"Regenerative" Injections- Let's Be Honest Here

Concerned. Disappointed. Those are the first words that come to mind when I read or hear about another non-physician advertising “regenerative” injections, such as stem cell or platelet-rich plasma. I’ll be honest here…the greatest number of advertisements come from the practices of chiropractors. Here’s the irony: chiropractors cannot legally give orthopedic-based injections. So, what’s the catch? Most hire mid-level providers, physician assistants (PAs) or nurse practitioners (NPs), to give these injections. Mid-levels serve very valuable roles in our healthcare system. Some are skilled enough to provide injections in a very competent fashion. However, our medical system has been designed such that mid-levels are mentored and directly supervised by medical doctors who have expertise in providing procedures such as injections. In the case of a chiropractor’s office, how can the supervising chiropractor mentor or teach the mid-level to do an injection when he or she has never given a joint, tendon or other similar injection in his or her entire career? It just doesn’t make sense, plain and simple. Then, you are talking about very advanced injections, most of which are not covered by insurance and cost the patient hundreds to thousands of dollars. Finally, many of these injections done by mid-levels are not guided in any fashion, meaning neither ultrasound nor fluoroscopy (live x-ray) is used. Thus, the accuracy of the injection is likely less than optimal.

Here’s the bottom line: even with all the radio, magazine, TV and social media advertising done by some practices claiming to be experts in “regenerative injections,” you need to carefully choose who you want to provide these advanced office procedures. I have a very healthy respect for several of my colleagues who are chiropractors. I freely refer to them. They do an excellent job with care of the spine and rehabilitation of some extremity issues as well. However, orthopedic injections are just not in their wheelhouse.

At Impact Sports Medicine and Orthopedics, we have used ultrasound guidance for 10 years and only after taking a minimum of 6 courses on the subject. We are carefully studying the science and trends pertaining to regenerative injections and have provided these to our patients over the past 8 years. We are not the only ones in the Nashville area doing these advanced injections, but you will be hard-pressed to find any practice more experienced or dedicated to the honesty and integrity of the process.

-F. Clarke Holmes, M.D.

The Top 5 Reasons to Have an Orthobiologic Injection

Regenerative injections, also known as orthobiologic injections, include platelet-rich plasma (PRP), amniotic membrane and fluid, alpha-2 macroglobulin and mesenchymal stem cell (MSC)

1)      Cortisone has not gotten the job done- corticosteroid injections are potent anti-inflammatories and can be effective in treating inflammatory conditions, but these have either zero or even a detrimental effect on healing. Most chronic tendon problems are not inflammatory, and thus, cortisone will provide minimal long-term benefit. Not all cases of arthritis are inflammatory either.

2)      You are hoping to avoid surgery or you had surgery and are less than satisfied- we know that certain surgeries produce superior outcomes compared to nonsurgical treatment, particularly in younger and active individuals. Examples include ACL reconstruction after a full ACL tear and shoulder stabilizing procedures after multiple dislocations. However, there are numerous conditions that have equal or superior outcomes with nonsurgical treatment. These include small tears of the rotator cuff, hamstring, patellar and Achilles tendons; plantar fasciitis; degenerative meniscal tears; tennis and golfer’s elbow and mild to moderate osteoarthritis of the knee, hip, shoulder and basal thumb joint. These conditions are ideal candidates for regenerative injections, especially when traditional surgical and nonsurgical treatments are not producing major levels of benefit

3)      Cost- no, insurance does not cover regenerative injections. However, these injections are designed to provide long-term or permanent benefit. The expected goals are months to years of reduction in pain, improvement in function, soft tissue healing and slowing or suspending joint degeneration, i.e., preventing osteoarthritis from getting worse. Thus, these injections have a very good chance of saving you money. These benefits translate into fewer physician’s visits, fewer trips to physical therapy (although we still see the value of PT), fewer medications and potentially, the elimination of the need for an expensive surgery.

4)      You want a game-changing treatment, not one that just treats symptoms- regenerative injections are designed to change the environment of the area injected. Through the introduction of nutrients, growth factors and potentially stem cells, the goal of these injections is to not only make a patient feel and function better, but also to produce a healing response. This can mean tendon or ligament re-growth, cartilage regeneration and/or the reduction of unhealthy inflammation in the area of damage.

5)      The medical literature- although insurance companies would like to paint orthobiologic injections as “experimental” and thus not pay for them, the truth is that there are now hundreds of studies that demonstrate a clinically significant benefit in the treatment of chronic tendon problems and osteoarthritis with regenerative injections. In fact, hot off the press, a prominent sports medicine journal just posted a detailed review of orthobiologic injections. The authors came to this conclusion:  There was a total of 21 PRP (platelet-rich plasma) studies in the study. All PRP studies showed clinical improvement with PRP therapies in outcomes surveys measuring patient satisfaction, pain, and function…. The one PRP study that had a 2nd look arthroscopy reported increased cartilage regeneration with PRP. All 8 MSC (mesenchymal stem cell) studies with follow-up MRI and all 7 MSC studies with 2nd look arthroscopy showed improvement in cartilage regeneration in terms of coverage, fill of the defect, and/or firmness of the new cartilage.

Translation: patients are very satisfied with their outcomes after receiving these injections. Although we do not make guarantees about cartilage re-growth, improvement in the integrity of the cartilage after these injections is a possibility.

In conclusion, orthobiologic injections are rapidly entering and evolving within the world of orthopedic medicine. At this point, both their present and future look very bright. When considering a “regenerative” injection, seek the consultation of a medical doctor who has vast experience in researching and performing these procedures.

-Clarke Holmes, M.D. 

The Guide to Regenerative Injections

Dr. Holmes’ Guide to Regenerative Injections

Regenerative injections are those specifically utilized to promote healing of damaged tissue, reduce or eliminate unhealthy inflammation and slow or halt the progression of soft tissue and joint deterioration. We now use them regularly for tendon problems including tennis elbow, golfer's elbow, the rotator cuff, the high hamstring, patellar and Achilles tendons. We also have seen great success in treating osteoarthritis of the knees, shoulders, hips, thumb and great toe joints. Plantar fasciitis, ligament and muscle tears are great candidates for regenerative injections as well. 

·      Platelet-Rich Plasma Injections

o   Blood obtained from an arm vein is centrifuged for 15-20 minutes, isolating the platelet-rich plasma

o   Platelets are very rich in our natural growth factors (healing agents), and are concentrated 6-10 times their natural concentration

o   Under ultrasound-guidance, the PRP is injected into the damaged tendon, ligament, fascia, joint or muscle

o   Great option for tennis elbow, golfer’s elbow, small rotator cuff tears, small patellar tendon tears, high hamstring tendon tears, Achilles tendon tears, plantar fasciitis, etc.

o   Widely-used also for osteoarthritis of numerous joints

o   PROS: very natural and safe (your blood); used in orthopedics for ~10 years, Dr. Holmes has used for 7 years; numerous medical studies confirm significant benefit; 2-3 areas can be injected at one time; long-term benefit for most patients

o   CONS: these work gradually, over weeks to months; increased pain after the procedure for 2 days to 2 weeks; immobilization required with a splint or boot for some injections

o   UNKNOWNS: length of benefit (can be months to years); number and frequency of required injections. 1-2 injections initially for most soft tissue problems; 2-3 initially for arthritis/joint problems

·      Amniotic Membrane Allograft Injections (brand- AmnioFix)

o   Utilize one of the placental membranes (these cover the fetus during pregnancy) to form a product containing numerous types of growth factors

o   Intended to reduce inflammation, reduce scar tissue formation and enhance healing

o   The membrane undergoes a rigorous purification and sterilization process, and is stored as a dehydrated powder; sterile saline is added to become an injectable solution

o   Great option for plantar fasciitis (#1 use), tennis elbow, golfer’s elbow, small rotator cuff tears, small patellar tendon tears, high hamstring tendon tears and small Achilles tendon partial tears

o   PROS: very safe, with no significant reportable adverse effects; Dr. Holmes has used for 5 years; no rejection, despite not being one’s own tissue; no blood draw required; typically less post-procedure pain than PRP

o   CONS: probably not as effective for joint pain/arthritis; otherwise, same cons as PRP

·      Amniotic Fluid Injections (brand- Catalyst PDA-HAF)

o   Very similar to amniotic membrane injections, but often stored in a frozen form and thawed immediately before injection

o   Contain over 200 different growth factors

o   Great option for soft tissue as well as joint problems such as osteoarthritis

o   PROS: theoretically, a more powerful amniotic product than a dehydrated membrane

o   CONS: more expensive than the dehydrated membrane product

·      Alpha-2-Macroglobulin Injections

o   A natural substance found in our bloodstream

o   Blood drawn from the patient, centrifuged, manually separated and then placed in a separation pump to further isolate and concentrate the A2M

o   45-minute procedure done in one office visit

o   Functions as a “protease inhibitor,” binding the inflammatory proteins that cause the degradation of cartilage in the joint

o   Utilized to reduce pain, inflammation, halt the progression of osteoarthritis and provide “longevity” to the joint

o   PROS: very safe and natural substance; presumed long-term benefit, less post-procedure discomfort than other injections; two to three injection sites can often be chosen with one procedure

o   CONS: newest type of regenerative injection; very few medical studies proving effectiveness thus far, but studies are underway; frequency of injections not known at this point (likely every 6-24 months)

With any of these injections, all forms of ORAL and TOPICAL anti-inflammatories must be stopped for 1 week before and 2 weeks after, as to not interrupt the initial healing cascade initiated by the injections. This includes:

·      Advil/Motrin/ibuprofen

·      Aleve/naproxen

·      Aspirin- any doses above 81 mg

·      Mobic/meloxicam, Celebrex/celecoxib, Voltaren/diclofenac

·      Fish oils/Omega-3 fatty acids

·      Turmeric

·      Oral green tea

·      Glucosamine/chondroitin

·      Arnica

COST: Regenerative injections are rarely ever covered by insurance. Although we closely monitor their coverage status, in the current climate of healthcare and insurance companies reducing their coverage of even typical treatment measures, we do not expect these injections to be covered in the near future.

With rising deductibles, many patients pay out-of-pocket for traditional treatment measures as well. Thus, a regenerative injection may ultimately be a similar out-of-pocket cost to traditional treatments but more clinically effective and cost-effective over the long-term.

A patient should view these injections as an investment into the long-term health of their tendons, fascia, ligaments and joints.

We are here to serve you! 

F. Clarke Holmes, M.D.