Blood Flow Restriction Training, Aspiration, and Intraarticular Normal Saline

Summary

Participation Requirements

Description

Participants will randomly be assigned to 1 of 4 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 two study treatments are saline injection and blood flow restriction training (BFRT...

Participants will randomly be assigned to 1 of 4 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 two study treatments are saline injection and 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 four groups that participants could be assigned to are: Knee injection with standard physical therapy Injection without saline but with standard physical therapy and BFRT Knee injection with standard physical therapy and BFRT Injection without saline but with and standard physical therapy Knee Aspiration and Saline Injection: All patients will have an injection of a numbing medication called lidocaine in the skin on the side of the knee. During a knee aspiration the study doctor will remove fluid from the space around the knee using a needle and syringe. A spray will be used to numb your skin in the area. Then the participant will have the numbing injection in the skin on the side of the knee. YKnee aspirations after knee injury are a common orthopaedic practice to either relieve swelling or to obtain fluid for analysis to diagnose a joint disorder and/or problem. After the fluid is drawn off the knee, the study doctor will inject two tablespoons of saline into the knee. There are no known side effects of this treatment. There is a 50/50 chance that participants will either have only the numbing medication injection or an injection of the numbing medication followed by a saline injection. 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 potential subjects will have the following assessments: range of motion, knee instability and standardized bent knee weight bearing x-rays, all of which are the standard of care for a patient with a suspected patella dislocation. After providing informed consent to participate in the study, investigators will ask participants to provide a urine sample and will collect about 2 teaspoons of blood for laboratory testing. The blood will be collected from the arm using standard venipuncture. In addition, investigators will ask participants questions about their medical history including current medications, demographic information, BMI, and smoking status. Participants will be asked to complete three study questionnaires: the Norwich Patella Instability Score which asks questions about the knee, the Cincinnati Occupational Rating Scale which asks questions about the physical demands of their job or daily life, and a Visual Analogue Scale that will ask participants to rate their current pain. Participants will be randomized to either have a saline injection or no knee injection. Participants have a 50/50 chance of having the injection. Investigators will also schedule you to go to the BioMotion laboratory for baseline strength testing and to have the first study MRI. Visit 2 (1 week) Knee and Hip Strength Walking Biomechanics MRI Visit 3 (5 weeks) Lab specimens collected (urine and about 2 teaspoons of blood) 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 (12 months) Lab specimens collected (urine and about 2 teaspoons of blood) Knee and Hip Strength Walking, Running, and Jumping Biomechanics Questionnaires MRI Participants will receive up to $500.00 for taking part in this study. Participants will receive a $100 payment for completing each of the 5 study testing visits ($500 total if all visits are attended).

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