Henning Langberg. Professor at the Institute of Health University of Copenhagen, Copenhagen, Denmark

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RCT in PRPs. From theory to practice

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5th MuscleTech Network Workshop ”Research on Muscle and Tendon Injuries: from scientific evidence to clinical practise” Anders Boesen, MD , PhD. Student Institut of Sports Medicine Copenhagen H:S Bispebjerg Hospital Team Doctor F.C Copenhagen

Barcelona 14th and 15th October 2013

High Volume Injection (HVI) in Achilles Tendinopathy

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High Volume Injection

Possible treatment option for Tendinopathy???

Platelet-rich Plasma or High Volume injection (HVI) in Achilles Tendinopathy (RCT, double blinded).

è ç

ACP (4mls)

High Volume Injection 10 mls Marcain 0,5 % + 1/3 ml. Depomedrol 40 mg/ml + 40 mls Saline

+

12 wk Eccentric traning

Dr. Otto Chan, London SportsCare, London Independent Hospital

December 2011 London SportsCare, London Independent Hospital

High Volume Injection:

�  10 mls Marcaine 2,5 mg/ml �  ∼ 1/3 ml Depomedrol (40mg/ml) �  40 mls Saline

What is High Volume Injection?

High Volume Injection steps:

Step 1: Ultrasound Diagnostic

High Volume Injection steps:

Step 2: Material (whats needed?)

•  Marcaine, Depomedrol and Saline •  10 mls. Syringes (5 pieces) •  Tube and needle (green) •  Gloves •  Desinfection (klorhexidin)

High Volume Injection steps:

Step 3: Injection Procedure

High Volume Injection:

Step 3: Injection Procedure

High Volume Injection:

Step 3: Injection Procedure

High Volume Injection:

Step 3: Injection Procedure

High Volume Injection:

When should you use HVI?

High Volume Injection steps: Step 4: Rehab Program (Otto Chan group)

Day 1-3: Rest from sport, jumping, running, long walk Day 4: Fitness work (3 x 40 minute sessions/week)- Swimming, cycling or rowing Day 6: Start Alfredson 12 wk eccentric training protocol- 3x15 calf drops-knee bent and 3x15 calf drops-knee straight (Twice per day) Start with bodyweight, add 5kg increments if there is no discomfort. Mild to moderate pain during is acceptable (VAS <4/10), but should settle quickly. Day 10: Commence stretch-shorten cycle/impact activity Start with 5-10 minutes of sport, at modified intensity (ie no sprinting or maximal jumps). Then increase by 5-10 minutes per week based on this pain monitoring system and gradually increase intensity.

High Volume Injection: Step 4: Rehab Program (Modified by our Group)

Day 1-5: Rest from sport, jumping, running, long walk Day 6: Start Alfredson 12 wk eccentric training protocol (Twice per day) Start with bodyweight, add 5kg increments if there is no discomfort. Mild to moderate pain during is acceptable (VAS <4/10), but should settle quickly. Day 7: Fitness work (3 x 20-30 minute sessions/week) - Swimming, light cycling or rowing. Day 28 Introducing jogging on flat surface progressing to trampoline. If no pain start running 5-10 minutes, flat surface, slow/steady pace. Increase by 5-10 minutes per week. No more than every 2nd to 3rd day. Only progress if symptoms are stable. When running 30 minutes, progressively commence sport.

è Should be monitored by a Physiotherapist

High Volume Injection:

•  Complications? -  No infections or skin complication seen

-  Relapse: Approx. 15-20 % in the Tendon Clinic out of 150 Achilles and 75 Patella Tendons. -  One case of (1/150 Achilles) partiel rupture 3 1/2 months after HVI during high intensity running on sand. -  One case of (1/150 Achilles) total rupture 3 1/2 months after HVI (startet playing football and trained full after only 2 wks)

1) High volume image guided injections in chronic Achilles tendinopathy. Chan O et al, Disabil Rehabil. 2008;30(20-22):1697-708. 21 patients (no control group) Conclusion: HVI significantly reduces pain (VAS) and improves function (VISA-A) in the short (4 weeks) - and long-term (6 month). 2) High volume ultrasound guided injections at the interface between the patellar tendon and Hoffa's body are effective in chronic patellar tendinopathy. Crisp T et al, Disabil Rehabil. 2008;30(20-22):1625-34. 9 patients (no control group) Conclusion: HVI significantly reduces pain (VAS) and improves function (VISA-P) in the short (2 weeks) - and long-term (9 month). 3) The short-term effects of high volume image guided injections in resistant non-insertional Achilles tendinopathy. Humphrey J et al, Sci Med Sport. 2010 May;13(3):295-8. 11 patients (no control group) Conclusion: HVI improved symptoms (VAS) and function (VISA-A), reduce neovascularisation, and decrease maximal tendon thickness at short-term follow-up (3 weeks).

1) High volume image guided injections in chronic Achilles tendinopathy. Chan O et al, Disabil Rehabil. 2008;30(20-22):1697-708. 21 patients (no control group) Conclusion: HVI significantly reduces pain (VAS) and improves function (VISA-A) in the short (4 weeks) - and long-term (6 month). 3) High volume ultrasound guided injections at the interface between the patellar tendon and Hoffa's body are effective in chronic patellar tendinopathy. Crisp T et al, Disabil Rehabil. 2008;30(20-22):1625-34. 9 patients (no control group) Conclusion: HVI significantly reduces pain (VAS) and improves function (VISA-P) in the short (2 weeks) - and long-term (9 month). 4) The short-term effects of high volume image guided injections in resistant non-insertional Achilles tendinopathy. Humphrey J et al, Sci Med Sport. 2010 May;13(3):295-8. 11 patients (no control group) Conclusion: HVI improved symptoms (VAS) and function (VISA-A), reduce neovascularisation, and decrease maximal tendon thickness at short-term follow-up (3 weeks).

Platelet-rich Plasma or High Volume injection (HVI) in Achilles Tendinopathy (RCT, double blinded).

è ç

ACP (4mls)

High Volume Injection 10 mls Marcain 0,5 % + 1/3 ml. Depomedrol 40 mg/ml + 40 mls Saline

+

12 wk Eccentric traning

Platelet-Rich Plasma or High Volume injections in Achilles tendinopathy (RCT, double blinded)

Design: •  Subjects: 60 randomized healthy male patients age 25-60 years with unilateral Achilles tendinopathy > 3 months. (no steroid inj.<6 month)

•  12 weeks eccentric training (all patients).

•  Randomized: ACP (N=20), HVI (N=20) or Placebo (N=20) – all included.

•  Follow-up after 6 weeks, 3 month and 6 months (12 month). – lost to follow-up (one in each group)

Review of litt

PRP is simple

These cytokines play important roles in cell proliferation, chemotaxis, cell differentiation, and angiogenesis

Review of litt

The symphony of GF of tendon healing

Challenges in use of PRP

•  Timing of the various growth factors •  Readiness of the tissue •  Local injection – right spot •  Other stimuli – loading ?

First 6 month study design (n= 3 X 19 patients):

                 2  wks

Diagnosed Achilles tendinopathy clinically and with ultrasound

Blodsample (10ml) X X X X

ACP (n=19) (4ml) X X X X

HVI (n=19) X (after first HVI injection the groups revieve only placebo)

Placebo (n=19) X

Ultrasound X X X X X X

VISA-A score X X X X X

VAS score X X X X X X

Heel-rise test X X X X

Start eccentric train. X

End eccentric train. X (performed 3 times/wk from week 12)

                 2  wks                  2  wks                  6  wks                  12  wks

High Volume Injection:

ACP (Artrex system) procedure:

1)  Whole Blood is taken out (10-12 mls). 2) Blood centrifugation (spinning) 3) Separation of the ACP (4 mls)

Alfredson 12 wk Eccentric Program: 15 rep. X 3 bended knee 15 rep. X 3 straigth knee è Twice a day 12 – 24 wk: 3 times a week

All participants performed eccentric training

• VISA-A (function) and VAS score (pain symptoms) • Range of motion and heel-rise test (MuscleLab). • Ultrasound (gray-scale and Doppler) • Analyse ACP: Platelets concentration and growth factors (PDGF, TGF-ß, IGF-1, PDEGF, PDAF, PF-4, EGF and VEGF)

Measurements (6 wk, 3 month and 6 month):

Measure the exact heel hight and number of reps (total workload)

- Use it during rehab after achilles rupture

Results VISA-A 6 wk., 3 month and 6 month

Significant increase in all groups after 6,12 and 24 weeks from baseline Significant difference between HVI vs ACP and Placebo (6wk and 3 month) Significant difference ACP/HVI vs Plc (24 wk.)

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Results VAS 6 wk., 3 month and 12 month

Significant increase in all groups after 6 and 12 weeks from baseline Significant increase between HVI vs ACP and Placebo (6wk) Significant increase between HVI/ACP vs Placebo (12 wk and 24 wk)

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Results Ultrasound 6 wk., 3 month and 6 month

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Significant increase in HVI and ACP group in all follow-ups vs baseline Significant increase between HVI vs ACP and Placebo (6wk and 12 wk) Significant increase between ACP and Placebo (12 wk) Significant increase between ACP/HVI vs Placebo (24 wk)

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Results Heel-rise 6 wk., 3 month and 6 month

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- Significant increase in HVI, ACP and Placebo group in all follow-ups compared to baseline. - No differences between groups

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Total  work  load  (heel-­‐rise  test)

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After  6  weeks After  3  month After  6  month

Chances  in  total  w

ork  load  from

 baseline  (Jo

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HVIACPPlacebo

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• VISA-A score (functional score): All groups improved at 6 wk, 12 wk and 24 wk follow-up! 6 wk and 3 month- Significant differences (P<0.01) between HVI vs. ACP and Placebo!! 6 month- Significant differences (P<0.01) between HVI and ACP vs. Placebo!! • VAS score (pain score): All groups improved at 6 wk, 12 wk and 24 wk follow-up! 6 wk and 3 month- Significant differences (P<0.01) between HVI vs. ACP and Placebo!! 6 month- Significant differences (P<0.05) between HVI and ACP vs. Placebo!! • Ultrasound (gray-scale): All groups improved at 6 wk, 12 wk and 24 wk follow-up! 6 wk and 3 month- Significant differences (P<0.01) between HVI vs. ACP and Placebo!! 6 month- Significant differences (P<0.05) between HVI and ACP vs. Placebo!!

Summarize results ( 6 month follow-up)

Conclusion •  HVI or ACP in combination with eccentric training seems more effective than eccentric training, per se! - Reducing pain symptoms, - Improving activity level and - Reducing tendon thickness ⇒ HVI appears more effective than ACP in the short-term (3 month).

Started up a new pilot project (6 wk, 3 month and 6 month follow-up): 12 patients HVI (+Depomedrol) vs. 12 patients HVI (÷ Depomedrol)

è See how how much effect corticosteroid has compared to volume effect ???

Case 1 •  A young talented player

with symptoms in the patella tendon (on and off pain during warm up or after training, better during activity) during the preseason training

•  what to do? •  continue training? adjust

training? add treatment?

Case 2 •  A very important

player during season experience increasing symptoms (pain and stiffness in the morning) in the Patellar Tendon weeks before an important match

•  What to do ??

Case 3

•  One of you players experiences sudden unset of pain in the Insertional Achilles tendon during training but only during high loading.

•  What to do ?

Thanks to: Morten Boesen Rudi Hansen Otto Chan Peter Malliaras Michael Kjaer Henning Langberg (PhD. Supervisor)

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