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

Hearnden 2009.

Methods Study design: single‐centre, parallel‐group, two‐arm, single‐blind randomised placebo‐controlled trial
Setting: orthopaedics referrals from general practice, Wrightington Hospital, UK
Trial time period: not reported
Interventions: ESWT vs placebo
Sample size calculation: not performed
Analysis: ITT
Participants Number of participants:
  • screened: 27 (7 did not meet inclusion criteria)

  • randomised: 20 (11 in ESWT group; 9 in placebo group)

  • included in analyses: 20 (11 in ESWT group; 9 in placebo group)


Inclusion criteria:
  • Gärtner type I or II calcific deposit on X‐ray

  • shoulder pain secondary to supraspinatus tendonitis (diagnosed using MRI in 8 participants or US scan in 15 participants)

  • pain for > 12 months

  • failure of conservative therapy


Exclusion criteria:
  • rotator cuff rupture

  • local arthritic changes or generalised polyarthropathies

  • neurogenic syndromes

  • pregnancy

  • infection

  • coagulation disorders


Baseline characteristics: numerical data were not reported
Pretreatment group differences: authors reported that participants in both groups were well matched in demographics, symptoms and calcific deposits (no numerical data reported)
Interventions ESWT:
  • description of modality: not reported

  • method of administration: location of the calcific deposit was marked on the skin using high‐resolution US by the radiographer. The area was the infiltrated with 20 mL 0.5% marcaine. The lithotripter was then placed on the shoulder and using the in‐line US imaging the ESWT was focused on the deposit, applying the appropriate dose.

  • dose: 2000 shocks fixed at 0.28 mJ/mm²

  • frequency: 1 dose

  • co‐interventions: none


Placebo
  • description of modality: not reported

  • method of administration: as above

  • dose: 20 shocks with a negligible EFD of 0.03 mJ/mm²

  • frequency: 1 dose

  • co‐interventions: none

Outcomes Measured at 6 months
Outcomes included in review:
  • mean change in function measured by CMS, 0–100 with a higher score indicating better function

  • calcification size measured by X‐ray and US

  • mean pain associated with treatment measured on VAS 0–10 cm, higher score indicating more pain

  • treatment success: participant‐reported global assessment of satisfaction as a dichotomous outcome

  • adverse events

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


 Outcomes excluded from review:
  • time to return to work

  • participant‐reported success of outcome measured on a categorical scale (worse, no change, some improvement, complete resolution)

Source of funding Not reported
Notes Trial registration: not reported
Time points included in review: 6 months
Data analysis: function was extracted at 6 months, treatment success was extracted at the study's conclusion (6 months). Pain, calcification size and adverse events could not be extracted as the data were only reported for the intervention group. As no SDs were reported for function and there were none available in study, the SD at 6 months for active and sham groups were taken from Gerdesmeyer 2003.
Withdrawals: none
Adverse events:
ESWT:
  • serious adverse events: 0/11

  • other adverse events: 9/11 (9/11 had pain following shock wave after the effect of the anaesthetic wore off. 7/11 had bruising following shock waves which resolved quickly)


Placebo:
  • serious adverse events: 0/9

  • other adverse events: 0/9

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation 'using a centralised list in blocks to get two equal groups'.
Allocation concealment (selection bias) Low risk Treatment allocations were kept in sealed opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Participants blinded to treatment allocation, not reported if outcome assessors were blinded.
Blinding of outcome assessment (detection bias) 
 Self‐reported outcomes Low risk Participants unaware of treatment received, thus the risk of bias was low for self‐reported outcomes (pain, function and treatment success).
Blinding of outcome assessment (detection bias) 
 Assessor‐reported outcomes Unclear risk Not reported if the radiographer measuring calcification was blinded to the group allocations.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals.
Selective reporting (reporting bias) High risk There was no published study protocol. The summary data for both groups were not reported. VAS pain scores and calcification changes in placebo group were not reported.
Other bias Low risk No other biases apparent.