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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Safety summary

    Overall

    In the systematic review of 2,281 patients, 26% (41/156) of those who had shockwave therapy had an adverse event within 12 months compared with 7% (10/139) of patients in the placebo group (RR 3.61, 95% CI 2.00 to 6.52; 5 trials). These included pain, localised redness, bleeding or bruising and increased shoulder pain after treatment. There were no serious adverse events reported (Surace 2020).

    Humeral head osteonecrosis

    Two case reports of humeral head osteonecrosis after ESWT for rotator cuff tendinopathy and shoulder calcific tendonitis were identified; 1 happened 3 months after the procedure and the other after 40 months (Liu 2006, Durst 2002).

    Pain during procedure

    The mean VAS pain scores during the intervention were 6.2 in the ESWT group and 4.5 in the ultrasound-guided needling group (p<0.001) in the RCT of 82 patients (Louwerens 2020).

    Bursitis

    Severe symptoms of subacromial bursitis were reported in 2% (1/41) of patients who had ESWT and 12% (5/41) of patients who had ultrasound-guided needling within 2 months of the intervention in the RCT of 82 patients. These resolved after a subacromial corticosteroid injection (Louwerens 2020).

    Hypertrophic bursitis was reported in 3 out of the 22 patients who had surgery within 4 years of ESWT in the non-randomised comparative study of 115 patients (Daecke 2002).

    Frozen shoulder

    Frozen shoulder was reported in 1 patient who had ESWT and 1 who had ultrasound-guided needling in the RCT of 82 patients (Louwerens 2020).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

    For this procedure, professional experts did not describe any additional anecdotal adverse events. They considered that the following were theoretical adverse events: haematoma and possible risk of injury to tendon.