Strength Training in Female Runners With Patellofemoral Pain

NCT ID: NCT04480528

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2021-11-13

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.

Conditions

Patellofemoral Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BFRT Group

This group will receive physical therapy plus active BFRT.

Group Type: EXPERIMENTAL

Blood Flow Restriction Training (BFRT)

Intervention Type: OTHER

A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.

Standard of Care Group

This group will receive physical therapy plus sham BFRT.

Group Type: SHAM_COMPARATOR

Sham Blood Flow Restriction Training (Sham BFRT)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American College of Sports Medicine

OTHER

Sponsor Role: collaborator

Lauren Erickson

OTHER

Sponsor Role: lead

Responsible Party

Lauren Erickson

Graduate Research Assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lauren Erickson, DPT

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

54348

Identifier Type: -

Identifier Source: org_study_id