Disclosures 10/10/17. Low Risk, High Success: Prolotherapy Regenera:ve Medicine for Osteoarthri:s. Nothing to disclose.

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HEMWALL CENTER FOR ORTHOPEDIC REGENERATIVE MEDICINE

COM 28 th Annual Mee1ng, San Diego, CA October 20,

Disclosures Chronic musculoskeletal pain is the most

1 Low Risk, High Success: Prolotherapy Regenera:ve Medicine for Osteoarthri:s DONNA ALDERMAN, D.O. HEMWALL CENTER FOR ORTHOPEDIC REGENERATIVE MEDICINE 28 th Annual Mee1ng, San Diego, CA October 20, 2017 Nothing to disclose. Disclosures Chronic musculoskeletal pain is the most common medical complaint in the U.S., with $100 billion spent annually on its management. Bashir, et al. Physical Medicine and Rehabilita1on, 2014; 6:61-69 ; Uhl,et al. Journal of the American Academy of Orthopedic Surgeons. 2014;22(2);. 1

According to 2017 sta1s1cs, osteoarthri1s affects more than 30 million adults in the US alone. Center for Disease Control and Preven1on, last updated February 2017, hwps://www.cdc.

2 According to 2017 sta1s1cs, osteoarthri1s affects more than 30 million adults in the US alone. Center for Disease Control and Preven1on, last updated February 2017, hwps:// Typical medical recommenda:ons: RX: side effects/addic:on poten:al/only temporary; *Opioid epidemic: NEJM reports overdoses have quadrupled in the last 15 years (Frieden et al. 2016). *NSAIDs: In addi1on to GI/cardiac side effects, may be a cause of car1lage damage and progression of osteoarthri1s. (Hauser, Journal of Prolotherapy, 2010; Huskisson et al. Journal of Rheumatology ). Cor:sone: adverse effects on joint/1ssue/ temporary; Physical Therapy/Osteopathic/Chiroprac:c: can be helpful, but may not always resolve issue/pain; Surgery: not always indicated or clearcut; higher risk; may fail. 2

Ther Adv Musculoskelet Dis 9 (8), 183-196. 2017 Jun 20) ORTHOPEDICS TODAY, MAY 2016 What is Prolotherapy?

3 Surgery has historically been considered the final solu1on for treatment of knee OA, however there are increasing concerns regarding the lack of randomized controlled studies to support this opinion. (Wehling et al. Ther Adv Musculoskelet Dis 9 (8), Jun 20) ORTHOPEDICS TODAY, MAY 2016 What is Prolotherapy? Prolotherapy (short for prolifera:on therapy ), is a method of regenera:ve injec:on treatment designed to s:mulate musculoskeletal healing. 3

Low risk; High success rate; Mul:ple studies over many years prove safety and efficacy; First journal publica:on 1937 using dextrose based formula.

4 Low risk; High success rate; Mul:ple studies over many years prove safety and efficacy; First journal publica:on 1937 using dextrose based formula. Has evolved to include platelet-rich plasma (PRP) and stem cell source formulas. Used for musculoskeletal pain including osteoarthri1s, but also: Connec1ve 1ssue injury (tendini1s/tendonosis, repe11ve strain injuries, ligament sprains); Knee meniscal tears; Low back pain; Neck pain; Whiplash; Scia1ca; Shoulder pain, Rotator cuff tears, tendoni1s/osis; Elbow pain/golfers and Tennis elbow; Ankle and foot pain/plantar fascii1s;; Wrist and finger pain; High hamstring tendinopathy; Iliopsoas tendinopathy; Hypermobility; Sports injuries and other musculoskeletal pain. 11 To understand why Prolotherapy helps osteoarthri:s, first understand connec:ve :ssue healing and the pathophysiology of OA. 4

Basics of Connec1ve Tissue Healing Ligament/tendons (connec1ve

Muscles (RED): good blood flow Tendon/Ligament (WHITE): poor blood

5 Basics of Connec1ve Tissue Healing Ligament/tendons (connec1ve 1ssue) have poor blood supply (as compared to muscles which have good blood flow). Therefore when injured heal slowly and oken incompletely. Muscles (RED): good blood flow Tendon/Ligament (WHITE): poor blood flow 13 KEY POINT: Injury, then incomplete connec:ve :ssue healing, precede the development of OA. Incomplete connec1ve 1ssue healing results in instability/laxity, resul1ng in change of biomechanics/unusual stress on the joint, and eventually osteoarthri1s 5

6 Not a new concept Lancet: : (65): Brandt, et al.: Not surprisingly, ligament damage may result in osteoarthri1s of a joint rendered unstable by the resul1ng laxity. 6

7 Hunter et al*provided longitudinal radiographic evidence over 25 years, to support the hypothesis that first came instability of the trapeziometacarpal joint, which eventually lead to radiographic thumb base osteoarthri1s. Many other examples. *Hunter et al. Trapeziometacarpal subluxa1on predisposes to incident trapeziometacarpal osteoarthri1s (OA): the Framingham study. Osteoarthri1s and Car1lage Volume 13, Issue 11, November 2005, Pages KEY POINT: In most cases, primary pain origin is unresolved connec1ve 1ssue injury/weakness/ instability, rather than OA itself. OA is a finding on imaging which may or may not be causing pain. Gore DR, Sepic SB, Gardner GM. Roentgenographic findings of the cervical spine in asymptoma1c people. Spine Jul 1;11(6):521-4; and mul1ple other studies. HOW DOES PROLOTHERAPY HELP? Prolotherapy tricks body to start healing again; it raises growth factor levels or effec1veness to promote 1ssue repair or growth to complete a connec1ve 1ssue healing cycle which was incomplete or prematurely aborted (as in repe11ve strain)*. *Reeves KD. Prolotherapy: Basic Science, Clinical Studies, and Technique. In Lennard TA (Ed) Pain Procedures in Clinical Prac1ce 2 nd Ed. Philadelphia, Hanley and Belfus. 2000:

Healing of connec1ve 1ssue improves or resolves pain, as

And if horse already out of barn and OA present, studies

(12.5% to 15%) and/ or saline, and some1mes sarapin or

Platelet-rich plasma ( PRP ) (since early 2000 s):

8 Healing of connec1ve 1ssue improves or resolves pain, as well as biomechanics, prevents further OA. And if horse already out of barn and OA present, studies show prolotherapy has poten1al to regenerate car1lage (to be discussed) PROLOTHERAPY FORMULAS: 1. Tradi(onal or Dextrose (since 1937): Hypertonic dextrose (12.5% to 15%) and/ or saline, and some1mes sarapin or other natural substances, mixed with a local anesthe1c. 2. Platelet-rich plasma ( PRP ) (since early 2000 s): Autologous blood centrifuged, concentrated platelets removed and used as Prolotherapy formula. 8

9 3. Biocellular (Stem cell-rich) Prolotherapy (last 10 years): autologous adult stem cell sources (adipose/fat or bone marrow). Adult stem cells: You are born with them, depleted over 1me. Found throughout the body; par1ally differen1ated only. Used to replenish dying cells and regenerate damaged 1ssues. MAJOR SITES OF MESENCHYMAL STEM CELLS ( MSC ): BONE MARROW and ADIPOSE TISSUE 9

Fat abundant in the body and located just about everywhere at sites exposed to injury. So wherever/whenever the body gets injured, stem cells are nearby.

10 Fat abundant in the body and located just about everywhere at sites exposed to injury. So wherever/whenever the body gets injured, stem cells are nearby. *As may as mes MSCs in adipose as in bone marrow. *Adipose also retains its regenera1ve ability bemer than bone marrow as people age. VERY Brief Review of medical literature regarding Prolotherapy for OA Tradi1onal (dextrose) Prolotherapy 10

CASE SERIES, PATIENTS SYMPTOMATIC, GRADE IV OA. BLINDED ARTHROSCOPIC EVALUATION BEFORE AND AFTER TREATMENT. FOUR TO SIX MONTHLY 10 ML INTRAARTICULAR 12.5% DEXTROSE INJECTIONS.

11 CASE SERIES, PATIENTS SYMPTOMATIC, GRADE IV OA. BLINDED ARTHROSCOPIC EVALUATION BEFORE AND AFTER TREATMENT. FOUR TO SIX MONTHLY 10 ML INTRAARTICULAR 12.5% DEXTROSE INJECTIONS. RESULTS: Posi:ve clinical and chondrogenic effects, sugges:ng disease-modifica:on. WOMAC scores increased 13 points (last follow-up 8 months average) Visual car1lage growth assessment by readers masked to pre/ post status. Post treatment showed car1lage growth compared to pretreatment with arthroscopically collected post treatment biopsy specimens showed metabolically ac1ve car1lage growth. LITERATURE REVIEW. Knee OA; Chondromalacea patella/patellafemoral syndrome, Carometacarpal joint OA studies reviewed. CONCLUDED: Prolotherapy can be considered a first-line conserva(ve method for osteoarthri(s. 11

Therefore conclusion is dextrose for the long term seems to be more advantageous.

12 CONCLUSION: Cor1costeroid bewer at one month, both treatments were comparable at 2 months, but at 6 months much bewer for dextrose. Therefore conclusion is dextrose for the long term seems to be more advantageous. Because of the sa:sfactory pain relief and restoring of func:on, we would prefer dextrose prolotherapy for the treatment of pa:ents with OA. PLATELET RICH PLASMA (PRP) FEBRUARY

13 CONCLUSIONS PRP safe and provides quantifiable benefits for pain relief and functional improvement. No adverse events reported. After 1 year WOMAC scores: Treatment group improved by 78%; Placebo control group improved 7%. Other joints affected with OA may also benefit from this treatment. CONCLUSIONS PRP injec1ons reduced pain more effec1vely than did placebo injec1ons in OA of the knee. PRP superior when compared with hyaluronic acid injec1ons. Func1on improved significantly compared with controls. 13

JUNE 2016 CONCLUSIONS PRP demonstrated efficacy as a treatment for OA, in a number of studies, with a very low rate of adverse events and side effects, compared with surgery. 44 y.

14 JUNE 2016 CONCLUSIONS PRP demonstrated efficacy as a treatment for OA, in a number of studies, with a very low rate of adverse events and side effects, compared with surgery. 44 y.. Woman with shoulder pain/dysfunc1on with no improvement aker 6 weeks therapeu1c ultrasound, PT, and NSAIDS. PRP was injected in the subacromial area 3 1mes at 2 week intervals. She was asymptoma1c at week 6 and followup at 1 year showed xray evidence of resolu1on of calcific tendoni1s. She also had full range of mo1on, had resumed all her ac1vi1es and was pain free. 14

15 10/10/17 BIOCELLULAR (STEM CELL-RICH) PROLOTHERAPY Alderman-Alexander Protocol Journal of Prolotherapy, Aug

16 Volume 16, 2016-Issue 4 Conclusion: There is robust clinical evidence that MSC s have significant poten:al for the regenera:on of hyaline ar:cular car:lage in pa:ents. Pa1ent with MRI proven knee meniscus tear treated with autologous adipose. Post MRI shows resolu1on of tear. PRETREATMENT 3 MONTHS AFTER TREATMENT 16

No surgical treatment for chondromalacia patellae. First human report of a successful anterior knee pain reduc1on awributed to probable car1lage restora1on by autologous adipose derived stem cells.

17 No surgical treatment for chondromalacia patellae. First human report of a successful anterior knee pain reduc1on awributed to probable car1lage restora1on by autologous adipose derived stem cells. Three pa1ents. All three experienced improvement at three months 80-90%, and un1l last followup at one year. NOTE ON THE KNEE FAT PAD The fat pad is believed to be the site of regenera1ve MSC s used for repair whn the knee is injured, as well as providing padding. (Hindle, et al. Stem Cells Interna1onal 2015). Age related fat pad deple1on is associated with anterior knee pain and the development of osteoarthri1s. There has been found to be a strong correla:on between condi:on of a pa:ent s fat pad and his/her pain and osteoarthri:s progression. (Ruhdorfer et al. Osteoarthri1s and Car1lage. 2017). The fat pad can be replenished during a Biocellular (adipose derived) Prolotherapy treatment. 17

Typical medical treatments may not resolve the pain, and surgery is not always indicated

18 CONCLUSION Osteoarthri1s and chronic musculoskeletal pain is a huge problem in the US, and a common medical complaint. Typical medical treatments may not resolve the pain, and surgery is not always indicated and has risks. Prolotherapy Regenera1ve Medicine is a low risk regenera1ve injec1on treatment, with a high success rate, supported by evidence based studies. 18

Ultrasound From Elbow to Finger Tip. Dr Mark Roger Consultant Radiologist

Ultrasound From Elbow to Finger Tip Dr Mark Roger Consultant Radiologist Fast Cheap Dynamic real >me Painless Radia>on free No tunnels Direct pa>ent interac>on/history/examina>on Two sides for comparison