Strength Training in Female Runners With Patellofemoral Pain
Primary Purpose
Patellofemoral Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Training (BFRT)
Sham Blood Flow Restriction Training (Sham BFRT)
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Syndrome focused on measuring Blood Flow Restriction, Running, Patellofemoral Pain
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
BFRT Group
Standard of Care Group
Arm Description
This group will receive physical therapy plus active BFRT.
This group will receive physical therapy plus sham BFRT.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04480528
First Posted
July 16, 2020
Last Updated
March 3, 2022
Sponsor
Lauren Erickson
Collaborators
American College of Sports Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04480528
Brief Title
Strength Training in Female Runners With Patellofemoral Pain
Official Title
The Effect of Various Strength Training Protocols in Female Runners With Patellofemoral Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
November 13, 2021 (Actual)
Study Completion Date
November 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lauren Erickson
Collaborators
American College of Sports Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Syndrome
Keywords
Blood Flow Restriction, Running, Patellofemoral Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BFRT Group
Arm Type
Experimental
Arm Description
This group will receive physical therapy plus active BFRT.
Arm Title
Standard of Care Group
Arm Type
Sham Comparator
Arm Description
This group will receive physical therapy plus sham BFRT.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Training (BFRT)
Intervention Description
A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.
Intervention Type
Other
Intervention Name(s)
Sham Blood Flow Restriction Training (Sham BFRT)
Intervention Description
A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.
Primary Outcome Measure Information:
Title
Change in Isometric Quadriceps Strength
Description
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.
Time Frame
10 weeks
Title
Change in Isokinetic Quadriceps Strength
Description
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.
Time Frame
10 weeks
Title
Change in Isometric Hip Abduction Strength
Description
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.
Time Frame
10 weeks
Title
Change in Isometric Hip Extension Strength
Description
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.
Time Frame
10 weeks
Title
Change in Isometric Hip External Rotation Strength
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in Hip Adduction Angle
Description
Change in peak hip adduction angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Time Frame
10 weeks
Title
Change in Hip Internal Rotation Angle
Description
Change in peak hip internal rotation angle will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Time Frame
10 weeks
Title
Change in Peak Knee Extensor Moment
Description
Change in peak knee extensor moment will be measured via a three-dimensional running gait analysis on an instrumented treadmill.
Time Frame
10 weeks
Title
Change in Pain: Brief Pain Inventory (BPI)
Description
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.
Time Frame
10 weeks
Title
Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
10 weeks
Title
Change in Knee Function
Description
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.
Time Frame
10 weeks
Title
Change in Running Ability
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Erickson, DPT
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Strength Training in Female Runners With Patellofemoral Pain
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