Upon initial recruitment to the study, and once per week for six weeks thereafter
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 Feb 2014.
- Derived from this study: PubMed 26230399Lewinson RT, Wiley JP, Humble RN, Worobets JT, Stefanyshyn DJ. Altering Knee Abduction Angular Impulse Using Wedged Insoles for Treatment of Patellofemoral Pain in Runners: A Six-Week Randomized Controlled Trial. PLoS One. 2015 Jul 31;10(7):e0134461. doi: 10.1371/journal.pone.0134461. eCollection 2015.
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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.
Darren J. Stefanyshyn, Ph.D. P.Eng. principal investigator
University of Calgary
Ryan T. Lewinson, B.Sc. principal investigator
University of Calgary
Jay T. Worobets, Ph.D. principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Knee abduction moment-reducing footwear in people with Patellofemoral Pain Syndrome, run by University of Calgary at 1 site in Canada.
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 8 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 Feb 2014. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Knee joint internal abduction moments of force during running at 4m/s (time frame: First day of joining the study). 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 NCT01332110, which also lists 1 linked publication.
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 Feb 2014.