Strength or Power Training for Patellofemoral Pain

Patellofemoral Pain Clinical Trial

— STRIPE  

Official title:

Optimizing Clinical Outcomes for Patients With Patellofemoral Pain Using Strength Training Rehabilitation Incorporating Power Exercises

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403944
• Other study ID #: HR22-0038
• Secondary ID: OR210126
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: University of Connecticut
• Contact: Neal Glaviano, PhD
• Phone: 8604866712
• Email: neal.glaviano[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension rate of torque development and single-leg squat kinematics). We hypothesize that participants with patellofemoral pain who complete the STRIPE program will have 1) decreased pain, 2) improved subjective function, 3) reduced patellofemoral pain recurrence rates, 4a) improved hip abduction/extension rate of torque development, and 4b) decreased hip adduction and pelvic drop during a single leg squat compared to participants who complete a SOC rehabilitation program.

Description:

The proposed study will compare strength-based exercises, which is the standard of care (SOC), that target the hip abductors, hip extensors, lumbo-pelvic, and quadriceps muscles, to a strength training program that utilized power-based exercises (Strength Training Rehabilitation Incorporating Power Exercises [STRIPE]). Individuals with patellofemoral pain, both within the military and general population, present with long-term pain, decreased subjective function, and high recurrence rates. Our primary outcomes are to determine intervention success with self-reported knee pain, measured by the visual analog scale, subjective function, measured by the anterior knee pain scale, and recurrence rates. Recent evidence suggests that two in every three individuals with patellofemoral pain report symptoms up to two years after seeking care, therefore we will assess patellofemoral pain recurrence rates for two years. Additionally, the proposed interventions target gluteal muscle function, supporting our selection of secondary outcome variables. We will assess rate of torque development, as power-based exercises are recommended to improve muscle capacity, of both the targeted gluteus medius and gluteus maximus. We will also assess frontal plane kinematics, as the gluteal muscles are responsible for controlling pelvic and hip motion during functional tasks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 2027
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participants to be between the ages of 18-40 years old.
• Insidious onset of symptoms greater than 3 months.
• Worst pain in the previous month of 3/10 with two of the following tasks: prolonged sitting, jumping, squatting, kneeling, running, and stair ambulation.

Exclusion Criteria:

• Other forms of anterior knee pain (Osgood-Schlatter, tendon pain, bursitis, etc.).
• History of lower extremity surgery.
• History of patella subluxation, meniscal injury or ligamentous instability.
• History of referred pain from the lumbar spine.

Related Conditions & MeSH terms

• Patellofemoral Pain
• Patellofemoral Pain Syndrome

Intervention

Behavioral:
• Standard of Care Rehabilitation (SOC)
6 weeks of standard of care rehabilitation will be given designed to target the core, hip, and quadriceps muscles. Each participant will be expected to complete 3 supervised telehealth sessions per week.
• Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
6 weeks of STRIPE rehabilitation will be given designed to target the core, hip, and quadriceps muscles. Each participant will be expected to complete 3 supervised telehealth sessions per week.

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida
United States	University of Connecticut	Storrs	Connecticut
United States	University of Toledo	Toledo	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	University of Central Florida, University of Toledo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in knee pain.	Data are presented as knee pain, assessed on the visual analog scale in centimeters, resulting in a score of 0-10, with 0 representing no pain and 10 being worst pain imaginable. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Primary	Change in self-reported knee function.	Data are presented as self-reported knee function, assessed by the anterior knee pain scale.; The scale ranged between 0-100, with 0 indicating complete disability and 100 indicating no disability. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Primary	Patellofemoral pain recurrence	The number of patients who report symptoms of patellofemoral pain	6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention
Primary	Change in hip rate of torque development	Hip abduction and extension rate of torque development will be assessed with a handheld dynamometer. Data are reported as linear, with higher scores representing a faster ability to develop hip muscle force. Group means and standard deviations will be reported.	Immediately after the intervention.
Primary	Change in hip adduction during a single leg squat	Data are presented as a degree, with a higher number representing a higher amount of hip adduction. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Primary	Change in pelvic drop during a single leg squat	Data are presented as a degree, with a higher number representing a higher amount of pelvic drop. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary	Change in psychological factors	Psychological factors will be measures with the PROMIS-10, a 10-item general self-reported questionnaire that assess general domains related to physical, mental, and social health, in addition to perceived quality of life. PROMIS-10 scores are standardized to the general population using a "T-Score", which is a score of 50 points and a standard deviation of 10-points. Higher scores on the PROMIS-10 indicate a healthier patient. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary	Change in cognitive factors	Cognitive factors will be assessed with the Fear-Avoidance Belief Questionnaire (FABQ), a dimension specific questionnaire. The FABQ contains two subscales - physical activity section that includes six-items, while the work section includes ten-items. The physical activity subscale score range between 0-24 and the work subscale is scored between 0-42. Higher scores identifying greater fear avoidance beliefs for both physical activity and work subscales. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary	Change in coping strategy	Coping strategies will be assessed with the Pain Self-Efficacy Questionnaire (PSEQ), a dimension specific questionnaire. The PSEQ is a ten-item, dimension specific questionnaire that assesses how confident participants are with performing activities while experiencing pain. Each item is rated on a scale ranging from 0 ("not at all confident") to 6 ("completely confident"). The PSEQ score ranges between 0-60, with a higher score representing higher confidence to function with pain. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary	Change in physical activity	Physical activity will be quantified with the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a dimension specific questionnaire. The IPAQ-SF is a 4-item short form that measures physical activity from the previous 7-days. Questions include the number of days per week the participant engaged in vigorous activities, moderate activities, walking, and sitting, with a follow-up question for each asking for duration of time for each task. Group means and standard deviations will be reported.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary	Change in self-reported knee function	The Knee Injury and Osteoarthritis Outcome Scale (KOOS) and the PFP subscale (KOOS-PF) will provide region and disease specific data throughout the study. The KOOS measures five separate dimensions; pain, symptoms, activities of daily living function, sports and recreational function, and quality of life. Each of the five domains are scored on a scale between 0-100, with lower scores representing greater impairments in self-reported function. The KOOS-PF subscale is an 11-item region specific questionnaire, ranging from 0-100, with greater scores also reflecting greater function.	Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.