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Clinical Trials/NCT05403944
NCT05403944
Active, not recruiting
Not Applicable

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

University of Connecticut3 sites in 1 country88 target enrollmentOctober 13, 2022

Overview

Phase
Not Applicable
Intervention
Standard of Care Rehabilitation (SOC)
Conditions
Patellofemoral Pain
Sponsor
University of Connecticut
Enrollment
88
Locations
3
Primary Endpoint
Change in knee pain.
Status
Active, not recruiting
Last Updated
15 days ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 13, 2022
End Date
September 1, 2027
Last Updated
15 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Neal Glaviano

Responsible Party

University of Connecticut

Eligibility Criteria

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.

Arms & Interventions

Standard of Care (SOC)

The SOC rehabilitation group will complete three strength sessions a week. All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles. The load magnitude for exercises will be between 60-70% of their 1 repetition max (1RM), with 3 sets of 12 repetitions and a 2-3-minute rest between sets. Time under tension will be prescribed as slow to moderate, with a 2-second concentric phase and 2-second eccentric phase for each exercise. Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.

Intervention: Standard of Care Rehabilitation (SOC)

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Those in the STRIPE group will complete two power and one strength training sessions a week. All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles. The load magnitude will be greater than 60% of the 1RM, with the goal of continually loading against heavy resistance. Participants will complete 4 sets of 6 repetitions, with 3-5 minutes of rest between sets. Time under tension will be prescribed as \<1 second for the concentric phase and 1 second for the eccentric phase of the exercise. The strength training sessions will adhere to same parameters as the SOC. Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.

Intervention: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Outcomes

Primary Outcomes

Change in knee pain.

Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

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.

Change in self-reported knee function.

Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

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.

Patellofemoral pain recurrence

Time Frame: 6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention

The number of patients who report symptoms of patellofemoral pain

Change in pelvic drop during a single leg squat

Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

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.

Change in hip rate of torque development

Time Frame: Immediately after the intervention.

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.

Change in hip adduction during a single leg squat

Time Frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

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.

Secondary Outcomes

  • Change in psychological factors(Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.)
  • Change in cognitive factors(Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.)
  • Change in coping strategy(Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.)
  • Change in physical activity(Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.)
  • Change in self-reported knee function(Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.)

Study Sites (3)

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