Blood Flow Restriction Training After Patellar INStability (BRAINS)
Primary Purpose
Patellar Dislocation, Knee Injuries, Leg Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Training
Sham Blood Flow Restriction Training
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Dislocation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability
- Age 14 to 40 years
- Skeletally mature with closed growth plates visualized by radiograph
- A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week
- Desire to resume pre-injury activity level
Exclusion Criteria:
- Concomitant osteochondral lesion requiring surgical fixation
- Radiographic evidence of osteoarthritis (< Kellgren-Lawrence Grade 2)
- Previous ipsilateral or contralateral knee surgery
- Most recent instability event more than 3 months before enrollment
- History of any inflammatory disorder
- BMI > 35 kg/m2
- Diabetes or uncontrolled hypertension
- Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis
- Pre-existing conditions or previous surgeries that effect the ability to walk
- Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions
Sites / Locations
- UK Healthcare at TurflandRecruiting
- University of Kentucky Biomotion LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Physical Therapy with Sham BFRT
Standard Physical Therapy with BFRT
Arm Description
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Outcomes
Primary Outcome Measures
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
MRI T1rho
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
MRI T1rho
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Secondary Outcome Measures
MRI Muscle Volume
Quadriceps muscle volume (cm2)
The Norwich Patellar Instability Scale
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Quadriceps Strength Symmetry
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
MRI Muscle Volume
Quadriceps muscle volume (cm2)
MRI T1rho
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Full Information
NCT ID
NCT04554212
First Posted
August 31, 2020
Last Updated
April 6, 2023
Sponsor
Caitlin Conley
Collaborators
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04554212
Brief Title
Blood Flow Restriction Training After Patellar INStability
Acronym
BRAINS
Official Title
Blood Flow Restriction Training After Patellar INStability (BRAINS Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Caitlin Conley
Collaborators
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
Detailed Description
Participants will randomly be assigned to 1 of 2 groups. This means that neither the participant or their doctor will not choose the treatment, but that the treatment will be randomly selected (like a coin toss). The study treatments is blood flow restriction training (BFRT). BFRT uses an air cuff that is inflated around the top of the thigh. This temporarily limits blood flow to the muscles and may allow the participant to recover strength more quickly after injury. As will be described later, the participant will be closely monitored during all study treatments to make sure they are as safe as possible.
The two groups that participants could be assigned to are:
Standard physical therapy
Standard physical therapy and BFRT
Physical Therapy Sessions: We are comparing two physical therapy interventions, one is the standard of care and the other is the standard of care plus an additional treatment. Participants have a 50/50 chance of receiving either treatment. If randomized to receive BFRT, the air cuffs will then be placed on the participants' thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed.
The following procedures may be performed. Some procedures may not be performed due to time constraints, availability of equipment, and/or by the decision of the investigator. Before initiating physical therapy, participants will be asked some questions including but not limited to the following: age, sex, level of activities, and expectations. Participants will also complete a Sports Activity Scale to determine their physical activity level.
Timeline of Study Visits:
Visit 1 Screening and enrollment: Upon arriving at the clinic or Biomotion Laboratory, potential subjects will have the following assessments: range of motion and knee instability, both of which are the standard of care for a patient with a suspected patellar instability.
After providing informed consent to participate in the study, we will ask you to provide a urine sample and will collect about 2 teaspoons of blood for laboratory testing. The blood will be collected from your arm using standard venipuncture. In addition, we will ask you questions about your medical history including current medications, demographic information, BMI, and smoking status. You will be asked to complete three study questionnaires: the Norwich Patella Instability Score which asks questions about your knee, the Cincinnati Occupational Rating Scale which asks questions about the physical demands of your job or daily life, and a Visual Analogue Scale that will ask you to rate your current pain. You will be randomized to either standard physical therapy or standard physical therapy with BFRT. You have a 50/50 chance of having BFRT. We will also schedule you to go to the BioMotion laboratory for baseline strength testing and to have your first study MRI at the MRISC.
Visit 2 (1 week)
Knee and Hip Strength
Walking Biomechanics
MRI
Visit 3 (5 weeks)
Knee and Hip Strength
Questionnaires
Visit 4 (9 weeks)
Lab specimens collected (urine and about 2 teaspoons of blood)
Knee and Hip Strength
Walking Biomechanics
Questionnaires
Visit 5 (6 months)
Lab specimens collected (urine and about 2 teaspoons of blood)
Knee and Hip Strength
Walking and Running Biomechanics
Questionnaires
Visit 6 (1 year)
Lab specimens collected (urine and about 2 teaspoons of blood)
Knee and Hip Strength
Walking, Running, and Jumping Biomechanics
Questionnaires
MRI
Visit 7 (2 years)
Lab specimens collected (urine and about 2 teaspoons of blood)
Knee and Hip Strength
Walking, Running, and Jumping Biomechanics
Questionnaires
MRI
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Dislocation, Knee Injuries, Leg Injury, Wounds and Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Physical Therapy with Sham BFRT
Arm Type
Active Comparator
Arm Description
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Arm Title
Standard Physical Therapy with BFRT
Arm Type
Active Comparator
Arm Description
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Intervention Type
Device
Intervention Name(s)
Blood Flow Restriction Training
Intervention Description
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.
Intervention Type
Device
Intervention Name(s)
Sham Blood Flow Restriction Training
Intervention Description
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Primary Outcome Measure Information:
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
Baseline
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
5 Weeks
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
9 Weeks
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
6 Months
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
12 Months
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
1 Week
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
5 Weeks
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
9 Weeks
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
6 Months
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
12 Months
Title
MRI T1rho
Description
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Time Frame
1 Week
Title
MRI T1rho
Description
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
MRI Muscle Volume
Description
Quadriceps muscle volume (cm2)
Time Frame
12 Months
Title
The Norwich Patellar Instability Scale
Description
The Norwich Patellar Instability (NPI) Scale is a 19-item scale that asks subjects to rate their perceived patellar instability during different tasks, and has been demonstrated to be a valid and responsive tool for assessing patient-reported outcomes for those being treated conservatively or surgically following patellar dislocation. The NPI is scored on a scale of 0 to 100, with lower scores being indicative of less perceived instability
Time Frame
24 Months
Title
Quadriceps Strength Symmetry
Description
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Time Frame
24 Months
Title
MRI Muscle Volume
Description
Quadriceps muscle volume (cm2)
Time Frame
24 Months
Title
MRI T1rho
Description
Increased T1rho relaxation times have been associated with loss of proteoglycan content. This then corresponds with MRI changes associated with the loss of proteoglycan content. Patients with patellofemoral pain and maltracking have been demonstrated to have significantly greater T1rho relaxation times in the lateral facet of the patella when compared to healthy volunteers.
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of traumatic patellar instability (either primary or recurrent) determined by an American Board of Family Medicine certified physician with a Certificate of Added Qualifications in Sports Medicine or licensed Physical Therapist utilizing clinical examination, radiographic imaging, and patients' reports of instability
Age 14 to 40 years
Skeletally mature with closed growth plates visualized by radiograph
A score of 80 or more on the Sports Activity Scale, which corresponds to participating in "running, twisting, turning (tennis, racquetball, handball, ice hockey, field hockey, skiing, wrestling)" at least 1-3 times per week
Desire to resume pre-injury activity level
Exclusion Criteria:
Concomitant osteochondral lesion requiring surgical fixation
Radiographic evidence of osteoarthritis (< Kellgren-Lawrence Grade 2)
Previous ipsilateral or contralateral knee surgery
Most recent instability event more than 3 months before enrollment
History of any inflammatory disorder
BMI > 35 kg/m2
Diabetes or uncontrolled hypertension
Varicose veins or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis
Pre-existing conditions or previous surgeries that effect the ability to walk
Planned trips or vacations that will result in the inability to attend 4 consecutive physical therapy sessions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Conley, PhD
Phone
8592571939
Email
caitlin.conley2@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cale Jacobs
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
UK Healthcare at Turfland
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Conley, PhD
Phone
859-257-1939
Email
caitlin.conley2@uky.edu
Facility Name
University of Kentucky Biomotion Laboratory
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Noehren, PhD, PT
Phone
859-218-0581
Email
b.noehren@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35090543
Citation
Brightwell BD, Stone A, Li X, Hardy P, Thompson K, Noehren B, Jacobs C. Blood flow Restriction training After patellar INStability (BRAINS Trial). Trials. 2022 Jan 28;23(1):88. doi: 10.1186/s13063-022-06017-1.
Results Reference
derived
Learn more about this trial
Blood Flow Restriction Training After Patellar INStability
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