1 - WHAT IS PERSONALISED BLOOD FLOW RESTRICTION REHABILITATION (PBFR) TRAINING?
It is the application of a specialised tourniquet system to a proximal arm or leg, which is inflated, to a personalised 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.
2 - IS THERE ANY RESEARCH FOR PERSONALISED BLOOD FLOW RESTRICTION REHABILITATION? DOES IT WORK?
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 maximising 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 in the U.S.A. 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.
3 - HOW DOES PBFR WORK?
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.
4 - IS PBFR SAFE?
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 and CE 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.
5 - SO WHY WOULD I WANT TO DO THIS IN THE CLINICAL SETTING?
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.
6 - WHO IS CURRENTLY USING PBFR CLINICALLY?
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.
7 - SO WHY WOULD I WANT TO DO THIS 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.
8 - DO YOU HAVE A SPECIFIC TOURNIQUET SYSTEM THAT YOU RECOMMEND?
The Delfi Personalised Tourniquet System for Personalised 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 personalised 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 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 CE 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 Personalised 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 pressurised and for safety automatically deflates the cuff when the application time elapses. A clearly visible digital display of pressurisation time remaining is shown.
Reperfusion Timer for PBFR
After a PBFR cuff pressurisation cycle is completed, a programmable reperfusion timer prevents the cuff from being pressurised again until the reperfusion time has elapsed, helping ensure adequate time between pressurisation cycles for limb reperfusion.
PBFR Compliance Monitor
The PBFR compliance monitor automatically records key tourniquet parameters including: Limb Occlusion Pressure, Personalised Tourniquet Pressure, cuff inflation pressures, pressure application time and number of pressurisation 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 pressurisation. 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, pressurisation time and reperfusion time make set-up quick and easy.
Battery Back Up
Up to 4 hours of operation with a tested cuff.
9 - WHAT POPULATION OF PATIENTS IS THE DELFI PTS FOR PBFR INDICATED FOR?
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.
- Open fractures of the leg
- Post‑traumatic lengthy hand reconstruction
- Severe crushing injuries
- Diabetes mellitus
- Severe hypertension
- Elbow surgery (where there is concomitant excess swelling)
- Skin grafts in which all bleeding points must be readily distinguished
- Compromised vascular circulation, e.g., peripheral artery disease
- Sickle cell disease or trait (relative contraindication, see PRECAUTIONS IN USE).
- Secondary or delayed procedures after immobilisation.
10 - WHO CAN PURCHASE A DELFI PTS FOR PBFR SYSTEM FROM YOU?
At this time, only licensed medical healthcare providers practicing in the United Kingdom 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.
11 - WHAT DOES THE CERTIFICATION TRAINING INVOLVE?
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 personalised 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:
12 - I AM IN SCHOOL TO BECOME A LICENSED HEALTHCARE PROVIDER CAN I TAKE THE CERTIFICATION COURSE AND PURCHASE A UNIT?
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 Contact us
13 - HOW MANY UNITS CAN ONE CLINICIAN PURCHASE AFTER BECOMING CERTIFIED?
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.
14 - HOW LARGE IS THE UNIT, IS IT PORTABLE?
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.
15 - THE TOURNIQUET CUFFS ON THE DELFI PTS FOR PBFR LOOK DIFFERENT THAN THE NARROW CUFFS I HAVE SEEN.
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/8425355 High-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.
16 - WHAT IS LIMB OCCLUSION PRESSURE (LOP)?
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.
17 - CAN WE HAVE SOMEONE DO AN ON-SITE TRAINING AT OUR CLINIC, TEAM OR HOSPITAL?
18 - IS THERE ONGOING CLINICAL RESEARCH THAT YOU KNOW OF?
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.
19 - I AM PLANNING ON TAKING A PBFR CERTIFICATION COURSE; CAN I PRE-PURCHASE MY UNIT(S) SO THAT I HAVE IT AT THE COURSE?
Yes. Once we verify your submission 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.