1. Ken Mautner, MD Emory Sports Medicine Center
Point: Counterpoint Exercise vs Intervention for Recalcitrant Tendinopathy
Ken Mautner, MD
Emory Sports Medicine Center

3. The Continuum of Tendinopathy
Harmon K G , and Rao A L Hematology 2013;2013:
©2013 by American Society of Hematology

4. 20-25% do not get better with consesrvative tx- PT, etc
What to do with them ??
Patella tendon even worse?
Insertional achilles/ HS tendon ?

5. 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

6. 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

7. “There is strong evidence that PRP injections are not efficacious in the management of chronic lateral elbow tendinopathy”
BJSM, Feb 2014
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”

9. “God heals, and the doctor takes the fees”
“The art of medicine involves amusing the patient while nature takes it course”
“God heals, and the doctor takes the fees”
Both cynical….

10. Intervention for Tendinopathy
Dexamethasone
Rehabilitation
Lidocaine
Thrombin pH ??
Marcaine
Cytokines ??
Plt
Concentr.
Intervention for Tendinopathy
Dextrose
CaCL
RBC’s
WBC’s
ABX analogy
Needle
ACP
Plt lysate
Orthokine
Autologous Blood
Ropivicaine

11. Corticosteroids Injections for Tendinopathy ?

12. Lancet, 2010

13. Corticosteroid Injections
Lancet, 2010

14. JAMA, 2013
Corticosteroid injection resulted in lower complete recovery or much improvement at 1 year vs placebo injection (83% vs 96%, respectively; P=.01) and greater 1-year recurrence
The physiotherapy and no physiotherapy groups did not differ on 1-year ratings of complete recovery or much improvement (91% vs 88%, respectively; RR, 1.04 [99% CI, ]; P=.56) or recurrence (29% vs 38%)
Similar patterns were found at 26 weeks, with lower complete recovery or much improvement after corticosteroid injection vs placebo injection (55% vs 85%, respectively; RR, 0.79 [99% CI, ]; P.001)
No difference between the physiotherapy and no physiotherapy groups (71% vs69%, respectively; RR, 1.22 [99% CI, ]; P=.84).
At 4 weeks:
significant interaction between corticosteroid injection and physiotherapy (P=.01),
patients receiving the placebo injection plus physiotherapy had greater complete recovery or much improvement vs no physiotherapy (39% vs 10%, respectively; P=.004).
However, there was no difference between patients receiving the corticosteroid injection plus physiotherapy vs corticosteroid alone (68% vs 71%, respectively; RR, 0.95 [99% CI, ]; P=.57).

15. Physiotherapy did not result in any significant differences .
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 .
Corticosteroid injection resulted in lower complete recovery or much improvement at 1 year vs placebo injection (83% vs 96%, respectively; P=.01) and greater 1-year recurrence
The physiotherapy and no physiotherapy groups did not differ on 1-year ratings of complete recovery or much improvement (91% vs 88%, respectively; RR, 1.04 [99% CI, ]; P=.56) or recurrence (29% vs 38%)
Similar patterns were found at 26 weeks, with lower complete recovery or much improvement after corticosteroid injection vs placebo injection (55% vs 85%, respectively; RR, 0.79 [99% CI, ]; P.001)
No difference between the physiotherapy and no physiotherapy groups (71% vs69%, respectively; RR, 1.22 [99% CI, ]; P=.84).
At 4 weeks:
significant interaction between corticosteroid injection and physiotherapy (P=.01),
patients receiving the placebo injection plus physiotherapy had greater complete recovery or much improvement vs no physiotherapy (39% vs 10%, respectively; P=.004).
However, there was no difference between patients receiving the corticosteroid injection plus physiotherapy vs corticosteroid alone (68% vs 71%, respectively; RR, 0.95 [99% CI, ]; P=.57).

16. Interventional guided treatment for calcific tendinopathy of the shoulder?

17. Rotator Cuff Calcific Tendinopathy
Intratendinous calcification
Hydroxyapetite crystal
Supraspinatus (>50%) > Infraspinatus > Subscapularis
Uncertain Etiology
Degenerative
Reactive
Females > males
Age most common
Seen on % of radiographs
Speed et al, 1999 NEJM

18. Calcific Tendinopathy (RTC)
Process may be blocked

19. Studies
Several non-controlled studies from showing good – excellent results with US guided aspiration and lavage
60-74% success rate from published studies

20. 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)

21. 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

22. Shoulder Function Scores (Constant)
Graphs illustrate evolution of (a) Constant and (b) VAS scores in control subjects and patients with rotator cuff calcific tendonitis; 235 shoulders were treated, and 68 shoulders were not treated. Data are mean scores ± standard deviations. Significant differences (∗) between treated and nontreated patients are illustrated. (See also Table 3.)‏
Scores 1 mo- 73.2
Scores 1 yr
Serafini G et al. Radiology 2009;252:

23. VAS scores VAS 1 mo- 4.8 VAS 1 yr- 2.7
Graphs illustrate evolution of (a) Constant and (b) VAS scores in control subjects and patients with rotator cuff calcific tendonitis; 235 shoulders were treated, and 68 shoulders were not treated. Data are mean scores ± standard deviations. Significant differences (∗) between treated and nontreated patients are illustrated. (See also Table 3.)‏
VAS 1 mo- 4.8
VAS 1 yr
Serafini G et al. Radiology 2009;252:

24. Arthroscopic removal (20) vs PNT/aspiration (16) vs Control (17)
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

25. Is Rehabilitation Effective for Tendinopathy?
Need another stu

26. 20 studies with 625 patients included CONCLUSIONS:
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”
Not arguing against effectiveness or eccentrics- but healing may not be the end result…..

27. NEED ANOTHER STUDY HERE

28. 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”

29. Does needling a tendon lead to healing?

30. 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

31. COULD USE MORE DATA HERE

32. Early literature on ultrasound guided needle tenotomy for lateral epicondylosis
McShane et al, Journal of Ultrasound Med. 2006
Ultrasound guided PNT with steroid for chronic lat. epicondylitis
Failed conservative tx
58 pts-- avg f/u 28 mo.
80 % Good or Excellent Outcome
85% would refer friend or family for procedure
McShane et al, Journal of Ultrasound Med 2008
Ultrasound guided PNT without steroid for chronic lat. Epicondylitis
Failed conservative tx
57 pts --avg f/u 22 mo.
92% Good or Excellent Outcome
90% would refer friend or close relative for procedure

33. 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

34. 13 RCT included in the study
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

37. 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

38. First double blind, placebo controlled, RCT on PRP
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 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

39. AJSM, 2011
Type I and II Represent normal/ organized tissue- 1 increased most, 2 a little, 3 and 4 decreased.
Types 3 and 4 disorganized tissue

40. Eccentrics done early (started at 2 wks) Both groups improved
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?

41. RCT-- ABI(n= 70) vs PRP (n=80) 2 injections done 1 month apart
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

42. Double blind RCT with 1 year follow up of 100 pts
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)

43. AJSM, March 2011

44. 46 patients
RCT- PRP vs CSI to lateral epicondyle

45. 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
UTCOMES
1. PRTEE Pain score
Reduction at 3 months in all 3 groups with no statistically significant difference between the groups;
At 1 month glucocorticoid reduced pain more effectively than did both saline and PRP
2. PRTEE Disability score
At 1 month glucocorticoid was superior to saline and PRP
At 3 months no difference
3. US eval (tendon thickness and color doppler)
Glucocorticoid was more effective than PRP and saline in reducing color Doppler activity and tendon thickness
4. Pain associated with INJXN
PRP = 9 > Saline = 7 > CSI = 6
Main Outcome:
Neither injection of PRP nor glucocorticoid was superior to saline with regard to pain reduction in LE at 3 months

46. Comparison of studies
Krogh
PRP
CSI
CSI
PRP
The regeneration of tissue is a process that last more than 3 months
Results of PRP can not be adequately measured with only 3 months follow-up

47. Comparison of studies
Krogh
PRP
CSI
CSI
Ferrero
PRP
The regeneration of tissue is a process that last more than 3 months
Results of PRP can not be adequately measured with only 3 months follow-up

48. Is it the Needle?
AJSM, 2013

51. Measured results using Shoulder Pain and Disability Index
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

52. Greater than 6 months of pain (avg 36 months)
PMR journal, 2013
Pts age (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
PRP done under US guidance
Patients either sent to PT or instructed to do HEP after treatment
Strengthening
CFM
Modalities

53. Distribution of Tendons
Lateral Epicondyle
Patella Tendon
Achilles
Rotator Cuff
Hamstring 17
Gluteus Medius 16
Medial Epicondyle 11
Plantar Fascia 9
13 other tendons <5 each

54. Overall Improvement 82% reported moderate to complete improvement
65% mod-complete in non tendon group
82% reported moderate to complete improvement
– 50%- 100% relief of symptoms
70 % reported mostly to complete improvement
% relief of symptoms
NO difference in outcomes in those who did PT vs No Therapy after treatment.

55. RCT with 43 patients randomized to 1 of 3 groups
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

57. 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

58. 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

59. Thank You

60. Outline Need for treatments beyond PT/ rehab No cortisone
History of tenotomy/ prolotherapy
Basic science of how it works
Level 1 data- dbrct showing positive benefits and those that do not!!!!