Point: Counterpoint Exercise vs Intervention for Recalcitrant Tendinopathy Ken Mautner, MD Emory Sports Medicine Center The Continuum of Tendinopathy Harmon K G , and Rao A L Hematology 2013;2013:620-626 ©2013 by American Society of Hematology 20-25% do not get better with consesrvative tx- PT, etc What to do with them ?? Patella tendon even worse? Insertional achilles/ HS tendon ? Before we get started……. Rehabilitation is the cornerstone of any successful treatment for tendinopathy Eccentric exercise programs have a proven track record to be successful in treatment of tendinosis, especially Achilles tendon There are other modalities that are not going to be discussed here that also have some efficacy in the treatment of tendinosis STM (CFM, Graston, ASTYM) NO patches ECSWT In most cases, interventions should be reserved for tendons that have failed appropriate conservative/ less invasive treatments However …. 20-25% of recalcitrant tendinopathy does not get better with optimal rehabilitation Rigorous program to be compliant Outside of Achilles tendon, results may be even worse Certain body regions seem to do even worse with traditional care: Insertional Achilles tendinosis Proximal Patella tendinosis Proximal HS tendinosis BJSM, Feb 2014 “There is strong evidence that PRP injections are not efficacious in the management of chronic lateral elbow tendinopathy” Arthroscopy, Nov, 2013 ”The current evidence suggests that PRP may be of benefit over standard treatment as a second line intervention…the current evidence is promising but limited” “The art of medicine “God heals, and the involves amusing the doctor takes the patient while nature fees” takes it course” Dexamethasone pH ?? Plt Concentr. ?? Dextrose RBC’s Plt lysate Autologous Blood Ropivicaine Corticosteroids Injections for Tendinopathy ? Lancet, 2010 Corticosteroid Injections Lancet, 2010 JAMA, 2013 JAMA, 2013 Among patients with chronic unilateral lateral epicondylalgia, the use of corticosteroid injection vs placebo injection resulted in worse clinical outcomes after 1 year. Physiotherapy did not result in any significant differences . Interventional guided treatment for calcific tendinopathy of the shoulder? Rotator Cuff Calcific Tendinopathy Intratendinous calcification Hydroxyapetite crystal Supraspinatus (>50%) > Infraspinatus > Subscapularis Uncertain Etiology Degenerative Reactive Females > males Age 30-50 most common Seen on 7.5-20% of radiographs Speed et al, 1999 NEJM Calcific Tendinopathy (RTC) Process may be blocked Studies Several non-controlled studies from 1995-2005 showing good – excellent results with US guided aspiration and lavage 60-74% success rate from published studies American Journal Of Roentgenology, 2007 67 consecutive pts treated and evaluated up till 1 year after treatment 91% of shoulders had substantial or complete improvement 64% with perfect motion 89% complete or near complete resolution of calcifications 44% transient recurrence in symptoms (around 6 wks after procedure) Radiology, 2009 Rotator Cuff Calcific Tendonitis: short term and 10 year outcome after 2 needle US guided percutaneous treatment- non randomized controlled trial 219 treated 68 refused treatment – control group 1 treatment performed with 16g needle and 2 needles Shoulder Function Scores (Constant) Serafini G et al. Radiology 2009;252:157-164 Scores 1 mo- 73.2 Scores 1 yr - 91.7 VAS scores Serafini G et al. Radiology 2009;252:157-164 VAS 1 mo- 4.8 VAS 1 yr- 2.7 Joint Bone Spine, 2009 102 pts 53 did not improve with steroid injection Arthroscopic removal (20) vs PNT/aspiration (16) vs Control (17) At 4 month f/u > 70% improvement PNT 62% vs Scope 65% > 90% improvement PNT-48% vs Scope 8% 2 year f/u Arthroscopy = PNT group >> Control PNT/aspiration equal or better than Scope Is Rehabilitation Effective for Tendinopathy? BJSM, Ocotober, 2012 Systematic review of the relationship between observable structural changes and clinical outcomes following response to therapeutic exercise 20 studies with 625 patients included CONCLUSIONS: “The available literature does not support observable structural changes as an explanation for the response to therapeutic exercise when treated by eccentric exercise training” NEED ANOTHER STUDY HERE Conclusion: “Limited evidence exists to suggest that EE has a positive effect on clinical outcomes such as pain, function, and patient satisfaction/ return to work when compared to various control interventions such as concentric exercises, stretching, splinting, friction, and ultrasound.” “ This review demonstrates a dearth of high quality research in support of the clinical effectiveness of EE over other treatments in the management of tendinopathies. Further adequate powered studies…. Are required” Does needling a tendon lead to healing? Basic science of needling Eliasson et al, 2013, FASEB Needling an unloaded rat Achilles tendon induced same gene expression as early mechanical loading Mechanical loading may heal, at least in part, by micro trauma Dallaudiere et al, 2013, Eur Radiology, RCT on rat model of PRP vs Serum Had clinically significant improvement in PRP group vs serum group on joint motion, ultrasound appearance, and histology Tendon healing demonstrated as opposed to just clinical pain relief COULD USE MORE DATA HERE Early literature on ultrasound guided needle tenotomy for lateral epicondylosis McShane et al, Journal of Ultrasound Med. 2006 Ultrasound guided PNT with McShane et al, Journal of Ultrasound Med 2008 Ultrasound guided PNT without steroid for chronic lat. epicondylitis steroid for chronic lat. Epicondylitis Failed conservative tx Failed conservative tx 58 pts-- avg f/u 28 mo. 80 % Good or Excellent 57 pts --avg f/u 22 mo. 92% Good or Excellent Outcome Outcome 90% would refer friend or close 85% would refer friend or family for procedure relative for procedure PRP for chronic lateral epicondylosis AJSM, 2006 140 pts evaluated for lateral epicondylosis 20 had refractory pain an avg. of 15 months later 15 in treatment group, 5 in bupivicaine control group Intervention – Injection w/ autologous PRP once into common extensor tendon followed by gradual increase in rehab program through 4 weeks after which full activity allowed Outcome – A 46%, 60% and 81% improvement in VAS pain scores at 1, 2 and 6 months respectively in tx group – 3/5 in bupivicaine group withdrew/ sought other tx – At final F/U (12-38 months) 93% pain free (<10/100 VAS) – No complications, no one got worse British Medical Bulletin, 2014 13 RCT included in the study 886 patients 53.8% with identical PRP protocol Areas of controversy Different comparators Outcome scores FU periods Diverse injection protocols Conclusion: Pooling pain outcomes over time suggest that L+PRP ameliorates pain in the intermediate and long term compared with control interventions Low power, precision Further studies needed Why are we still debating if orthobiologics works? Need to define what we are injecting ? Platelet concentration MSC concentration Leukocyte count RBC +/ RBC – Autologous/ allogenic Need to define the procedure US guidance Needle tenotomy performed ? How many needle passes ? Rehabilitation methods Need to be studied/ validated Immobilization Timing of eccentrics May need to separate out different body parts JAMA, January 13, 2010 First double blind, placebo controlled, RCT on PRP 54 randomized patients age 18 to 70 with chronic (at least 2 mo) achilles tendon pain 2 to 7 cm above calcaneus Either 6cc PRP or Saline was injected with US guidance into achilles AJSM, 2011 tendon Rehab for both groups involved rest and then after 2 weeks, started on 12 week daily (180 repetitions) eccentric exercise program No sports for at least 4 weeks and then only if pain <=3/10 f/u questionnaire at weeks 6,12,24 (6 mo) AJSM, 2011 DISCUSSION Both groups were treated with eccentrics AFTER treatment; NONE treated before treatment Big confounder in study Eccentrics done early (started at 2 wks) Both groups improved Needle? Saline? Placebo? Eccentric Exercises? BJSM, 2011 RCT-- ABI(n= 70) vs PRP (n=80) 2 injections done 1 month apart All patients had FAILED an eccentric loading program and stretching program At 6 mo 66% success rate in PRP group 10% converted to surgery 72%success rate in ABI group 20% converted to surgery AJSM, Feb, 2010 Double blind RCT with 1 year follow up of 100 pts No ultrasound guidance was used Success defined as >25% reduction in VAS or DASH score RESULTS At 1 yr, 49% of CSI group and 73% in PRP group were successful (p<.001) AJSM, March 2011 46 patients RCT- PRP vs CSI to lateral epicondyle AJSM, 2013 METHODS N = 60 PRP vs Saline vs glucocorticoid (+ Lidocaine) Primary end point - change in pain using Patient-Rated Tennis Elbow Evaluation (PRTEE) at 3 months Secondary Outcomes - were ultrasonographic changes in tendon thickness and color Doppler activity Main Outcome: Neither injection of PRP nor glucocorticoid was superior to saline with regard to pain reduction in LE at 3 months Comparison of studies K r o g h PRP CSI CSI Ferrero PRP Results of PRP can not be adequately measured with only 3 months follow-up Is it the Needle? AJSM, 2013 Clinical Rehabilitation, 2012 2 PNT vs 2 PRP injections under US guidance for RTC tendinosis or small, partial tear Measured results using Shoulder Pain and Disability Index Baseline 2wks after 1st injection Right before second injection 2 wks after second injection 3 months 6 months PMR journal, 2013 Pts age 16-70 (avg 48 yrs) Greater than 6 months of pain (avg 36 months) Diagnosed by clinical exam plus MRI or diagnostic US ALL had Failed conventional treatments (not controlled) Medications Bracing Stretching • • • Strengthening CFM Modalities PRP done under US guidance Patients either sent to PT or instructed to do HEP after treatment Distribution of Tendons Lateral Epicondyle 30 Hamstring 17 Patella Tendon 27 Gluteus Medius 16 Achilles Medial Epicondyle 27 Rotator Cuff 11 21 Plantar Fascia 9 13 other tendons <5 each Overall Improvement 82% reported moderate to complete improvement – 50%- 100% relief of symptoms 70 % reported mostly to complete improvement -- 75-100% relief of symptoms NO difference in outcomes in those who did PT vs No Therapy after treatment. BJSM, 2009 RCT with 43 patients randomized to 1 of 3 groups 12 week Eccentric training protocol (15) Prolotherapy with hypertonic glucose/ lidocaine (14) Combination of both EE + Prolo (14) Outcomes looked at Pain Function Stiffness/ limiation of activities Cost Long term efficacy similar in all 3 groups, but ELE combined with prolo gave more rapid improvement in symptoms. Cost effectiveness analysis shows that ELEs was the lowest cost treatment, but when combined with prolotherapy, the cost per additional responder was exceptionally good value for money Take Home points There are a certain percentage of tendons that will not improve with rehabilitation alone Corticosteroids offer only short term improvement in tendinosis and may provide long term detriment Level 1 studies demonstrating lavage/ aspiration of calcific tendinosis of shoulder is a successful intervention Basic science suggests that needling a tendon can lead to a healing response Emerging data that US guided needle tenotomy +/- PRP is successful for recalcitrant tendinopathies Ken.mautner@emory.org