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. 2020 Mar 4;2020(3):CD008962. doi: 10.1002/14651858.CD008962.pub2

Haake 2002.

Methods Study design: parallel‐group, two‐arm, single‐blind, RCT
Setting: Germany
Trial time period: participant enrolment from September 1998 to December 1999
Interventions: ESWT focused on the origin of supraspinatus tendon vs ESWT focused on the calcific deposit
Sample size calculation: sample size calculation not performed
Analysis: ITT
Participants Number of participants:
  • screened: not reported

  • enrolled: 50

  • randomised: 50 (25 in ESWT to calcific deposit group and 24 in ESWT to supraspinatus tendon (tuberculum majus) group); 1 participant in ESWT to supraspinatus tendon group never returned after the initial visit

  • included in analyses at 12 weeks: 47 (24 in ESWT to calcific deposit group and 23 in ESWT to supraspinatus tendon group)

  • included in analyses at 12 months: 49 (25 in ESWT to calcific deposit group and 24 in ESWT to supraspinatus tendon group)


Inclusion criteria
  • symptomatic calcifying shoulder tendinopathy

  • symptoms for ≥ 6 months

  • Gärtner Stage I or II deposit

  • ≥ 0.5 cm diameter

  • free ROM or ≥ 90 degrees abduction and free rotation

  • failed conservative treatment including a minimum of: 10 sessions of physiotherapy plus 2 subacromial injections plus 6 sessions of physical therapy plus intake of NSAIDs

  • no treatment in past 4 weeks


Exclusion criteria
  • glenohumeral or acromioclavicular joint arthrosis

  • previous operations to the treated shoulder

  • acute bursitis of the shoulder

  • instability of the shoulder

  • local tumours or infections

  • neurological disorders

  • rotator cuff lesion

  • allergy to mepivacaine

  • aged < 18 years

  • pregnancy


Baseline characteristics:
ESWT to supraspinatus tendon (25 participants):
  • mean (SD) pain during rest NRS 0–11 scale: 7.17 (2.53)

  • mean (SD) pain during activity, NRS 0–11 scale: 8.54 (1.91)

  • mean (SD) function Constant 0–100 score: 47.17 (11.53)

  • calcification size: not reported


ESWT to calcific deposit (25 participants):
  • mean (SD) pain during rest, NRS 0–11 scale: 7.08 (2.74)

  • mean (SD) pain during activity, NRS 0–11 scale: 8.56 (1.58)

  • mean (SD) function Constant 0–100 score: 49.96 (10.87)

  • calcification size: not reported


Pretreatment group differences: none
Interventions ESWT to supraspinatus tendon
  • description of modality: adapted shock wave generator Storz Minilith SL‐1 (Storz Medical AG, CH 8280 Kreuzlingen, Switzerland

  • method of administration: subacromial local anaesthesia was given using 15 mL mepivacaine 1%.

  • dose: 2000 impulses of a positive EFD of 0.35 mJ/mm² measured with a membrane hydrophone at 120 impulses per minute were applied using fluoroscopic localisation at the origin of the supraspinatus tendon

  • frequency: 2 sessions at 1 week apart


ESWT to calcific deposit
  • description of modality: as above

  • method of administration: as described above with 1 difference, shock waves were aimed specifically at the calcific deposit

  • dose: as above

  • frequency: as above

Outcomes Measured at 12 weeks and 1 year
Outcomes included in review:
  • function measured by CMS 0–100 with a higher score indicate better function

  • pain at rest measured on visual NRS 0–11, 11 indicating maximum pain

  • complete resorption of calcific deposit

  • participant satisfaction with treatment

  • adverse events

  • withdrawals: due to adverse events, intolerance to treatment or other reasons


Outcomes excluded from review:
  • pain during activity measured on VAS 0–11, 11 indicating maximum pain

  • treatment success rate: success defined as 80% of the normal value in age‐corrected CMS

Source of funding Not reported
Notes Trial registration: not reported
Time points included in review: 12 weeks and 12 months
Data analysis: function and pain at rest extracted at 12 weeks and 1 year; resorption of calcific deposit extracted at 1 year; participant satisfaction extracted at end of study period. Participant satisfaction was extracted as the measure to represent treatment success, over the number achieving 80% of the normal value for the age‐standardised Constant score
Withdrawals: 1/25 in ESWT to supraspinatus tendon group (withdrew consent after randomisation); 0/25 in ESWT to calcific deposit group
Adverse events:
ESWT to supraspinatus tendon:
  • serious adverse events: 0/25

  • other adverse events: 0/25


ESWT to calcific deposit:
  • serious adverse events: 0/25

  • other adverse events: 0/25

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation in permutated blocks.
Allocation concealment (selection bias) Unclear risk Methods not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and outcome assessors blinded to treatment assignments.
Blinding of outcome assessment (detection bias) 
 Self‐reported outcomes Low risk Participants blinded to treatment allocation, thus there was a low risk of detection bias in reporting of self‐reported outcomes (including pain, function and patient satisfaction).
Blinding of outcome assessment (detection bias) 
 Assessor‐reported outcomes Low risk Blinded independent observers assessed other outcomes, such as radiographic assessment.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 1/25 in ESWT to supraspinatus tendon group (withdrew consent after randomisation) and 0/25 in ESWT to calcific deposit group.
Selective reporting (reporting bias) Low risk No published study protocol, but results reported for all outcomes as mentioned in methods, and included major outcomes.
Other bias Low risk No other biases apparent.