Back to resultsThe Effect of Blood Flow Restriction Method in Patellar Instability
Primary Purpose
Patellar Abnormality
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation with blood blow restriction
Rehabilitation without blood flow restriction
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Abnormality
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18-40 years,
- Volunteering to participate in the study,
- Having a complaint of anterior knee pain for at least 3 months,
- Having been diagnosed with unilateral minor patellar instability,
- Absence of any other ongoing clinical problems that interfere with exercise (will be questioned by the Physical Activity Readiness Questionnaire for All).
Exclusion Criteria:
- History of one or more traumatic-atraumatic patella dislocations,
- Evidence of osteoarthritis on radiological imaging (≥ Kellgren-Lawrence Stage 2)
- Having at least one of the contraindications preventing the application of blood flow restrictive exercises (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index <0.9), coronary heart disease, hypertension, hemophilia, etc.),
- Previously diagnosed cardiovascular disease limiting effort capacity (Myocardial infarction, angina, exercise intolerance, etc.),
- Previously diagnosed neurological disorder or cognitive dysfunction (stroke, dementia, schizophrenia, etc.),
- Orthopedic lower extremity surgery in the last 1 year,
- Body mass index ≥ 30 kg/m2.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
With Blood Flow Restriction
Without Blood Flow Restriction
Arm Description
Outcomes
Primary Outcome Measures
Assessment of Muscle Architecture and Hypertrophy
A portable, diagnostic B-mode ultrasound device with a linear probe will be used to evaluate the quadriceps muscle architecture. Cross-sectional areas, muscle thicknesses, fascicle lengths, and pennation angles, the architectural parameters of both thigh muscles, will be assessed by ultrasound. All assessments will be calculated as millimeters.
Secondary Outcome Measures
Assessment of Muscle Strength
The concentric and eccentric strength of the knee extensor muscle (quadriceps) and its antagonist (hamstring), will be measured using the isokinetic dynamometer.
Assessment of Pain
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain in the knee of patients during activity, at rest, and at night. In the evaluation of pain intensity with VAS, the patient is asked to mark his pain above the 10-centimeter line defined as "0-no pain" and "10 unbearable pain" at both ends.
Evaluation of Functions
The Tampa Kinesiophobia Scale (TKS) will be used to evaluate kinesiophobia. The lower extremity functional capacity of the subjects will be evaluated with the 1-minute sit-to-stand test, and the knee functions will be evaluated with the Lysholm Knee Scoring Scale and the Kujala Patellofemoral Joint Evaluation Scale, which are patient-answered scales that are recommended to be used in cases with patellar instability. In addition, fatigue determination after each application will be made with the Borg CR-10 Perceived Fatigue Scale. Scales will be filled by the face-to-face evaluation method.
Evaluation of Satisfaction and Change
General satisfaction and the change in clinical status perceived by the participants will be evaluated with the 7 points Global Rating of Change Scale after the rehabilitation program. According to the scale, it is expressed as "-3: I am much worse, -2: I am worse, -1: I am a little worse, 0: No change, 1: I am a little better, 2: I am better, 3: I am much better".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484141
Brief Title
The Effect of Blood Flow Restriction Method in Patellar Instability
Official Title
The Effect of Blood Flow Restriction Applied to the Extensor Muscles on Muscle Architecture and Strength, Knee Pain, and Functions in Minor Patellar Instability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
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 blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.
Detailed Description
Patellar instability is defined as disruption of normal movement of the patella in the trochlear groove, symptomatic, medial-lateral displacement. Patients with patellar instability may not be able to tolerate high-intensity quadriceps exercises in the early period of strengthening programs due to pain symptoms, and therefore strength recovery may be delayed. However, it is important to restore muscle strength, especially vastus medialis obliquus strength, as early as possible in patellar instability. The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Abnormality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
With Blood Flow Restriction
Arm Type
Experimental
Arm Title
Without Blood Flow Restriction
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Rehabilitation with blood blow restriction
Intervention Description
The rehabilitation program will be applied 2 days a week, for total of 8 weeks.
Intervention Type
Other
Intervention Name(s)
Rehabilitation without blood flow restriction
Intervention Description
The rehabilitation program will be applied 2 days a week, for total of 8 weeks.
Primary Outcome Measure Information:
Title
Assessment of Muscle Architecture and Hypertrophy
Description
A portable, diagnostic B-mode ultrasound device with a linear probe will be used to evaluate the quadriceps muscle architecture. Cross-sectional areas, muscle thicknesses, fascicle lengths, and pennation angles, the architectural parameters of both thigh muscles, will be assessed by ultrasound. All assessments will be calculated as millimeters.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Assessment of Muscle Strength
Description
The concentric and eccentric strength of the knee extensor muscle (quadriceps) and its antagonist (hamstring), will be measured using the isokinetic dynamometer.
Time Frame
8 weeks
Title
Assessment of Pain
Description
Visual Analogue Scale (VAS) will be used to evaluate the severity of pain in the knee of patients during activity, at rest, and at night. In the evaluation of pain intensity with VAS, the patient is asked to mark his pain above the 10-centimeter line defined as "0-no pain" and "10 unbearable pain" at both ends.
Time Frame
8 weeks
Title
Evaluation of Functions
Description
The Tampa Kinesiophobia Scale (TKS) will be used to evaluate kinesiophobia. The lower extremity functional capacity of the subjects will be evaluated with the 1-minute sit-to-stand test, and the knee functions will be evaluated with the Lysholm Knee Scoring Scale and the Kujala Patellofemoral Joint Evaluation Scale, which are patient-answered scales that are recommended to be used in cases with patellar instability. In addition, fatigue determination after each application will be made with the Borg CR-10 Perceived Fatigue Scale. Scales will be filled by the face-to-face evaluation method.
Time Frame
8 weeks
Title
Evaluation of Satisfaction and Change
Description
General satisfaction and the change in clinical status perceived by the participants will be evaluated with the 7 points Global Rating of Change Scale after the rehabilitation program. According to the scale, it is expressed as "-3: I am much worse, -2: I am worse, -1: I am a little worse, 0: No change, 1: I am a little better, 2: I am better, 3: I am much better".
Time Frame
8th week
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:
Being between the ages of 18-40 years,
Volunteering to participate in the study,
Having a complaint of anterior knee pain for at least 3 months,
Having been diagnosed with unilateral minor patellar instability,
Absence of any other ongoing clinical problems that interfere with exercise (will be questioned by the Physical Activity Readiness Questionnaire for All).
Exclusion Criteria:
History of one or more traumatic-atraumatic patella dislocations,
Evidence of osteoarthritis on radiological imaging (≥ Kellgren-Lawrence Stage 2)
Having at least one of the contraindications preventing the application of blood flow restrictive exercises (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index <0.9), coronary heart disease, hypertension, hemophilia, etc.),
Previously diagnosed cardiovascular disease limiting effort capacity (Myocardial infarction, angina, exercise intolerance, etc.),
Previously diagnosed neurological disorder or cognitive dysfunction (stroke, dementia, schizophrenia, etc.),
Orthopedic lower extremity surgery in the last 1 year,
Body mass index ≥ 30 kg/m2.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Begüm KARA KAYA, MSc
Phone
+905355720021
Email
bkara@biruni.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Zengin Alpözgen, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Blood Flow Restriction Method in Patellar Instability
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