search
Back to results

Strength or Power Training for Patellofemoral Pain (STRIPE)

Primary Purpose

Patellofemoral Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Rehabilitation (SOC)
Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of ConnecticutRecruiting
  • University of Central FloridaRecruiting
  • University of ToledoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care (SOC)

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Patellofemoral pain recurrence
The number of patients who report symptoms of patellofemoral pain
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 31, 2022
Last Updated
October 13, 2022
Sponsor
University of Connecticut
Collaborators
University of Central Florida, University of Toledo
search

1. Study Identification

Unique Protocol Identification Number
NCT05403944
Brief Title
Strength or Power Training for Patellofemoral Pain
Acronym
STRIPE
Official Title
Optimizing Clinical Outcomes for Patients With Patellofemoral Pain Using Strength Training Rehabilitation Incorporating Power Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
University of Central Florida, University of Toledo

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Standard of Care Rehabilitation (SOC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in knee pain.
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in self-reported knee function.
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Patellofemoral pain recurrence
Description
The number of patients who report symptoms of patellofemoral pain
Time Frame
6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention
Title
Change in hip rate of torque development
Description
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.
Time Frame
Immediately after the intervention.
Title
Change in hip adduction during a single leg squat
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in pelvic drop during a single leg squat
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Secondary Outcome Measure Information:
Title
Change in psychological factors
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in cognitive factors
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in coping strategy
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in physical activity
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.
Title
Change in self-reported knee function
Description
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.
Time Frame
Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neal Glaviano, PhD
Phone
8604866712
Email
neal.glaviano@uconn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren C Mangum, PhD
Phone
4078232795
Email
lauren.mangum@ucf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Glaviano, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal R Glaviano, PhD, ATC
Phone
860-486-6712
Email
neal.glaviano@uconn.edu
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Colby Mangum, PhD, ATC
Phone
407-823-2795
Email
lauren.mangum@ucf.edu
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M. Bazett-Jones, PhD, ATC
Phone
419-530-4241
Email
david.bazettjones@utoledo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD data will be available on request after manuscript has been published.

Learn more about this trial

Strength or Power Training for Patellofemoral Pain

We'll reach out to this number within 24 hrs