It is the application of a specialized tourniquet system to a proximal arm or leg, which is inflated, to a personalized and specific pressure to reduce blood flow to an exercising extremity. The application is brief and intermittent, typically about 6 minutes per exercise but can last up to 30 minutes based on the specific protocol. Typically, to increase strength and hypertrophy a person would need to lift a significant amount of weight (60% of a 1 Repetition maximum or greater). With PBFR you can create significant strength and hypertrophy gains with loads as low as 20% 1RM.
Yes, there is a substantial amount of literature that has studied the effects of PBFR. In fact, a recent meta-analysis found a total of 820 articles pertaining to PBFR. The authors of the review concluded “Importantly, research suggests that low load resistance exercise (20–30% 1 RM) and low load aerobic exercise (<70 m/min walk training), which would not be expected to cause considerable increases in muscular quantity or quality under normal circumstances, when combined with PBFR produced an exaggerated response for maximizing muscle strength and hypertrophy.” http://www.jsams.org/article/S1440-2440(15)00182-6/abstract?cc=y=
PBFR consistently demonstrates greater results compared to work matched controls exercising without PBFR. The positive results have been seen in patients after injury, in the elderly, and in athletes. It has also been applied extensively in a military rehabilitation setting on severely compromised patients. http://www.defense.gov/news/newsarticle.aspx?id=123685
Upon completion of the certification course, the clinician will be very well versed in the PBFR literature, the scientific rational as well as how to apply it clinically.
The exact mechanism behind the positive results seen with PBFR is still being extensively researched. Theories range from a significant build up of metabolites by anaerobic metabolism, a systemic anabolic response and cellular swelling. It is most likely a combination of multiple factors. It does appear that muscle protein synthesis plays a primary role as this has been consistently demonstrated in the literature.
PBFR has consistently demonstrated to be a safe modality in the literature. It has been performed on thousands of subjects in the peer-reviewed literature with little to no side effects. Clinicians are always encouraged to use an FDA device listed tourniquet system specifically indicated for PBFR use and with built in safety features such as the ability to detect limb occlusion pressure when performing PBFR.
After injury or surgery a patient is usually unable to lift significant loads to induce a strength or hypertrophy response in skeletal muscle. PBFR allows the clinician to begin the strength and hypertrophy phases of rehabilitation much earlier. PBFR has demonstrated statistically significant improved patient outcomes after anterior cruciate ligament surgery both acutely and chronically. http://www.ncbi.nlm.nih.gov/pubmed/11128848http://www.ncbi.nlm.nih.gov/pubmed/12635796 Very compromised patients suffering inflammatory muscle wasting diseases such as polymyositis and dermatomyositis have also demonstrated positive results without any potential safety risks. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4232679/ It has also demonstrated improved results in patients who have suffered severe musculoskeletal trauma https://www.jsomonline.org/Newsletter/140715.html and in women with risk factors for symptomatic knee osteoarthritis http://www.ncbi.nlm.nih.gov/pubmed/25289840. Clinically we have applied it to many diagnoses with very positive results including but not limited to total joint arthroplasties, Achilles repairs, fractures, rotator cuff repairs, muscle strains, nerve injuries, post-operative knee reconstructions and cartilage repairs, and tendinopathies.
Currently, we have trained large healthcare systems, professional sports teams, private clinics, Physical Therapy/Occupational Therapy schools, NCAA athletic departments and the military in the application and use of PBFR in the clinical setting.
Tourniquets are classified and regulated Class I devices by the FDA. We would not recommend that a clinician use a device that has not been device listed with the FDA and not indicated for PBFR use specifically to occlude blood flow on a patient in the clinical setting. Knee wraps, blood pressure cuffs and other devices suggested for PBFR that have not been device listed with the FDA and specifically indicated for PBFR use to occlude blood flow may cause injury to the patient and may leave the clinician susceptible to liability.
Using a 3rd generation tourniquet system that has been device listed with the FDA and specifically indicated for PBFR use that determines each patient’s individual limb occlusion pressure (how much pressure is required to reduce or completely eliminate blood flow), is attached to a system that self calibrates and maintains the designated pressure, allows rapid inflation and deflation of the tourniquet cuff and utilizes wide and contoured cuffs to reduce pressure gradients can all decrease potential injury risks to the patient.
The Delfi Personalized Tourniquet System for Personalized Blood Flow Restriction Rehabilitation (PTS for PBFR) is currently the only tourniquet system we recommend for blood flow restriction rehabilitation in the clinical setting. Delfi Medical Innovations Inc. is a world leader in personalized tourniquet technology, development and evaluation. For more than 30 years, members of the Delfi team have been extensively involved in improving tourniquet safety through the development and evaluation of new technologies. (See www.tourniquets.org for more information). The team is led by James McEwen, Ph.D., P.Eng. Dr. McEwen is the inventor of the automatic surgical tourniquet, and holds patents for much of the advanced tourniquet technology that is now in widespread use in the United States and elsewhere around the world. Delfi’s tourniquet products are used in countries around the world, including the United States, Japan, Korea, Australia, Europe, Canada, Mexico and Chile.
The Delfi PTS for PBFR is a tourniquet system device listed with the FDA and specifically indicated for PBFR use. It features:
Delfi’s patented Limb Occlusion Pressure (LOP) technology allows a patient specific LOP to be measured and automatically calculates the patient’s Personalized Tourniquet Pressure (PTP) as percentage of LOP.
PBFR Pressure Application Timer
An easily adjusted PBFR pressure application timer controls the length of time that the cuff will remain pressurized and for safety automatically deflates the cuff when the application time elapses. A clearly visible digital display of pressurization time remaining is shown.
Reperfusion Timer for PBFR
After a PBFR cuff pressurization cycle is completed, a programmable reperfusion timer prevents the cuff from being pressurized again until the reperfusion time has elapsed, helping ensure adequate time between pressurization cycles for limb reperfusion.
PBFR Compliance Monitor
The PBFR compliance monitor automatically records key tourniquet parameters including: Limb Occlusion Pressure, Personalized Tourniquet Pressure, cuff inflation pressures, pressure application time and number of pressurization cycles.
Advanced Pressure Regulation
The same advanced pressure regulation technology as used in our surgical tourniquets maintains the cuff near the selected pressure during limb movement.
Audio and visual alarms warn of cuff over and under pressurization. Self test and calibration test on start-up verify proper instrument operation.
Intuitive User Interface
An easy to read color LCD display along with intuitive controls simplifies the adjustment of key tourniquet parameters.
Integrated Tourniquet Cuff Testing
Cuffs, tubing and connectors may be automatically tested for leaks before or after use.
User configurable default values for PTP percentage, cuff pressure, pressurization time and reperfusion time make set-up quick and easy.
Battery Back Up
Up to 4 hours of operation with a tested cuff.
INDICATIONS FOR USE
This device is indicated for use on patients for whom a physician or physician’s designated licensed healthcare practitioner has indicated perioperative blood flow restricted exercise.
The population of patients shall be drawn from those patients who require or may require invasive medical procedures to affect the structure or function of limbs and/or to treat or mitigate diseases associated with limb anatomy or physiology.
Refer to the medical literature for possible contra-indications to tourniquet use. A partial list is provided below; however in every case the final decision to use a tourniquet rests with the attending physician or physician’s designated licensed healthcare practitioner.
At this time, only licensed medical healthcare providers practicing in the United States that have completed a PBFR certification training may purchase a Delfi PTS for PBFR system. This includes, but is not limited to, Medical Doctors, Physical Therapists, Athletic Trainers, Chiropractors and Occupational Therapists.
The certification course is part didactic and lab. The course is 8.5 hours in length with approximately 60% didactic and 40% lab. The clinician will learn to understand the science behind personalized blood flow restriction rehabilitation (PBFR) training and how to apply PBFR in the clinical setting. Click on the link for a full list of course objectives:
If you are currently a student enrolled in a healthcare program you may take the certification course. Upon successful completion of the course you will be able to purchase a unit once you obtain your healthcare license. Healthcare students qualify for a discounted rate for the certification course. Send inquiries to http://www.owensrecoveryscience.com/contact/
A medical professional that has completed PBFR certification training may purchase up to 4 Delfi PTS for PBFR units. The trained clinician will be responsible for the supervision of other untrained medical staff using the equipment.
The unit is very light and portable. The exact dimensions of the tourniquet pump are:
Height: 180 mm (7.0 inches)
Width: 120 mm (4.7 inches)
Depth: 110 mm (4.3 inches)
Weight: 1.08 kg (38.0 oz)
In the clinical setting using a rolling stand makes it very easy to move the system. See our product page for examples.
The use of wider and contoured cuffs creates a better fit around the patient’s limb, which can reduce the pressure needed directly under the cuff. Narrow tourniquet cuffs require significantly greater pressure to create the same occlusive effect. http://www.ncbi.nlm.nih.gov/pubmed/8425355High-pressure gradients can lead to injury of nervous and other soft tissue structures directly under the cuff. http://www.nature.com/nature/journal/v233/n5317/abs/233265a0.html A great resource for all information on tourniquet use and safety can be found at www.tourniquets.org.
LOP is the minimum pressure required, at a specific time in a tourniquet cuff applied to an individual patient’s limb at a specific location, to stop the flow of arterial blood into the distal limb of the cuff. It is well established in the medical literature that the optimal guideline for setting the pressure of a tourniquet is based on Limb Occlusion Pressure (LOP). It can vary based on the size of the patient’s limb, systolic blood pressure, and cuff width and placement. Using a system with the ability to detect LOP accounts for all of these variables.
At this time, there is no specific billing code for PBFR. However, you perform exercise while performing PBFR which allows the clinician to bill therapeutic exercise (97110) while doing PBFR. In todays outcome driven healthcare system the ability to potentially improve exercise results with the addition of PBFR can be very beneficial to the clinician.
Yes. You have the ability to lease to own or rent Delfi PTS for PBFR units. Go to http://www.owensrecoveryscience.com/purchase/ for options. Of note, the lease and rental prices are based on credit score and may be reduced based on your credit score. At present, the purchase/rental or lease of this product is permitted only in the United States and can only be made by a qualified health care professional who has completed an appropriate PBFR training program.
The American Physical Therapy Association recently performed a 10 state review spread geographically across the United States to determine if PBFR falls within those states practice acts. The APTA determined that PBFR does fall within each of those states practice acts for Physical Therapists. See review here: *************(I will give you the [JO1] )******
Our clients include hospital systems, professional sports teams, private Physical Therapy clinics, private Chiropractic clinics and Physical Therapy schools. All of these institutions are currently performing PBFR on patient populations using the Delfi PTS for PBFR.
Yes. Some institutions find it is more cost effective to train their entire staff on-site rather than send multiple clinicians to a certification course. Follow the link http://www.owensrecoveryscience.com/certification/ for more information or to ask a specific question click http://www.owensrecoveryscience.com/contact/.
Yes, studies that we are involved in include prospective trials of PBFR after knee arthroscopy, anterior cruciate ligament reconstruction, chronic thigh weakness after surgery, femur fractures, Achilles tendinopathy, meniscal repairs and distal radius fractures. A rotator cuff repair study has been submitted for funding. Future potential trials based on positive clinical results include joint arthroplasty, nerve injuries and muscle strains.
Yes. Once we verify your enrollment in a PBFR certification course we will ship your unit(s) either to the course or plan to have it shipped to your physical address to coincide with you completion of the course.
Not only does using a medical device greatly improve the benefits of the BFR technique, but it is also recommended and regulated by the FDA. Knee wraps, blood pressure cuffs and other devices suggested for PBFR that have not been device listed with the FDA and specifically indicated for PBFR use to occlude blood flow may cause injury to the patient and may leave the clinician susceptible to liability. In the United States, healthcare practitioners must use an FDA listed device to safely and effectively perform blood flow restriction rehabilitation. Additionally, healthcare practitioners must have certification to perform blood flow restriction rehabilitation. You can read more about BFR requirements from Delfi here. You can also check out the FDA's Requirements for Pneumatic Tourniquets in the United States here.