Patellofemoral Pain SyndromeNCT03067545
Do Simple Running Technique Changes Reduce Pain and Change Injury Causing Mechanics
A study testing Step rate increase in people with Patellofemoral Pain Syndrome and Medial Tibial Stress Syndrome, run by University of Salford at 1 site in United Kingdom.
Trial summary
This project aims to investigate whether an increase in step rate can be used to reduce pain and injury causing movement patterns in runners who are currently experiencing achilles tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Medial Tibial Stress Syndrome, Iliotibial Band Syndrome
- What is being tested?
- Step rate increase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2017to 1 Dec 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Runners presenting with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendonopathy. Diagnosis to be confirmed via a qualified physiotherapist present at all sessions
- Currently running at self reported less than normal training volume
- Pain reported to onset during running
- Provide written consent to participate
Who cannot join
- history of a traumatic onset of injury
- previous lower limb surgery
- currently not running due to pain
- cardiac or respiratory disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Salford Health Sciences
Salford, England, m6 6PU
About this study
Official title: Do Simple Running Technique Changes Reduce Pain and Change Injury Causing Mechanics in Runners With Common Running Related Injuries?
This project aims to investigate whether an increase in step rate can be used to reduce pain and injury causing movement patterns in runners who are currently experiencing achilles tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress syndrome.
Many injuries have been reported to share similar injury causing movement patterns. For example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be caused by increased side to side drop of the pelvis and inward movement of the hip.
Read more
Gait retraining is a method of changing the way people run in order to change movement patterns.Increasing step rate may present a gait retraining method that does not pose further injury risks and can be used across multiple different injury populations. Studies have shown increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the changes in movement patterns increasing step rate has been recommended as an intervention for the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an increase in step rate can reduce pain and change injury causing mechanics in runners currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendinopathy.
The aim of the project is to use a simple gait intervention, increasing step rate to investigate if this technique change can reduce pain immediately, at short term follow up and long term follow up. The project will also look at whether an increased step rate can be maintained at follow up and whether this changes movement patterns proposed to be the cause of injury.
Runners will be recruited from local running clubs and competitions using poster advertisement at running clubs and emailed to running clubs
Read the detailed description
All data will be collected at the university of Salford podiatry clinic gait laboratory. Participants will be recruited from running clubs and races via poster advertisement sent via email to the running club and on advertisement at the club. Also participants presenting at the running performance clinic with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome and achilles tendonopathy will be invited to take part in the research study investigating the effects of gait retraining on injury. Participants who agree to take part will be sent an email confirming their appointment along with an information sheet detailing the study which they are encouraged to read before attending the appointment. They will have contact details of the lead researcher should they wish to ask any further questions
The objectives above will be addressed via the following data collection procedure:
On arriving at the running clinic participants will be informed that the gait retraining intervention aims to reduce pain when running and that there is a risk that the retraining protocol will not affect their pain. If there are no improvements to symptoms following gait retraining they will be then directed to the appropriate medical service for further management. Participants will be informed as to the procedures and given the chance to read through an information sheet again detailing the procedures involve. If on reading the information sheet participants do not wish to take part they can terminate the appointment at any time. Before data collection begins participants will sign a consent form, a running history form and a health screening questionnaire will be completed by a qualified physiotherapist in order to assess the patients suitability to complete the assessment with no further risk to their health.
Procedures:
Participants will attend two visits 4 weeks apart. The first visit will consist of an initial assessment data collection and a retraining session. Detailed below. The second visit will consist of the same procedures in the initial assessment.
Initial Assessment data collection:
Participants will complete the appropriate self reported outcome measure: if iliotibial band syndrome or patellofemoral pain syndrome they will complete the Lower extremity Functional Index and the Anterior Knee Pain Scale. If they present with medial tibial stress syndrome they will complete the medial tibial stress syndrome score and the Lower Extremity Functional Index. If they present with achilles tendonopathy they will complete the VISA - A score and the Lower Extremity Functional Index.
Before running retroreflective markers will be attached to the subject on specific points of their body: shoe, ankle joint, knee joint, greater trochanter of the hip, thigh, lower leg, pelvis (anterior superior iliac spine, posterior superior iliac spine, iliac crest), lumbar spine, thoracic spine, sternum and acromion process off the shoulders. This marker placement is according to a protocol previously established and validated in a project undertaken at the University of Salford. A qualysis motion capture system will then be used to track the movement of these markers as the participant runs on a treadmill. Once the marker data has been collected then we will use custom software to calculate the kinematic (joint movement) patterns for each person.
Participants are required to run on a treadmill at two different speeds (3.2, 3.8m/s). These speeds have been chosen based on running speeds used in previous research to allow comparability between studies. If participants feel they are unable to run at these speeds they can run at a self selected running speed.
They will be given a 6 minute accommodation period running on the treadmill at 3.2m/s. At this point data will then be collected for 1 minute of running in order to gain data for ten steps of running for the right and left feet. Speed will then be increased to 3.8m/s where they will be given a 1 minute accommodation period with data collected for a further minute of running.
A qualified physiotherapists will monitor the patients feels ok to continue at each 2 minute interval. At the end of data collection for each running speed the participant will be asked to rate their current level of pain on a scale of 0 = no pain to 10 = sever pain. If at any point the participants pain exceeds 8 out of 10 or the participant feels they can no longer continue running the data collection will be terminated.
Steps will be identified when the foot markers are in contact with the treadmill, once ten steps have been collected the data will be averaged across all trials for right and left feet. During the data collection injured participants will be asked to rate their current level of pain while running using a numerical rating scale 0 = no pain and 10 = sever pain.
Retraining Session:
Once data has been collected participants will then be asked to run for a further 5 minutes at each speed under an increased step rate condition with data collected for the final 1 minute of the trial. Step rate will be calculated as number of steps per minute. Step rate will then be increased by 10% and participants instructed to run to an audible metronome to ensure the step rate increase is achieved. Again at the end of each running speed participants will be asked to rate their current level of pain using a numerical rating scale.
Following data collection participants will be permitted up to a further 15 minute practise session running to maintain the increase in step rate without the metronome present to allow participants to adjust to the new running technique.
Participants will then be instructed to continue their current level of running using the new running technique. Participants will have contact details to the lead researcher (email and phone number) and will be requested to provide weekly updates regarding their running and if any pain is experienced. This will ensure patients are continuing to improve, not running with an increase in pain and are able to ask any questions they may have. If patient's symptoms are increasing they will be informed to stop running and terminated from the assessment and directed to the appropriate medical professional for further assessment.
Participants will be reassessed between 3 weeks and 5 weeks later following the same procedures outlined in the initial assessment data collection as well as at a 3 month follow up following the same procedures to investigate long term improvement.
- Conditions
- Patellofemoral Pain Syndrome, Medial Tibial Stress Syndrome, Iliotibial Band Syndrome, Achilles Tendinopathy
- Being tested
- Step rate increase
- Medical subject headings
- Patellofemoral Pain Syndrome, Medial Tibial Stress Syndrome, Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step rate increaseOther
increase the step rate during running by 10% steps per minute
| Study group | Role | What they receive |
|---|---|---|
| step rate increase | Experimental | increase in running stride rate by 10% Receives: Other: Step rate increase |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinematic data (lower limb joint angles during running)
lower limb joint angles during running
Measured: change from immediate, 4 weeks & 3 months
lower extremity functional scale
patient reported outcome measure of lower limb pain symptoms
Measured: change from 4 weeks & 3 months
anterior knee pain scale
patient reported outcome measure of lower limb pain symptoms
Measured: change from 4 weeks & 3 months
medial tibial stress syndrome score
patient reported outcome measure of lower limb pain symptoms
Measured: change from 4 weeks & 3 months
numerical rating scale
pain rating scale for pain experienced during running
Measured: change from 4 weeks & 3 months
Secondary outcomes (1)
questionnaire measure of self reported running distance
questionnaire measure of the total pain free distance the patient is able to run
Measured: change from 4 weeks & 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start22 Mar 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- single subject repeated measures design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Bramah, University of Salford
- Investigators
- Chris Bramah, MSc, Principal investigator, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067545
- Sponsor's protocol ID
- HSCR 16-49
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bramah C, Preece SJ, Gill N, Herrington L. A 10% Increase in Step Rate Improves Running Kinematics and Clinical Outcomes in Runners With Patellofemoral Pain at 4 Weeks and 3 Months. Am J Sports Med. 2019 Dec;47(14):3406-3413. doi: 10.1177/0363546519879693. Epub 2019 Oct 28.
PubMed 31657964
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Simple Running Technique Changes Reduce Pain and Change Injury Causing Mechanics in Runners With Common Running Related Injuries?
- ClinicalTrials.gov ID
- NCT03067545
- Acronym / sponsor ID
- HSCR 16-49
- Conditions
- Patellofemoral Pain Syndrome, Medial Tibial Stress Syndrome, Iliotibial Band Syndrome, Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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.
This project aims to investigate whether an increase in step rate can be used to reduce pain and injury causing movement patterns in runners who are currently experiencing achilles tendonopathy, iliotibial band syndrome, patellofemoral pain syndrome and medial tibial stress syndrome.
Many injuries have been reported to share similar injury causing movement patterns. For example iliotibial band syndrome and patellofemoral pain syndrome have been reported to be caused by increased side to side drop of the pelvis and inward movement of the hip.
Gait retraining is a method of changing the way people run in order to change movement patterns.Increasing step rate may present a gait retraining method that does not pose further injury risks and can be used across multiple different injury populations. Studies have shown increasing step rate can reduce frontal plane movement patterns at the pelvis, hip and foot as well as reducing sagittal plane joint angles such as ankle dorsiflexion. Based on the changes in movement patterns increasing step rate has been recommended as an intervention for the treatment of patellofemoral pain syndrome, medial tibial stress syndrome, iliotibial band syndrome and achilles tendonopathy. Therefore this study aims to investigate whether an increase in step rate can reduce pain and change injury causing mechanics in runners currently running with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendinopathy.
The aim of the project is to use a simple gait intervention, increasing step rate to investigate if this technique change can reduce pain immediately, at short term follow up and long term follow up. The project will also look at whether an increased step rate can be maintained at follow up and whether this changes movement patterns proposed to be the cause of injury.
Runners will be recruited from local running clubs and competitions using poster advertisement at running clubs and emailed to running clubs
Detailed description
All data will be collected at the university of Salford podiatry clinic gait laboratory. Participants will be recruited from running clubs and races via poster advertisement sent via email to the running club and on advertisement at the club. Also participants presenting at the running performance clinic with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome and achilles tendonopathy will be invited to take part in the research study investigating the effects of gait retraining on injury. Participants who agree to take part will be sent an email confirming their appointment along with an information sheet detailing the study which they are encouraged to read before attending the appointment. They will have contact details of the lead researcher should they wish to ask any further questions
The objectives above will be addressed via the following data collection procedure:
On arriving at the running clinic participants will be informed that the gait retraining intervention aims to reduce pain when running and that there is a risk that the retraining protocol will not affect their pain. If there are no improvements to symptoms following gait retraining they will be then directed to the appropriate medical service for further management. Participants will be informed as to the procedures and given the chance to read through an information sheet again detailing the procedures involve. If on reading the information sheet participants do not wish to take part they can terminate the appointment at any time. Before data collection begins participants will sign a consent form, a running history form and a health screening questionnaire will be completed by a qualified physiotherapist in order to assess the patients suitability to complete the assessment with no further risk to their health.
Procedures:
Participants will attend two visits 4 weeks apart. The first visit will consist of an initial assessment data collection and a retraining session. Detailed below. The second visit will consist of the same procedures in the initial assessment.
Initial Assessment data collection:
Participants will complete the appropriate self reported outcome measure: if iliotibial band syndrome or patellofemoral pain syndrome they will complete the Lower extremity Functional Index and the Anterior Knee Pain Scale. If they present with medial tibial stress syndrome they will complete the medial tibial stress syndrome score and the Lower Extremity Functional Index. If they present with achilles tendonopathy they will complete the VISA - A score and the Lower Extremity Functional Index.
Before running retroreflective markers will be attached to the subject on specific points of their body: shoe, ankle joint, knee joint, greater trochanter of the hip, thigh, lower leg, pelvis (anterior superior iliac spine, posterior superior iliac spine, iliac crest), lumbar spine, thoracic spine, sternum and acromion process off the shoulders. This marker placement is according to a protocol previously established and validated in a project undertaken at the University of Salford. A qualysis motion capture system will then be used to track the movement of these markers as the participant runs on a treadmill. Once the marker data has been collected then we will use custom software to calculate the kinematic (joint movement) patterns for each person.
Participants are required to run on a treadmill at two different speeds (3.2, 3.8m/s). These speeds have been chosen based on running speeds used in previous research to allow comparability between studies. If participants feel they are unable to run at these speeds they can run at a self selected running speed.
They will be given a 6 minute accommodation period running on the treadmill at 3.2m/s. At this point data will then be collected for 1 minute of running in order to gain data for ten steps of running for the right and left feet. Speed will then be increased to 3.8m/s where they will be given a 1 minute accommodation period with data collected for a further minute of running.
A qualified physiotherapists will monitor the patients feels ok to continue at each 2 minute interval. At the end of data collection for each running speed the participant will be asked to rate their current level of pain on a scale of 0 = no pain to 10 = sever pain. If at any point the participants pain exceeds 8 out of 10 or the participant feels they can no longer continue running the data collection will be terminated.
Steps will be identified when the foot markers are in contact with the treadmill, once ten steps have been collected the data will be averaged across all trials for right and left feet. During the data collection injured participants will be asked to rate their current level of pain while running using a numerical rating scale 0 = no pain and 10 = sever pain.
Retraining Session:
Once data has been collected participants will then be asked to run for a further 5 minutes at each speed under an increased step rate condition with data collected for the final 1 minute of the trial. Step rate will be calculated as number of steps per minute. Step rate will then be increased by 10% and participants instructed to run to an audible metronome to ensure the step rate increase is achieved. Again at the end of each running speed participants will be asked to rate their current level of pain using a numerical rating scale.
Following data collection participants will be permitted up to a further 15 minute practise session running to maintain the increase in step rate without the metronome present to allow participants to adjust to the new running technique.
Participants will then be instructed to continue their current level of running using the new running technique. Participants will have contact details to the lead researcher (email and phone number) and will be requested to provide weekly updates regarding their running and if any pain is experienced. This will ensure patients are continuing to improve, not running with an increase in pain and are able to ask any questions they may have. If patient's symptoms are increasing they will be informed to stop running and terminated from the assessment and directed to the appropriate medical professional for further assessment.
Participants will be reassessed between 3 weeks and 5 weeks later following the same procedures outlined in the initial assessment data collection as well as at a 3 month follow up following the same procedures to investigate long term improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single subject repeated measures design
| Arm | Type | Receives |
|---|---|---|
| step rate increase | Experimental | Other: Step rate increaseincrease in running stride rate by 10% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Runners presenting with patellofemoral pain syndrome, iliotibial band syndrome, medial tibial stress syndrome or achilles tendonopathy. Diagnosis to be confirmed via a qualified physiotherapist present at all sessions
- Currently running at self reported less than normal training volume
- Pain reported to onset during running
- Provide written consent to participate
Key exclusion criteria (4 listed)
- history of a traumatic onset of injury
- previous lower limb surgery
- currently not running due to pain
- cardiac or respiratory disease
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 |
|---|---|---|
| Step rate increaseincrease the step rate during running by 10% steps per minute | Other | step rate increase |
Primary outcome
kinematic data (lower limb joint angles during running)
Time frame: change from immediate, 4 weeks & 3 months
lower limb joint angles during running
lower extremity functional scale
Time frame: change from 4 weeks & 3 months
patient reported outcome measure of lower limb pain symptoms
anterior knee pain scale
Time frame: change from 4 weeks & 3 months
patient reported outcome measure of lower limb pain symptoms
medial tibial stress syndrome score
Time frame: change from 4 weeks & 3 months
patient reported outcome measure of lower limb pain symptoms
numerical rating scale
Time frame: change from 4 weeks & 3 months
pain rating scale for pain experienced during running
1 secondary outcome
questionnaire measure of self reported running distance
Time frame: change from 4 weeks & 3 months
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 28 Feb 2019.
- Derived from this study: PubMed 31657964Bramah C, Preece SJ, Gill N, Herrington L. A 10% Increase in Step Rate Improves Running Kinematics and Clinical Outcomes in Runners With Patellofemoral Pain at 4 Weeks and 3 Months. Am J Sports Med. 2019 Dec;47(14):3406-3413. doi: 10.1177/0363546519879693. Epub 2019 Oct 28.
- Individual participant dataSharing planned: No
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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.
Chris Bramah, MSc principal investigator
University of Salford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step rate increase in people with Patellofemoral Pain Syndrome and Medial Tibial Stress Syndrome, run by University of Salford at 1 site in United Kingdom.
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 4 inclusion and 4 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 28 Feb 2019. 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 Kingdom. 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 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?
kinematic data (lower limb joint angles during running) (time frame: change from immediate, 4 weeks & 3 months). 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 NCT03067545, 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 28 Feb 2019.