Frassanito 2018.

Study characteristics
Methods	Study design: parallel‐group, 1:1 allocation ratio, single‐centre, randomised, superiority trial Setting: rehabilitation Institute outpatients. The study was carried out at the Scientific Institute of Montescano, Istituti Clinici Scientifici Maugeri, Italy. Timing: from July 2013 to January 2016 Interventions: in the experimental group, patients underwent three sessions (once a week for 3 weeks) of ESWT with kinesio taping applied at the end of each session. Controls underwent three sessions of ESWT only. Sample size: forty‐two patients with rotator cuff calcific tendinopathy. Sample size computation was based on the outcome measure DASH. The estimated sample size was 15 patients per group. Analysis: per‐protocol analysis was conducted.
Participants	Criteria for defining the condition being treated: signs of rotator cuff calcific tendinopathy on imaging (musculoskeletal ultrasound, standard radiography, magnetic resonance) and positivity to specific tests of functionality (Jobe, Lift‐off, Patte, Palm up, Yocum, Neer) Restriction on duration of symptoms: pain and shoulder range of motion limitation in activities of daily living (ADL) for at least 2 weeks Inclusion criteria: age > 18 years, the absence of cognitive impairment and impaired consciousness which could prevent the subject from expressing free and informed consent Exclusion criteria: treatment with intra‐articular infiltration therapy (corticosteroids or corticosteroids/anaesthetic) and/or physical therapy to the affected shoulder within 4 weeks prior to the study, ongoing cortisone or non‐steroidal anti‐inflammatory (NSAID) therapy, partial or complete tear of the tendons of the rotator cuff on imaging, severe glenohumeral and/or acromioclavicular osteoarthritis, surgery for direct shoulder injury, concomitant cervical symptoms consistent with radiculopathy, outcomes of neurological diseases involving the shoulder, dermatological diseases, damaged skin (scars, infections, or ulcerations not fully healed) involving the affected shoulder, blood coagulation diseases or anticoagulant therapy, decompensated diabetes, tumours, bone infections, pregnancy, presence of a pacemaker, rheumatoid arthritis or other connective tissue diseases, and allergy to adhesive tape Baseline characteristics: Intervention: extracorporeal Shock Wave Therapy (ESWT) + Kinesio Taping (KT) Number randomised: 24 Number included in analyses: 21 (3 lost to follow‐up) Age: 54.1 ± 10.3 years Sex: M 7 (33%); F 14 (66%) Diagnosis: calcific tendinopathy of the rotator cuff Dominant shoulder affected: 13 (62%) Mean (SD) pain (VAS 0‐10): 6.6 (1.5) Mean (SD) function (DASH): 33.6 (12.1) Comparator: ESWT Number randomised: 26 Number included in analyses: 21 (5 lost to follow‐up) Age: 48.7 ± 11.9 years Sex: M 9 (43%); F 12 (57%) Diagnosis: calcific tendinopathy of the rotator cuff Dominant shoulder affected: 11 (52%) Mean (SD) pain (VAS 0‐10): 6.7 (1.1) Mean (SD) function (DASH): 31.1 (8.9) Pretreatment group differences: no between‐group differences were observed.
Interventions	Experimental: KT Tape: Kinesio tape 2 in (5 cm); taping method: Kase protocol; target: deltoid, supraspinatus; number of applications: 3; single application duration: 3 dd; provider: not reported; Co‐intervention: extracorporeal shock wave therapy Control: ESWT Delivered at 4 Hz, with 1800 pulses, and energy flux density ranging from 0.07 to 0.15 mJ/mm2; patient in sitting position and the affected arm extended alongside the body and rotated max 15° internally and externally
Outcomes	Pain Intensity: assessed by Visual Analog Scale (VAS). All patients were evaluated before treatment (T0) and at 1 (T1), 4 (T2) and 12 weeks (T3) after the end of treatment. Disability of the arm: disabilities of the arm, shoulder and hand questionnaire (DASH). All patients were evaluated before treatment (T0) and at 1 (T1), 4 (T2) and 12 weeks (T3) after the end of treatment. Higher scores of DASH indicates worse‐off disabilities. Shoulder function: Subjective Shoulder Rating Questionnaire (SSRQ). All patients were evaluated before treatment (T0) and at 1 (T1), 4 (T2) and 12 weeks (T3) after the end of treatment. Oxford Shoulder Score (OSS). All patients were evaluated before treatment (T0) and at 1 (T1), 4 (T2) and 12 weeks (T3) after the end of treatment. Adverse events Outcomes used in this review The following outcomes were considered at the end of treatments: Pain (VAS 0‐10) Function (DASH) Adverse events
Notes	No source of findings declared. The authors certified that there was no conflict of interest with any financial organisation regarding the material discussed in the manuscript. Trial registration: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"a computer‐generated list of random numbers obtained with the Matlab random numbers generator"
Allocation concealment (selection bias)	Low risk	"The sequence was concealed until assignment and the personnel enrolling participants did not know in advance which treatment the patient was assigned".
Blinding of participants (performance bias)	High risk	Nature of delivered intervention
Blinding of personnel (performance bias)	High risk	Nature of delivered intervention
Blinding of outcome assessment (detection bias) self‐reported outcomes	High risk	No information for judgement. However, blinding of participants not possible because of nature of delivered intervention
Blinding of outcome assessment (detection bias) assessor‐reported outcomes	Low risk	No objective outcome planned and assessed
Incomplete outcome data (attrition bias) All outcomes	Low risk	No high percentage and unbalanced loss to follow‐up. No intention‐to‐treat analysis
Selective reporting (reporting bias)	Unclear risk	No published protocol
Unequal use of co‐intervention	Low risk	KT with other conservative treatment versus the same conservative treatment