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

Kim 2014.

Methods Study design: single‐centre, parallel‐group, two‐arm, RCT
Setting: orthopaedic surgery outpatient department, St Mary's Hospital, the Catholic University of Korea, Seoul, South Korea
Trial time period: November 2005 to March 2011
Interventions: ESWT vs US‐guided needling
Sample size calculation: 30 participants per group were needed to detect a significant difference (mean difference 8 points; SD 12 points) between groups in ASES scores, with power of 80%, at a type I error level of 0.05
Analysis: not ITT
Participants Number of participants:
  • screened for eligibility: 73 (11 excluded; 6 did not meet inclusion, 5 refused to participate)

  • randomised: 62 randomised (32 to ESWT group; 30 to US‐guided glucocorticoid needling group)

  • included in analyses: 54 (29 from ESWT group; 25 from US‐guided glucocorticoid needling group)


Inclusion criteria:
  • diagnosed with unilateral calcium deposition at the supraspinatus tendon, confirmed on radiological examination

  • disease duration > 3 months


Exclusion criteria:
  • other shoulder disease, such as rotator cuff tear, adhesive capsulitis, arthritis, fracture, infection

  • history of treatment for the affected shoulder


Baseline characteristics:
ESWT (32 participants): 
  • mean (range) age: 57.4 (47–78) years

  • number male/female: 3/26

  • mean (range) calcium deposit size: 11 (4.9–19.3) mm

  • mean pain, VAS 0–10: 6.3

  • mean function ASES 0–100 score: 49.9


US‐guided glucocorticoid needling (30 participants): 
  • mean (range) age: 53.9 (45–76) years

  • number male/female: 2/23

  • mean (range) calcium deposit size: 14.8 (6.6–31) mm

  • mean pain, VAS 0–10: 6.8

  • mean function ASES 0–100 score: 41.5


Pretreatment group differences: none
Interventions ESWT:
  • description of modality used: ESWT

  • method of administration: all participants underwent US examination to evaluate the characteristics of calcium deposits at the affected shoulder in sitting position. All procedures were performed in sitting position by 1 technician. Treatment was aimed at the maximum sore spot according to anatomic targeting

  • dose: 1000 impulses, 0.36 mJ/mm²

  • frequency: 3 sessions, 1 week apart

  • co‐interventions: oral NSAIDs were prescribed at the end of the procedure for 7 days. Participants were permitted to perform daily normal activities to the extent possible, without any immobiliser brace


US‐guided needling:
  • description of modality used: US‐guided needling

  • method of administration: all US‐guided needling procedures were performed by 1 orthopaedic surgeon with a single needle without lavage. The procedure was performed by sterile technique and surgical gloves. A diagnostic US examination was performed to evaluate the characteristics of calcium deposits at the affected shoulder in sitting position. The skin was then cleaned with a 10% iodopovidone solution 3 times and antiseptically draped. After administration of local anaesthesia (2% lidocaine), the participants in this group underwent multiple percutaneous punctures for each deposit with an 18‐gauge needle under real‐time monitoring with US. The final step in procedure was an injection of 1 mL methylprednisolone acetate 40 mg into the subacromial space under US guidance

  • dose: 1 mL methylprednisolone acetate 40 mg (Depo‐Medrol; Pharmacia & Upjohn, Kalamazoo, MI, USA; 40 mg/mL)

  • frequency of administration: once

  • co‐interventions: as above

Outcomes Measured at 6 weeks, 12 weeks, 6 months, 12 months, and last follow‐up visit. Mean follow‐up: 23.0 (range 12.1–28.5) months after treatment
Outcomes included in review:
  • calcification size: complete or partial resolution

  • calcification size: size in mm on sonography using the Picture Archiving and Communications System by use of a mouse cursor with automated distance calculation

  • ASES score: 0–100 with a higher score indicating better function

  • pain VAS 0–10, higher score indicating worse pain


Other outcomes in trial, excluded from review
  • function: SST, higher score indicating better function

Source of funding The authors, their immediate families, and any research foundation with which they were affiliated received no financial payments or other benefits from any commercial entity related to the subject of the article
Notes Trial registration: not reported
Time points included in review: 3, 6 and 12 months
Data analysis: no SDs or any other measures of variance were reported or could be calculated for the pain scores or the function scores at follow‐up, thus we could not analyse these outcomes. The size of calcific deposits was extracted at last follow‐up (12 months)
Withdrawals: 3/32 in ESWT group, 5/30 in needling group were lost to follow‐up
Adverse events: not measured
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization was conducted by an independent statistician who provided us with a computer‐generated randomization list."
Comment: adequate.
Allocation concealment (selection bias) Unclear risk Not reported if the randomisation list was concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Neither participants nor personnel were blinded to treatment allocation.
Blinding of outcome assessment (detection bias) 
 Self‐reported outcomes High risk Participants were not blinded to treatment allocation, thus there was risk of detection bias in reporting of pain and function.
Blinding of outcome assessment (detection bias) 
 Assessor‐reported outcomes Unclear risk It was not reported if the radiographer assessing calcification size was blinded and the effect on measurement of this outcome was unclear.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 3/32 (9%) in ESWT group and 5/30 (16.6%) in needling group were lost to follow‐up.
Selective reporting (reporting bias) High risk There was no published study protocol, and measures of variance were not reported at follow‐up for most data.
Other bias Low risk No other biases apparent.