Interventional procedure overview of extracorporeal shockwave therapy for calcific tendinopathy in the shoulder

Systematic review (Cochrane)

Trials were set in Italy, Germany, Austria, Norway, the Netherlands, UK, China, France, Taiwan, Spain, Turkey, and South Korea

Search date: November 2019

n=2,281 (32 trials)

People with rotator cuff disease, with or without calcification

Mean age ranged from 48 to 56 years (in 16 studies); 61% female (in 30 studies)

Study selection criteria for review: RCTs and controlled clinical trials that used quasi-randomised methods to allocate participants, investigating participants with rotator cuff disease with or without calcific deposits. Trials of comparisons of shockwave therapy versus any other intervention were included. Major outcomes were pain relief greater than 30%, mean pain score, function, patient-reported global assessment of treatment success, quality of life, number of participants experiencing adverse events and number of withdrawals due to adverse events.

Patient selection: inclusion criteria or definitions of the included conditions (or both) varied between trials.

Shockwave treatments were heterogeneous across trials and varied in the machines used to generate the shock waves, number and size of energy pulses, and the number of treatment sessions (1 to 6 sessions varying from 7 to 16 days apart).

Twelve trials compared shockwave therapy to placebo, 11 trials compared high-dose shockwave therapy (0.2 mJ/mmN to 0.4 mJ/mmN and above) to low-dose shockwave therapy. Single trials compared shockwave therapy to ultrasound-guided glucocorticoid needling, ultrasound-guided hyaluronic acid injection, transcutaneous electric nerve stimulation, no treatment or exercise; dual session shockwave therapy to single session therapy; and different delivery methods of shockwave therapy. Of the 32 trials, 7 specified that radial shockwave therapy was used.

For most studies, follow up was 3 to 12 months; 1 had a mean follow up of 23 months

Two studies were funded by manufacturers of shockwave machines, 7 studies were funded by grants from research foundations or universities, 3 studies were provided with the shockwave machines, 9 studies explicitly reported they received no funding while 13 studies did not report either way.

RCT

Norway

2012 to 2014

n=143 (69 radial ESWT and supervised exercises, 74 sham radial ESWT and supervised exercises)

Patients with subacromial pain syndrome lasting at least 3 months, with or without calcification in the rotator cuff

Active radial ESWT: mean age=47.6 years, 54% (37/69) female

Sham radial ESWT: mean age=46.0 years, 55% (41/74) female

Inclusion criteria: patients aged 25 to 70 years with subacromial pain lasting at least 3 months, dysfunction or pain on abduction, normal passive glenohumeral range of motion, pain on at least 1 of 2 isometric tests (abduction or external rotation), and a positive Hawkins impingement sign.

Exclusion criteria: previous surgery on the affected shoulder, instability, rheumatoid arthritis, full-thickness tear of the rotator cuff, cervical radiculopathy, infection, inability to complete questionnaires or follow treatment plan, contraindications to shockwave therapy (use of anticoagulant drugs, bleeding disorder, epilepsy, pregnancy or pacemaker), previous experience with shockwave therapy, cortisone injection in affected shoulder within last 6 weeks, SPADI score below 20.

Device: Enimed Swiss DolorClast. A 'power' handpiece was used, which generates more energy than a regular handpiece. Treatment consisted of 2,000 impulses on each painful shoulder tendon with a pressure between 1.5 and 3.0 bar (0.01 to 0.35 mJ/mm²), depending on what the patient could tolerate. Treatment sessions were offered once a week for 4 weeks.

The sham probe was similar to the active one in design, shape and sound, but no shockwaves were conducted.

All patients had supervised exercises with experienced physiotherapists, once per week for the first 4 weeks and then twice per week for the next 8 weeks. Each session lasted 40 minutes.

1 year

The authors reported no conflicts of interest. The study was funded by Sophies Minde Ortopedi. The funder had no role in the design of the study, data collection, analysis or interpretation, or writing the article.

SPADI

51.8 (17.5)

26.9 (27.3)

51.9 (16.7)

28.3 (24.2)

-1.6 (-10.2 to 6.96)

0.71

Pain at rest (0 to 10)

4.4 (2.4)

2.2 (2.5)

4.3 (2.2)

2.3 (2.4)

-0.1 (-0.1 to 0.7)

0.73

Pain during activity (0 to 10)

6.4 (2.1)

3.5 (2.8)

6.7 (1.8)

3.6 (2.1)

-0.1 (-1.1 to 0.87)

0.80

Function – 'can you carry a shopping bag (5 kg)?' (0 to 10)

4.9 (3.1)

3.2 (3.2)

5.5 (2.7)

3.3 (3.1)

-0.3 (-0.7 to 1.3)

0.60

Function – 'can you take something down from a shelf?' (0 to 10)

6.6 (2.4)

3.4 (3.3)

6.4 (2.9)

3.7 (3.2)

-0.3 (-1.4 to 0.8)

0.59

Health-related quality of life (EQ-5D) (-0.59 to 1)

0.53 (0.29)

0.71 (0.26)

0.58 (0.24)

0.73 (0.25)

-0.0 (-0.1 to 0.1)

0.94

RCT

Egypt

2016 to 2019

n=45 (15 focused ESWT, 15 radial ESWT, 15 combined ESWT)

Patients with calcific shoulder tendinopathy

Mean 50.9 years (range 30 to 68); 62% (28/45) female

Inclusion criteria: patients with clinically diagnosed calcific shoulder tendinopathy with no improvement after 3 months of treatment with conventional physical therapy such as ultrasound, laser, and exercise, or medical treatment or local corticosteroid injection.

Exclusion criteria: age under 18 years, malignancy, clotting problems, use of anticoagulants, other causes of shoulder pain such as previous trauma or operation of the shoulder, shoulder arthritis, referred pain to the shoulder region from sites extrinsic to the shoulder joint such as the cervical spine, brachial plexus, thoracic outlet, peripheral nerve affection, wound or local infection in the shoulder and hemiplegia.

Device: DUOLITH SD1 Tower (STORZ MEDICAL AG.)

Focused ESWT: 1,500 shocks, with energy level 0.3 mj/mm² and frequency 4 Hz.

Radial ESWT: 2,000 shocks, with energy level 2.5 bars and frequency 10 Hz.

Combined ESWT: 1,500 shocks and 2,000 shocks with the above parameters.

Patients of the 3 groups had 4 sessions, 1 week apart, lasting 10 to 15 minutes. The contact head was positioned at the marked site of calcification which was defined by sonography before each treatment. A cold pack was sometimes applied after the session to relieve pain and discomfort. No medications or exercise were prescribed during treatment.

3 months

None

VAS (0 to 10); median (IQR)

8 (2)

4 (3)

<0.001

7 (2)

3 (3)

<0.001

8 (2)

0 (3)

<0.001

Abduction (0 to 180); mean (SD)

114.0 (27.2)

151.7 (19.6)

<0.001

106.0 (38.3)

151.0 (27.0)

<0.001

87.3 (29.6)

174.0 (6.3)

<0.001

Internal rotation (0 to 90); mean (SD)

39.0 (15.3)

66.0 (11.2)

<0.001

39.7 (19.0)

75.7 (10.2)

<0.001

29.0 (8.7)

78.7 (7.4)

<0.001

Shoulder disability questionnaire (0 to 100); mean (SD)

85.8 (16.2)

34.2 (23.1)

<0.001

84.9 (14.4)

29.2 (18.6)

<0.001

87.5 (14.9)

17.2 (15.8)

<0.001

Calcification size (mm); median (SD)

8.7 (8.3)

3 (4)

<0.001

9 (7.2)

4.7 (5)

<0.001

11 (8.2)

0 (5.3)

<0.001

VAS

4.40 (2.35)

4.47 (1.72)

6.58 (1.92)

0.014

Abduction

37.7 (22.6)

45.0 (34.1)

86.7 (31.3)

<0.001

Internal rotation

27.0 (13.2)

36.0 (16.3)

49.7 (13.6)

<0.001

Shoulder disability questionnaire

51.7 (19.9)

55.7 (20.6)

70.4 (16.8)

0.034

Calcification size (mm)

5.72 (3.64)

5.58 (2.79)

8.83 (3.49)

0.025

Non-randomised comparative study (comparing patients with different types of tendinosis)

Taiwan

1998 to 2015

n=60 (20 non-calcified tendinosis, 20 translucent calcified tendinosis type 2 and 3, 20 dense calcified tendinosis type 1)

Patients with symptomatic calcific and non-calcific rotator cuff tendinosis

Non-calcified tendinosis: mean age 52.4 years (range 42 to 68); 65% (13/20) female

Translucent calcified tendinosis: mean age 53.3 years (range 32 to 78); 65% (13/20) female

Dense calcified tendinosis: mean age 53.0 years (range 32 to 78); 70% (14/20) female

Patients with clinical symptoms, such as pain or disability, which lasted for more than 6 months, confirmed by ultrasonography or MRI. Patients with symptoms that did not respond to conservative treatment, such as physiotherapy, non-steroidal anti-inflammatories, or analgesics, for 3 months were referred for ESWT if they had no contraindications, which included pregnancy, coagulopathy, acute infection, or malignancy. Patients who had a full-thickness tear or type 2 or 3 acromion were also excluded.

The electrohydraulic shockwave was produced using Ossatron (Sanuwave, Georgia) or Orthospec equipment (Medispec Ltd., Israel). 3,000 impulses were delivered at 16 kv to 18 kv (0.32mJ/mm² energy flux density) with the Ossatron or at level 7 (0.32mJ/mm²) for the Orthospec under image guide on the tendon with calcific deposition and on the point of maximal tenderness in patients without calcification. The procedures were done without anaesthesia or analgesics.

All current treatments were discontinued 2 weeks before ESWT until 4 weeks after ESWT.

12 months

None

VAS - before

5.5 (0.76); 4 to 7

5.4 (1.04); 2 to 8

5.4 (0.94); 3 to 7

0.944

VAS - after

2.9 (2.86); 0 to 9

1.5 (2.48); 0 to 6

3.8 (2.46); 0 to 6

0.011

p value

0.001

<0.001

0.02

CMS pain score - before

4.6 (0.88); 2 to 6

4.1 (1.00); 2 to 6

4.6 (0.6); 3 to 5

0.091

CMS pain score - after

7.7 (2.13); 3 to 10

8.8 (2.00); 4 to 10

6.5 (2.16); 4 to 10

0.004

p value

0.001

<0.001

0.003

CMS night pain - before

2.6 (0.83); 1 to 4

2.6 (0.94); 1 to 4

2.6 (0.5); 2 to 3

0.985

CMS night pain - after

4.2 (1.04); 2 to 5

4.3 (1.13); 2 to 5

3.3 (1.20); 2 to 5

0.012

p value

<0.001

<0.001

0.03

Strength - before

12.6 (3.66); 5 to 20

11.2 (3.23); 5 to 16

12.7 (3.08); 7 to 18

0.349

Strength - after

19.2 (5.22); 8 to 25

22.4 (5.10); 8 to 25

18.4 (4.69); 10 to 25

0.002

p value

<0.001

<0.001

0.001

Activity - before

10.8 (3.16); 5 to 5

10.0 (2.51); 6 to 16

10.7 (2.56); 6 to 16

0.626

Activity - after

16.1 (4.16); 10 to 23

17.6 (4.24); 6 to 20

14.7 (4.13); 8 to 20

0.031

p value

0.001

<0.001

0.002

Motion - before

22.0 (8.41); 8 to 34

21.9 (7.99); 6 to 36

23.3 (5.20); 16 to 36

0.721

Motion - after

31.7 (7.18); 14 to 38

33.9 (7.77); 16 to 40

28.3 (7.06); 18 to 40

0.030

p value

0.002

<0.001

0.005

Overall CMS - before

52.5 (14.5); 21 to 74

49.7 (9.03); 33 to 62

53.8 (7.66); 42 to 64

0.409

Overall CMS - after

78.7 (18.3); 38 to 98

86.9 (19.7); 40 to 100

71.1 (17.8); 44 to 98

0.007

p value

0.001

<0.001

0.001

Complaint-free

3 (15)

14 (70)

5 (25)

Significantly better

7 (35)

1 (5)

6 (30)

Slightly better

5 (25)

1 (5)

2 (10)

Unchanged

5 (25)

4 (20)

7 (35)

RCT

The Netherlands

2014 to 2017

n=82 (41 high-energy ESWT, 41 ultrasound-guided needling)

Patients with symptomatic calcific tendonitis of the rotator cuff

ESWT: mean age 51.6 years; 66% (27/41) female

Ultrasound-guided needling: mean age 52.7 years; 63% (26/41) female

Inclusion criteria: age >18 years, clinical sign of subacromial pain syndrome, standardised radiographs showing a calcific deposit with a diameter of at least 5 mm in size, morphologic type 1 and type 2 deposits according to Gartner (type 1, sharply outlined and densely structured; type 2, sharply outlined and inhomogeneous or homogenous with no defined border), symptoms for more than 4 months, a completed and unsuccessful nonsurgical treatment program including nonsteroidal anti-inflammatory drugs, physiotherapy and at least 1 subacromial corticosteroid injection.

Exclusion criteria: ultrasonic signs of a partial or full rotator cuff tendon tear, clinical or radiographic signs of a resorption phase, defined as increased pain in combination with a morphologic type 3 deposit (cloudy and transparent in structure) on radiographs, calcific deposits in multiple tendons of the rotator cuff, osteoarthritis of the glenohumeral or acromioclavicular joint, adhesive capsulitis, previous shoulder surgery, ESWT or ultrasound-guided needling to the affected shoulder, instability of the shoulder, rheumatoid arthritis, neurologic disorders or dysfunction of the upper limb and the inability to give informed consent.

ESWT device: Piezowave2 system (Richard Wolf GmbH, Germany). Patients had 4 sessions of high-energy ESWT with a 1-week interval. Each session consisted of 2,000 piezoelectric pressure pulses, focused on the calcific deposit, at a frequency of 4 Hz with a total energy flux density of 0.351 mJ/mm² resulting in a total energy amount of 2,808 mJ. The calcific deposit was localised by ultrasound with the patient positioned in a supine position. The shoulder was cooled with ice packs after treatment if necessary.

Ultrasound-guided needling: a double-needle technique was used with repeated perforation of the deposit and subsequent aspiration and lavage. Patients had a single procedure, which was combined with a corticosteroid ultrasound-guided subacromial bursa injection.

After treatment, both groups followed a standardised physical therapy program including active and passive exercise mobilisation techniques.

1 year

1 author reported grants from Spaarne General Hospital and nonfinancial support from Richard Wolf GmbH, during the conduct of the study, 1 author reported personal fees from Zimmer Biomet, grants from Zimmer Biomet, and grants from Stryker, outside the conduct of the study, 1 author reported grants from Wright Medical Group and grants from Smith & Nephew, outside the submitted work and 1 reported personal fees from DePuy Synthes and Link Lima, outside the submitted work.

CMS – 6 weeks

7.6 (3.5 to 11.7)

5.1 (0.8 to 9.4)

0.40

CMS – 3 months

9.9 (5.4 to 14.4)

7.0 (2.4 to 11.7)

0.37

CMS – 6 months

13.3 (7.8 to 18.8)

12.4 (7.1 to 17.6)

0.80

CMS – 1 year

15.7 (10.1 to 21.3)

20.9 (16.9 to 24.8)

0.13

DASH – 6 weeks

-12.3 (-17.2 to -7.4)

-5.0 (-9.9 to -0.2)

0.04

DASH – 3 months

-13.2 (-19.3 to -7.1)

-6.4 (-12.4 to -0.4)

0.11

DASH – 6 months

-17.6 (-24.1 to -11.1)

-13.6 (-18.5 to -8.7)

0.32

DASH – 1 year

-20.7 (-27.2 to -14.2)

-20.1 (-25.4 to -14.8)

0.87

VAS pain – 6 weeks

-1.6 (-2.3 to -0.9)

-0.9 (-1.7 to 0.03)

0.19

VAS pain – 3 months

-1.7 (-2.6 to -0.7)

-1.1 (-2.1 to -0.1)

0.41

VAS pain – 6 months

-2.3 (-3.3 to -1.3)

-2.9 (-3.6 to -2.2)

0.28

VAS pain – 1 year

-2.6 (-3.7 to -1.6)

-3.9 (-4.6 to -3.1)

0.05

(strong) decline

3 (8)

1 (3)

neutral

10 (26)

8 (20)

(strong) improvement

26 (67)

31 (78)

No change

17 (42)

0 (0)

Less than 50%

6 (15)

1 (3)

More than 50%

4 (10)

12 (30)

Full resorption

14 (34)

27 (68)

Non-randomised comparative study (1 versus 2 sessions of high-energy ESWT)

Germany

1995 to 1996

n=115 (56 had 1 session of ESWT and 59 had 2 sessions)

Patients with symptomatic chronic calcific tendonitis of the shoulder

Mean 49 years (range 28 to 77); 42% (48/115) female

Inclusion criteria: painful calcific tendonitis for more than 12 months and conservative treatment (physiotherapy and subacromial steroid injections) for at least 6 months without effect. The calcific deposit had to have a homogeneous structure or a sharp outline (Gartner type 1 or 2) and to be a minimum of 15 mm in diameter.

Exclusion criteria: acute subacromial impingement, ultrasound or MRI documentation of a rotator cuff tear, degenerative arthritis of the shoulder seen on radiography, generalised polyarthritis, neurologic disorders, pregnancy, infections, and tumours.

Device: electromagnetic lithotripter (Compact; Dornier Med Tech, Germany). Local anaesthesia by subcutaneous injection was used. Patients were divided into 2 groups: 1 group had 1 session of 2,000-impulse high-dose shockwave therapy, and the other group had 2 sessions of the identical therapy 1 week apart. From low shockwave energy at the start, the intensity was increased within the first 300 impulses up to an energy flux density of 0.3 mJ/mm².

After ESWT, patients were asked not to have any specific subsequent treatment for at least 6 months but were encouraged to use the arm in daily activities.

4 years

3 months

30

52

Not reported

6 months

47

77

0.046

4 years

93

93

Not reported

P value

<0.05

<0.05

3 months

32

50

Not significant

6 months

45

53

Not significant

4 years

78

87

Not significant

p value

<0.001

<0.001

3 months

62 (16)

62 (17)

Not significant

6 months

67 (17)

69 (19)

Not significant

4 years

88 (8)

85 (8)

Not significant

p value

<0.001

<0.05

Cohort study

Taiwan

1998 to 2014

n=268

Patients with symptomatic calcific tendonitis of the shoulder

Mean 52.5 years; 72% (167/232) female

Patients with a painful shoulder caused by calcific tendonitis that failed to respond to oral medication and physiotherapy within 3 months were included. Calcific deposits were identified radiologically as homogeneous hyperdense areas of varying shape. The diagnosis was initially made on plain radiographs, ultrasound or MRI to confirm the diagnosis and to exclude the possibility of a rotator cuff tear or other conditions including malignancy.

Contraindications for ESWT included pregnancy, acute infection, malignant tumour and coagulopathy, fracture or calcific tendonitis coexisting with a rotator cuff tear.

Electrohydraulic shockwave devices used were either Ossatron (Sanuwave, Georgia) or Orthospec equipment (Medispec Ltd., Israel). Each affected shoulder received 3,000 impulses of the shockwave at 16 kv to 18 kv (0.32 mJ/mm² energy flux density) for Ossatron or Level seven (0.32 mJ/mm²) for Orthospec under ultrasound control in line with the point of maximal tenderness. The total ESWT dosage at each session was 960 (mJ/mm²). Patients who needed a second treatment had the procedure again, 3 months after the first procedure.

All patients were asked to stop their current treatment for 2 weeks before ESWT.

1 year

One author is a member of the advisory committee of Sanuwave (Georgia); this study was done independent of the appointment.

Mean calcification size (mm) (SD)

13.0 (6.7)

23.9 (8.9)

<0.001

Gartner and Heyer classification, % (n) – type 1

6.7 (9/134)

64.5 (69/107)

<0.001

Gartner and Heyer classification, % (n) – type 2

61.9 (83/134)

21.5 (23/107)

-

Gartner and Heyer classification, % (n) – type 3

31.4 (42/134)

14.0 (15/107)

-

Location: acromion (muscle part)

2.2 (3/134)

5.6 (6/107)

<0.001

Location: supraspinatus/infraspinatus (tendon part)

97.8 (131/134)

94.4 (101/107)

-

Intensity of pain – before (SD; range)

5.5 (1.1; 2 to 8)

5.5 (0.9; 3 to 8)

0.983

Intensity of pain – after (SD; range)

1.0 (2.0; 0 to 6)

3.8 (2.4; 0 to 7)

<0.001

p value

<0.001

<0.001

Pain score – before (SD; range)

4.2 (0.8; 1 to 6)

4.3 (0.8; 2 to 6)

0.109

Pain score – after (SD; range)

8.8 (2.1; 3 to 10)

6.1 (2.4; 3 to 10)

<0.001

p value

<0.001

< 0.001

Power – before (SD; range)

13.7 (3.5; 5 to 21)

13.1 (3.0; 5 to 20)

0.150

Power – after (SD; range)

22.7 (4.0; 10 to 25)

17.5 (5.1; 8 to 25)

<0.001

p value

<0.001

<0.001

Activity – before (SD; range)

12.6 (2.8; 5 to 19)

12.1 (2.8; 6 to 18)

0.122

Activity – after (SD; range)

18.8 (2.5; 8 to 20)

14.9 (4.0; 6 to 20)

<0.001

p value

<0.001

<0.001

Movement – before (SD; range)

20.4 (6.4; 6 to 36)

20.5 (6.0; 8 to 38)

0.895

Movement – after (SD; range)

35.0 (7.3; 6 to 40)

26.3 (8.5; 10 to 40)

<0.001

p value

<0.001

<0.001

Constant score – before (SD; range)

53.7 (10.2; 24 to 37)

52.8 (8.0; 37 to 67)

0.435

Constant score – after (SD; range)

90.0 (16.4; 33 to 100)

68.1 (19.8; 37 to 100)

<0.001

p value

<0.001

<0.001

Complaint-free, % (n)

81.4 (109/134)

23.4 (25/107)

<0.001

Significantly better, % (n)

3.7 (5/134)

19.6 (21/107)

<0.001

Slightly better, % (n)

3.0 (4/134)

11.2 (12/107)

0.011

Unchanged, % (n)

11.9 (16/134)

45.8 (49/107)

<0.001

Duration of symptoms (months)

Per 1-month increase

1.06 (1.02 to 1.10)

0.006

Classification

Type 1 versus others

24.8 (9.42 to 65.4)

<0.001

Calcification size (mm)

Per 1 mm increase

1.19 (1.12 to 1.27)

<0.001

Case report

Taiwan

Not reported

n=1

Patient with humeral head osteonecrosis after ESWT for rotator cuff tendinopathy

49 year old female

Not applicable

The patient had 1 session of ESWT each week for 3 consecutive weeks with a piezoelectric system (Piezoson 100; Richard Wolf, Germany). The impulse rate was 3,000 shocks per session with an energy of 0.78 mJ/mm². The total energy was 2,340 mJ/mm².

3 months

None

Case report

Switzerland

1996

n=1

Patient with humeral head osteonecrosis after ESWT for shoulder calcific tendonitis

59 year old female

Not applicable

The patient had 3 sessions of ESWT over the period of 1 month. At each session, 1,600 to 1,700 impulses were given at a level of 12 to 13 kV.

3 years and 4 months

None