Patellofemoral SyndromeNCT04480528
Strength Training in Female Runners With Patellofemoral Pain
A study testing Blood Flow Restriction Training (BFRT) in people with Patellofemoral Syndrome, run by Lauren Erickson at 1 site in United States.
Trial summary
Patellofemoral pain (PFP) is a common running-related injury that is often referred to as runner's knee. The condition typically presents with pain in the front of the knee that is located around or behind the knee cap. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Patellofemoral Syndrome
- What is being tested?
- Blood Flow Restriction Training (BFRT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 13 Nov 2021
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pain around (peripatellar) or behind (retropatellar) the patella, which is aggravated by running and at least one other activity that loads the patellofemoral joint during weight bearing on a flexed knee such as kneeling, squatting, stair ambulation, and jumping/hopping
- Insidious onset of symptoms unrelated to trauma
- Pain present for at least 2 months
- Pain rating of at least 3/10 on the visual analog scale during running
- Report running at least 10 miles per week currently or just prior to onset of injury
- Score a maximum of 85% on either the Knee Outcome Survey Activities of Daily Living Scale or Sports Activity Scale (KOS-ADL or KOS-SAS)
Who cannot join
- Knee pain resulting from acute trauma
- Concurrent ligamentous instability, meniscus pathology, patellar or iliotibial band tendinopathy
- History of patellar dislocations or instability, or previous reconstructive surgery to the knee
- Other lower extremity or lower back injury within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Various Strength Training Protocols in Female Runners With Patellofemoral Pain
Patellofemoral pain (PFP) is a common running-related injury that is often referred to as runner's knee. The condition typically presents with pain in the front of the knee that is located around or behind the knee cap. This injury occurs twice as frequently in females and is often associated with weakness of the muscles of the thigh and hip, as well as altered running form. Heavy-weight strength training is needed in order to improve muscle weakness; however, this puts a significant amount of load on the knee joint and it is difficult for individuals with PFP to train at this level without experiencing increased pain and joint discomfort. Blood flow restriction training (BFRT) is a promising alternative method to safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized band is applied to the thigh in order to partially restrict blood flow as a patient exercises in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the muscle combined with strength training creates an environment within the muscle that results in the ability of low-weight strength training to provide the same results as heavy-weight strength training.
This study will evaluate how low-weight strength training with and without BFRT affects thigh and hip strength, and consequently pain, function, running ability, and running form in female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function, improved running ability, and improved running form compared to low-weight strength training without BFRT. The expected results will have a significant impact within the running community by providing a safe and effective treatment that increases strength and improves running form while reducing pain and joint loading. This will also have an impact on the larger field of sports medicine by providing an alternative method to improve strength, as well as improve function when heavy-weight strength training is not well tolerated or unsafe due to injury.
- Conditions
- Patellofemoral Syndrome
- Being tested
- Blood Flow Restriction Training (BFRT), Sham Blood Flow Restriction Training (Sham BFRT)
- Keywords
- Blood Flow Restriction, Running, Patellofemoral 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.
Blood Flow Restriction Training (BFRT)Other
A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.
Sham Blood Flow Restriction Training (Sham BFRT)Other
A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.
| Study group | Role | What they receive |
|---|---|---|
| BFRT Group | Experimental | This group will receive physical therapy plus active BFRT. Receives: Other: Blood Flow Restriction Training (BFRT) |
| Standard of Care Group | Sham comparator | This group will receive physical therapy plus sham BFRT. Receives: Other: Sham Blood Flow Restriction Training (Sham BFRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Isometric Quadriceps Strength
The subject will be seated in a Biodex 4 dynamometer with their knee locked at 90 degrees of flexion. The subject will be asked to kick into the dynamometer pad as hard as they can and the peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
Measured: 10 weeks
Change in Isokinetic Quadriceps Strength
The subject will be seated in a Biodex 4 dynamometer and be asked to kick back-and-forth into the dynamometer pad as hard and as fast as they can. The peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
Measured: 10 weeks
Change in Isometric Hip Abduction Strength
The subject will be lying in the side-lying position with a stabilizing strap placed around the thigh. The subject will be asked to press out as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip abduction strength.
Measured: 10 weeks
Change in Isometric Hip Extension Strength
The subject will be lying on their stomach with their knee flexed to 90 degrees and a stabilizing strap placed around the thigh. The subject will be asked to press up as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip extension strength.
Measured: 10 weeks
Change in Isometric Hip External Rotation Strength
The subject will be seated with their knee flexed to 90 degrees and a stabilizing strap placed around the lower leg. The subject will be asked to press inward as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip external rotation strength.
Measured: 10 weeks
Secondary outcomes (7)
Change in Hip Adduction Angle
Change in peak hip adduction angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Measured: 10 weeks
Change in Hip Internal Rotation Angle
Change in peak hip internal rotation angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Measured: 10 weeks
Change in Peak Knee Extensor Moment
Change in peak knee extensor moment will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Measured: 10 weeks
Change in Pain: Brief Pain Inventory (BPI)
Pain will be measured using the Brief Pain Inventory (BPI), which assesses pain (least, most, average, and present pain) on a scale from 0-10. Lower numbers indicate less pain while higher numbers indicate more pain.
Measured: 10 weeks
Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score
Patellofemoral pain will be measured using the Knee Injury and Osteoarthritis Outcome Score - Patellofemoral Pain. It is an 11-item questionnaire and items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee patellofemoral pain while higher numbers indicate less patellofemoral pain.
Measured: 10 weeks
Change in Knee Function
Knee function will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains 5 subscales: Pain - 9 items, other Symptoms - 7 items, Function in daily living (ADL) - 17 items, Function in Sport and Recreation (Sport/Rec) - 5 items, and knee-related Quality of Life (QoL) - 4 items. Items are coded from 0 to 4, no problems to extreme problems. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate greater knee problems while higher numbers indicate less knee problems.
Measured: 10 weeks
Change in Running Ability
Running ability will be measured using the University of Wisconsin Running Injury and Recovery Index (UWRI). It is a 9-item questionnaire and items are coded from 0 to 4, lower scores indicating an inability to run and higher scores indicating no pain/issue with running. Scores are transformed to a 0-100 scale and represent the percentage of total possible score achieved. Lower numbers indicate limited running ability while higher numbers indicate full running ability.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start8 Jun 2020
- Primary completion13 Nov 2021
- Study completion13 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauren Erickson
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor-investigator, Lauren Erickson, University of Kentucky
- Investigators
- Lauren Erickson, DPT, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480528
- Sponsor's protocol ID
- 54348
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Various Strength Training Protocols in Female Runners With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT04480528
- Acronym / sponsor ID
- 54348
- Conditions
- Patellofemoral Syndrome
- Keywords
- Blood Flow Restriction, Running, Patellofemoral Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lauren EricksonUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 13 Nov 2021 (actual)
- Study completion
- 13 Nov 2021 (actual)
- First posted
- 21 Jul 2020 (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.
Patellofemoral pain (PFP) is a common running-related injury that is often referred to as runner's knee. The condition typically presents with pain in the front of the knee that is located around or behind the knee cap. This injury occurs twice as frequently in females and is often associated with weakness of the muscles of the thigh and hip, as well as altered running form. Heavy-weight strength training is needed in order to improve muscle weakness; however, this puts a significant amount of load on the knee joint and it is difficult for individuals with PFP to train at this level without experiencing increased pain and joint discomfort. Blood flow restriction training (BFRT) is a promising alternative method to safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized band is applied to the thigh in order to partially restrict blood flow as a patient exercises in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the muscle combined with strength training creates an environment within the muscle that results in the ability of low-weight strength training to provide the same results as heavy-weight strength training.
This study will evaluate how low-weight strength training with and without BFRT affects thigh and hip strength, and consequently pain, function, running ability, and running form in female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function, improved running ability, and improved running form compared to low-weight strength training without BFRT. The expected results will have a significant impact within the running community by providing a safe and effective treatment that increases strength and improves running form while reducing pain and joint loading. This will also have an impact on the larger field of sports medicine by providing an alternative method to improve strength, as well as improve function when heavy-weight strength training is not well tolerated or unsafe due to injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFRT Group | Experimental | Other: Blood Flow Restriction Training (BFRT)This group will receive physical therapy plus active BFRT. |
| Standard of Care Group | Sham comparator | Other: Sham Blood Flow Restriction Training (Sham BFRT)This group will receive physical therapy plus sham BFRT. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pain around (peripatellar) or behind (retropatellar) the patella, which is aggravated by running and at least one other activity that loads the patellofemoral joint during weight bearing on a flexed knee such as kneeling, squatting, stair ambulation, and jumping/hopping
- Insidious onset of symptoms unrelated to trauma
- Pain present for at least 2 months
- Pain rating of at least 3/10 on the visual analog scale during running
- Report running at least 10 miles per week currently or just prior to onset of injury
Key exclusion criteria (4 listed)
- Knee pain resulting from acute trauma
- Concurrent ligamentous instability, meniscus pathology, patellar or iliotibial band tendinopathy
- History of patellar dislocations or instability, or previous reconstructive surgery to the knee
- Other lower extremity or lower back injury within the past 6 months
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 |
|---|---|---|
| Blood Flow Restriction Training (BFRT)A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises. | Other | BFRT Group |
| Sham Blood Flow Restriction Training (Sham BFRT)A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises. | Other | Standard of Care Group |
Primary outcome
Change in Isometric Quadriceps Strength
Time frame: 10 weeks
The subject will be seated in a Biodex 4 dynamometer with their knee locked at 90 degrees of flexion. The subject will be asked to kick into the dynamometer pad as hard as they can and the peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
Change in Isokinetic Quadriceps Strength
Time frame: 10 weeks
The subject will be seated in a Biodex 4 dynamometer and be asked to kick back-and-forth into the dynamometer pad as hard and as fast as they can. The peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.
Change in Isometric Hip Abduction Strength
Time frame: 10 weeks
The subject will be lying in the side-lying position with a stabilizing strap placed around the thigh. The subject will be asked to press out as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip abduction strength.
Change in Isometric Hip Extension Strength
Time frame: 10 weeks
The subject will be lying on their stomach with their knee flexed to 90 degrees and a stabilizing strap placed around the thigh. The subject will be asked to press up as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip extension strength.
Change in Isometric Hip External Rotation Strength
Time frame: 10 weeks
The subject will be seated with their knee flexed to 90 degrees and a stabilizing strap placed around the lower leg. The subject will be asked to press inward as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip external rotation strength.
7 secondary outcomes
Change in Hip Adduction Angle
Time frame: 10 weeks
Change in Hip Internal Rotation Angle
Time frame: 10 weeks
Change in Peak Knee Extensor Moment
Time frame: 10 weeks
Change in Pain: Brief Pain Inventory (BPI)
Time frame: 10 weeks
Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score
Time frame: 10 weeks
Change in Knee Function
Time frame: 10 weeks
Change in Running Ability
Time frame: 10 weeks
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 4 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Lauren Erickson, DPT principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training (BFRT) in people with Patellofemoral Syndrome, run by Lauren Erickson 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 6 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 4 Mar 2022. 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. 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.
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?
Change in Isometric Quadriceps Strength (time frame: 10 weeks). 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?
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 4 Mar 2022.