An overview and a few things to know · •Treatment protocol recommended –machine/impulses 2,500...

Nicola Maffulli MD, MS, PhD, FRCP, FRCS (Orth)

Extracorporeal shock wave therapyAn overview and a few things to know

Muscles, ligamentsand tendons

- Bone always heals- Cartilage never heals- Tendons, muscles and ligaments is where we can make a difference

JB King FRCS, 1987

What can shock wave treatment do EXPERIMENTALLY ?

What can shock wave treatment do CLINICALLY ?

Why shock wave treatment ?

FAILED

HEALING

RESPONSE

08/29

There is no RCT base for the use of NSAIDs•

09/29

There is no RCT base for the use of corticosteroid

injections•

.

CHALLENGE: TENDON HEALING

There is RCT base for the use of platelet-rich plasma

injections, but they do not work in a predictable fashion•

There is RCT base for the use of Polidocanol injections,

but only in Scandinavia

•

There is no RCT base for the use of surgery•

Shockwave Therapy for Musculoskeletal and Soft Tissues

Used to treat:

• Achilles tendinopathy• Plantar fasciitis• Tennis elbow• Calcific tendinopathy of the shoulder• Greater trochanter pain syndrome• Patellar tendinopathy• Hamstring Injury• Back pain

SWT in several disciplines

Review (2014) suggesting ESWT may replace surgery. Important to obtain correct diagnosis

Follow-Up: (minimum 3 months) before considering surgery – longer follow-needed to

see true efficacy - ASSERT

Levels of Evidence: Level 1 etc. Evidence SWT V Placebo

Radial extracorporeal shock wave therapy proved significantly superior to placebo. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo

There is at least one positive RCT for almost any

conceivable tendinopathy

The efficacy of ESWT is clearlysupported by cumulative data

88.5% (23/26) of all RCTs onrESWT and 81.5% (66/81) of allRCTs on fESWT in PEDro hadpositive outcome

Plantar fasciitisAchilles tendinopathy

Calcifying tendinitis of the shoulderTennis elbow

Hamstring tendinopathyGreater trochanter pain syndrome

Jumper kneeMedial tibial stress snyndrome

etc.

Rehabilitation: Evidence for SWT in Musculoskeletal and Soft Tissues plus

rehabilitation programmes

CONCLUSION: At 4-month follow-up:eccentric loading alone was less effective compared with combination of eccentric loading & repetitive low-energy shock-wave treatment

And yet……

NICE (Policies and guidelines for GPs, local government, public health professionals and members of the public on Health and Care Excellence) state:

“ESWT raises no major safety concerns however the current evidence for ESWT in the majority of indications is conflicting, as such ESWT should only be used where there are special arrangements for clinical governance and audit”

Level 1 evidence existsDespite this SWT not gained NICE acceptance

So many studies using different treatment protocols; patient groups; Outcome Scores led to the development of an online platform to assess the effectiveness of ESWT for soft tissue injuries ASSERT launched in 2012 to present day

- standardised validated treatment protocol- validated Outcome Scores - chronic injuries (failed 2 or more conservative treatments)- correct diagnosis - real world/pragmatic - long term follow-up

ASSERT

Primary aim: to determine the effectiveness of ESWT in patients suffering from refractory plantar fasciopathy, tennis elbow, calcific shoulder tendinopathy, Achilles tendinopathy, greater trochanter pain syndrome, patellar tendinopathy in both the short and long term

Protocol

• Standardised:• Recruitment - diagnosis USS/MRI if possible

• Participants representative of population

• Treatment protocol recommended – machine/impulses 2,500 per session for 3 sessions, 1 week apart (1.5 bar increasing to 2.5 bar or above). HOWEVER Pragmatic: can change impulses & number of sessions if so recorded in treatment records

• Follow-up schedule

• Outcome measures - Validated

Results for ASSERT 1 - 619 patients

Further data:

ASSERT 2 – 948 recruited

Pathology

0

50

100

150

200

250

1

Trochanteric Bursitis

Calcific TendinopathyShoulder

Tennis Elbow

Patellar Tendinopathy

Achilles Insertional

Achilles Midsubstance

Plantar Fasciitis Insertional

Plantar FasciitisMidsubstance

53%

47%

Gender

Men

Women

Patellar Tendinopathy

ParticipantsAge and Gender

n Age (y)

Number of

previous

treatments

Participants enrolled51 (44 male and 7

female)

39.32 ±

11.571.71 ± 1.02

Participants considered for the

analyses

49 (43 male and 6

female)

39.26 ±

11.701,68 ± 0.97

.

VAS – Significant Baseline and all time Points

53

34

25

21 21

BASELINE 3 MONTHS 6 MONTHS 12 MONTHS 24 MONTHS

VAS for Pain

Higher score betterSignificant – Baseline and 12 and 24 months

4953

6165

76


VISA P

Calcific Tendinopathy of the Shoulder

Participants

n Age (y)Number of previous

treatments

Participants enrolled23 (16 male and 7

female)52.27 ± 20.23 1.60 ± 1.17


analyses

15 (11 male and 4

female)49.00 ± 20.04 1.63 ± 1.06

Table 1. Sample of participants

Vas – Not significant (n=15)

5248

52

16

28


VAS for Pain

Upper Extremity ScoreLower score better (trending towards

significance)

36

22

27 28

10


Upper Extremity Score

Greater Trochanter Pain Syndrome

Greater Trochanter Pain Syndrome


treatments

Participants enrolled 43 (8 male and 35 female) 55.26 ± 14.57 1.93 ± 0.97


analyses40 (7 male and 33 female) 56.35 ± 13.90 2.03 ± 0.90

Sample of participants.

48

32 32

2426


VAS for Pain

Participants (n=40)Higher score better

52

48

52

16

28


Lower Extremity Function Score (LEF)

Tennis Elbow

Tennis ElbowParticipants - Age & Gender


treatments

Participants enrolled and considered for analyses 5952.51 ±

10.33

1.77 ± 1.33

Male 25 50.17 ± 10.21 1.50 ± 1.10

Female 34 54.21 ± 10.23 1.97 ± 1.47

With menopause 18 61.78 ± 6.61 1.76 ± 1.03

Without menopause 16 45.13 ± 4.94 2.20 ± 1.86

Sample of participants.

Tennis ElbowVas Pain – Significant all time points

62

31

2017

15

BASELINE 3MTHS 6MTHS 12MTHS 24MTHS

Patient Rated Tennis Elbow Evaluation (PRTEE)

Score measures pain & function. Higher score worse the condition

Reduction in score (improvement condition) – significant at Baseline & all follow-up

52

28 2621

13


PRTEE

Achilles Tendinopathy InsertionalResults

Insertional Achilles TendinopathyParticipants Age & Gender

Age (y)Number of previous

treatments

Means (range) Means (range)

Participants enrolled 82 53.18 (20-81) 1.72 (0-6)

Male 52 52.65 (20-78) 1.69 (0-6)

Female 30 54.03 (28-81) 1.77 (0-4)

Participants considered for the analyses 80 53.41 (20-81) 1.68 (0-6)

Male 51 52.91 (20-78) 1.64 (0-6)

Female 29 54.21 (28-81) 1.77 (0-4)

Significant between Baseline and all follow-up

59

33 32

24

18


VAS for Pain

VISA-AMeasures pain, function & sporting activity. Higher score better

the patient If no sport max score = 70 (last 30 score = sporting activity)

Significantly increased from baseline to 12 & baseline & 24 (3 vs 24; 6 vs 24). Wait until 12 and 24 months to report optimum improvement

42

53 54

6672


VISA A

Midsubstance Achilles Tendinopathy Results

Participants

nAge (y)

Number of

previous

treatments

Mean (range) Mean (range)

Participants enrolled 94 53.91 (23-77) 1.65 (0-4)

Male 52 55.28 (23-77) 1.64 (0-4)

Female 42 52.34 (32-76) 1.67 (0-4)

With menopause 25 58.16 (51-76) 1.57 (0-4)

Without

menopause17 43.25 (32-50) 1.80 (0-4)


analyses84 54.30 (23-77) 1.66 (0-4)

Male 45 55.56 (23-77) 1.64 (0-4)

Female 39 52.87 (32-76) 1.68 (0-4)

With menopause 24 58.33 (51-76) 1.60 (0-4)

Without 15 43.50 (32-50) 1.79 (0-4)

Significant at all time points

50

20 19

14

4


VAS for Pain

Significant at all time points

47

6871

8389


VISA A

Plantar Fasciitis

InsertionalParticipants – Age & Gender


treatments

Participants enrolled 211 48.09 ± 17.86 2.47 ± 1.54

Male 106 45.06 ± 19.82 2.42 ± 1.59

Female 105 51.16 ± 15.13 2.53 ± 1.49

With menopause 61 59.82 ± 6.93 2.45 ± 1.45


Participants considered for the analyses 198 48.17 ± 17.61 2.53 ± 1.52

Male 96 45.48 ± 19.47 2.46 ± 1.60

Female 102 50.95 ± 15.29 2.58 ±1.45

With menopause 58 59.90 ± 7.06 2.54 ± 1.40


VAS – Significant Baseline and all time points

60

31

20

129


VAS for Pain

FFI – Lower score, better conditionSignificant from Baseline and all time points

49

25

18

12

8


Foot Function Index (FFI)

MidsubstanceParticipants – Age & Gender


treatments

Participants enrolled 5653.45 ±

11.871.90 ± 1.37

Male 26

55.24 ±

14.441.26 ± 0.73

Female 30 52.11 ± 9.48 2.50 ± 1.57

Participants considered for the analyses 5253.89 ±

12.11

1.90 ± 1.37

Male

2655.24 ±

14.441.26 ± 0.73

Female 26 52.71 ± 9.80 2.50 ± 1.57

VAS – Significant Baseline and all time points

65

28

2018

11


VAS for Pain

FFI – Lower score, better conditionSignificant from Baseline and all time points

51

26

22 21

7


Foot Function Index - FFI

Future for ESWT

• NICE: difficult to interpret the evidence for SWT because of the diversity of treatment protocols and comparators used, varying reported end points, and inconsistencies in use of local anesthesia and energy type

• SWT community needs to continue to collect data – prove effectiveness consistent manner

• Publish data

Other Applications of Shockwave Therapy

Cellulite Treatment

Wound Healing

Erectile Dysfunction

• Thank you to all the recruiters, participants

• A big thank you to Dr Johnny Padulo for the statistical analysis

• To a bright future – continue to collect data in an even more efficient way for everyone

• ASSERT 2 analysis

If

you

wish

to

know

more …

London 23rd March 2019

… if

you

just

cannot

wait …

WWW.MLTJ.ORG

JOSR-ONLINE.COM

… in

the

end ...

… still a

mountain

to climb...

… but progress is being made

Thank you

An overview and a few things to know · •Treatment protocol recommended –machine/impulses 2,500...

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