Clinical trial NCT04480528: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Syndrome
Keywords: Blood Flow Restriction
Running
Patellofemoral Pain
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine
First posted: 2020-07-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Isometric Quadriceps Strength
timeFrame: 10 weeks
measure: Change in Isokinetic Quadriceps Strength
timeFrame: 10 weeks
measure: Change in Isometric Hip Abduction Strength
timeFrame: 10 weeks
measure: Change in Isometric Hip Extension Strength
timeFrame: 10 weeks
measure: Change in Isometric Hip External Rotation Strength
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Hip Adduction Angle
timeFrame: 10 weeks
measure: Change in Hip Internal Rotation Angle
timeFrame: 10 weeks
measure: Change in Peak Knee Extensor Moment
timeFrame: 10 weeks
measure: Change in Pain: Brief Pain Inventory (BPI)
timeFrame: 10 weeks
measure: Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 10 weeks
measure: Change in Knee Function
timeFrame: 10 weeks
measure: Change in Running Ability
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Lauren Erickson, DPT
role: PRINCIPAL_INVESTIGATOR
References: