| Methods |
Study design: parallel‐group, two‐arm, RCT
Setting: not reported
Trial time period: 2‐year trial exact time period not reported
Interventions: low‐dose ESWT vs high‐dose ESWT
Sample size calculation: sample size calculation not performed
Analysis: study did not state if it used ITT analysis |
| Participants |
Number of participants:
screened: not reported at enrolment: 126 (26 excluded due to non‐compliance) randomised: 100 (50 per group) included in analyses: 100 (50 per group)
Inclusion criteria:
calcific tendinitis with shoulder pain > 12 months unsuccessful conservative treatment in past 6 months calcifications minimum 5 mm in diameter type I and II Gärtner classification chronic or subacute pain caused by impingement of the deposit against the edge of the coracoacromial arch (De Palma)
Exclusion criteria:
type III calcifications (cloudy and transparent calcifications) frozen shoulder evidence of subacromial impingement of the rotator cuff detected by sonography or MRI rupture of the detected by sonography or MRI dysfunction in the neck or thoracic region local arthritis, generalised polyarthritis neurological abnormalities pregnancy infection tumour no other treatments or drugs were to be used, neither during the 6 weeks preceding the trial, nor within the follow‐up period.
Baseline characteristics:
Low‐dose ESWT (50 participants)
mean (range) age: 49 (29–68) years number male/female: 25/25 mean (range) duration of symptoms: 25 (12–84) months mean (range) function Constant score: 47 (21–90) calcification size: not reported
High‐dose ESWT (50 participants)
mean (range) age: 47 (29–60) years number male/female: 19/31 mean (range) duration of symptoms: 33 (12–120) months mean (range) function Constant score: 53 (22–81) calcification size: not reported
Pretreatment group differences: none |
| Interventions |
Low‐dose ESWT:
description of modality used: ESWT with an experimental device characterised by the integration of an electromagnetic shock wave generator and a mobile fluoroscopy unit (Siemens AG, 91052 Erlangen, Germany). The machine generates shock waves by passing a strong electric current through a flat coil. This action induces a magnetic field in flat coil, which in turn induces another magnetic field in a metal membrane overlying the flat coil. The focal area has a length of 50 mm parallel to the shot 1 wave axis and a radius of 3.5 mm perpendicular to the shock wave axis. method of administration: once the calcium deposit was located in the centre of the C‐arm, the shock wave unit was docked to the shoulder by means of a water‐filled cylinder. Regular US gel (University Hospital, Mainz, Germany) was used as a contact medium between cylinder and skin. Mean duration of each session 38 minutes (range 24–52 minutes). No anaesthesia was used. dose: 1500 impulses of 0.06 mJ/mm² frequency: 1 session per participant co‐interventions: physiotherapy for 3 days post‐treatment and then home exercises
High‐dose ESWT:
description of modality used: as above method of administration: as above but regional anaesthesia was used dose: 1500 impulses of 0.28 mJ/mm² frequency: as above co‐interventions: as above
|
| Outcomes |
Measured at 6 weeks and 6 months
Outcomes included in review:
function measured by Constant score 0–100, higher score indicating better function calcification size: number of participants with deposits which showed complete or partial resorption on anteroposterior and axial X‐rays of the shoulder participant satisfaction: proportion of participants who were satisfied with their treatment adverse events withdrawals due to adverse events, intolerance to treatment or other reasons
Outcomes excluded from review:
additional treatment after ESWT ROM: Constant score subscore proportion of participants who rated their treatment results as excellent, good, fair or poor
|
| Source of funding |
Not reported |
| Notes |
Trial registration: not registered
Time points included in review: 6 weeks and 6 months
Data analysis: function extracted at 6 weeks and 24 weeks. Complete and partial resorption of calcification and participant satisfaction extracted at 24 weeks. Pain was not able to be extracted as not reported in results section (this is subset of Constant score) as only ranges were reported by the study. The SD for the Constant score was extracted using the WebPlotDigitier program found at arohatgi.info/WebPlotDigitizer/app. As it was unclear whether the graph displayed SEs or SDs, it was agreed that the data would be treated as SDs. The data were extracted and rounded to the nearest whole number. Where measured numbers differed from a reported figure, the reported figure was used
Withdrawals: none
Adverse events:
Low‐dose ESWT:
High‐dose ESWT:
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "The patients were randomly assigned in a blinded fashion to two groups."
Method of randomisation not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Methods were not reported, therefore, there was an unknown risk of selection bias due to unknown allocation concealment. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No information on blinding of study personnel or participants |
| Blinding of outcome assessment (detection bias)
Self‐reported outcomes |
Unclear risk |
Methods of participant blinding were not reported, therefore, there was an unclear risk of detection bias regarding the self‐reported outcomes of Constant score and treatment success. |
| Blinding of outcome assessment (detection bias)
Assessor‐reported outcomes |
Unclear risk |
As blinding of assessors was not reported, there was risk of bias in the measurement of radiographic outcomes. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No withdrawals in either group. |
| Selective reporting (reporting bias) |
High risk |
There was no published study protocol, but results were reported for all outcomes as mentioned in methods. The breakdown of the Constant score was not reported (including pain) and SDs were not provided for any outcome measure. |
| Other bias |
Low risk |
No other biases apparent. |
