The Effect of Blood Flow Restriction Method in Patellar Instability

The Effect of Blood Flow Restriction Applied to the Extensor Muscles on Muscle Architecture and Strength, Knee Pain, and Functions in Minor 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patellar Abnormality
• Intervention / Treatment: Other: Rehabilitation with blood blow restriction; Other: Rehabilitation without blood flow restriction

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Begüm KARA KAYA, MSc; Phone Number: +905355720021; Email: bkara@biruni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With Blood Flow Restriction	Other: Rehabilitation with blood blow restriction; The rehabilitation program will be applied 2 days a week, for total of 8 weeks.
Active Comparator: Without Blood Flow Restriction	Other: Rehabilitation without blood flow restriction; The rehabilitation program will be applied 2 days a week, for total of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
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.	8 weeks
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.	8 weeks
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".	8th week

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Study Director: Ayşe Zengin Alpozgen, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: PFI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No