Patellofemoral Pain SyndromeNCT02567123
Running Study for Runners With Chronic Knee Pain
A study testing Experimental in people with Patellofemoral Pain Syndrome, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related… Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to May 2015
- Phase
- Interventional
- 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 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of patellofemoral pain
- No history of any cardiovascular issues.
- Currently running as part of training program
Who cannot join
- No patellofemoral pain present.
- Not currently running as part of training program
- Other lower extremity pain and/or injury that interferes with ability to run.
- Pregnant
- Not in the selected age ranges
- Presence of cardiovascular or cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: The Effects of Gait Retraining in Runners With Patellofemoral Pain: A Randomized Trial
The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related patellofemoral knee pain.
Read the detailed description
Runners will come to the Gait Analysis Lab on north campus of the University of New Mexico, HSSB 168, for the first running trial. During this time you will fill out a health questionnaire, receive an assessment by a physical therapist, and be given a new pair of running shoes to use for the duration of the study.
Runners will be equipped with several reflective markers, which will be placed on your lower body. Runners will then complete several passes across a runway while we record your running with a motion analysis system. Runners will be equipped with a mouthpiece and nose clip. You will run for 10 minutes while we collect the gases you breathe.Twenty-four hours after you complete this running trial, you will come to our Exercise Physiology lab in Johnson Center, B143 to perform the training sessions. During this time you will run for about 10-30 minutes in front of a mirror and receive feedback from the research team. You will perform these training sessions eight times over two weeks. Twenty-four hours after your last training session, you will perform another follow-up running trial, which will be the same as the first trial. After completing the second running trial, you will be allowed to return to your normal running routine for about one month. After one month, you will return to the Gait Analysis lab to perform a final running trial, which will be the same as the first and second running trials.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Experimental
- 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.
ExperimentalBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Runners are switched from a rearfoot strike running pattern to a forefoot strike running pattern. Receives: Behavioral: Experimental |
| Control | No intervention | Runners continue to use their normal rearfoot strike running pattern with no intervention in place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 6 weeks
Secondary outcomes (8)
Knee abduction
Measured: 6 weeks
Knee range of motion
Measured: 6 weeks
ankle flexion
Measured: 6 weeks
ankle range of motion
Measured: 6 weeks
Knee flexion
Measured: 6 weeks
Patellofemoral Stress
Measured: 6 weeks
Patellofemoral contact force
Measured: 6 weeks
Achilles tendon force
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Not Applicable Clinical Trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine M Mermier, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567123
- Sponsor's protocol ID
- UNM-17714
- Status last verified
- Mar 2024
- First submitted
- 30 Sep 2015
- Last updated
- 12 Mar 2024
- Results posted
- No
Publications
Relph N, Greaves H, Armstrong R, Prior TD, Spencer S, Griffiths IB, Dey P, Langley B. Running shoes for preventing lower limb running injuries in adults. Cochrane Database Syst Rev. 2022 Aug 22;8(8):CD013368. doi: 10.1002/14651858.CD013368.pub2.
PubMed 35993829Roper JL, Harding EM, Doerfler D, Dexter JG, Kravitz L, Dufek JS, Mermier CM. The effects of gait retraining in runners with patellofemoral pain: A randomized trial. Clin Biomech (Bristol). 2016 Jun;35:14-22. doi: 10.1016/j.clinbiomech.2016.03.010. Epub 2016 Apr 7.
PubMed 27111879
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gait Retraining in Runners With Patellofemoral Pain: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02567123
- Acronym / sponsor ID
- UNM-17714
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not Applicable Clinical Trial.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Oct 2015 (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.
The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related patellofemoral knee pain.
Detailed description
Runners will come to the Gait Analysis Lab on north campus of the University of New Mexico, HSSB 168, for the first running trial. During this time you will fill out a health questionnaire, receive an assessment by a physical therapist, and be given a new pair of running shoes to use for the duration of the study.
Runners will be equipped with several reflective markers, which will be placed on your lower body. Runners will then complete several passes across a runway while we record your running with a motion analysis system. Runners will be equipped with a mouthpiece and nose clip. You will run for 10 minutes while we collect the gases you breathe.Twenty-four hours after you complete this running trial, you will come to our Exercise Physiology lab in Johnson Center, B143 to perform the training sessions. During this time you will run for about 10-30 minutes in front of a mirror and receive feedback from the research team. You will perform these training sessions eight times over two weeks. Twenty-four hours after your last training session, you will perform another follow-up running trial, which will be the same as the first trial. After completing the second running trial, you will be allowed to return to your normal running routine for about one month. After one month, you will return to the Gait Analysis lab to perform a final running trial, which will be the same as the first and second running trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ExperimentalRunners are switched from a rearfoot strike running pattern to a forefoot strike running pattern. |
| Control | No intervention | –Runners continue to use their normal rearfoot strike running pattern with no intervention in place. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of patellofemoral pain
- No history of any cardiovascular issues.
- Currently running as part of training program
Key exclusion criteria (6 listed)
- No patellofemoral pain present.
- Not currently running as part of training program
- Other lower extremity pain and/or injury that interferes with ability to run.
- Pregnant
- Not in the selected age ranges
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 |
|---|---|---|
| Experimental | Behavioural | Experimental |
Primary outcome
Pain
Time frame: 6 weeks
8 secondary outcomes
Knee abduction
Time frame: 6 weeks
Knee range of motion
Time frame: 6 weeks
ankle flexion
Time frame: 6 weeks
ankle range of motion
Time frame: 6 weeks
Knee flexion
Time frame: 6 weeks
Patellofemoral Stress
Time frame: 6 weeks
Patellofemoral contact force
Time frame: 6 weeks
Achilles tendon force
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Not Applicable Clinical Trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 35993829Relph N, Greaves H, Armstrong R, Prior TD, Spencer S, Griffiths IB, Dey P, Langley B. Running shoes for preventing lower limb running injuries in adults. Cochrane Database Syst Rev. 2022 Aug 22;8(8):CD013368. doi: 10.1002/14651858.CD013368.pub2.
- Derived from this study: PubMed 27111879Roper JL, Harding EM, Doerfler D, Dexter JG, Kravitz L, Dufek JS, Mermier CM. The effects of gait retraining in runners with patellofemoral pain: A randomized trial. Clin Biomech (Bristol). 2016 Jun;35:14-22. doi: 10.1016/j.clinbiomech.2016.03.010. Epub 2016 Apr 7.
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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.
Christine M Mermier, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Patellofemoral Pain Syndrome, run by University of New Mexico at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Not Applicable Clinical Trial.). Results are not available in the source record.
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?
Pain (time frame: 6 weeks). 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 NCT02567123, which also lists 2 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 12 Mar 2024.