Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 5 randomised controlled trials (1 of which is also included in the systematic review), 2 non-randomised comparative studies, 1 cohort study and 2 case reports. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: patient-reported outcome measures, including pain, function, and quality of life; need for continuing analgesia; and need for further treatment, including surgery.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain during and after the procedure, localised redness, bleeding, bruising and tendon rupture.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee was told that calcific tendinopathy in the shoulder can be a very painful and debilitating condition.
3.6 The committee was told that the procedure should be used together with physiotherapy.
3.7 The committee noted:
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There is more than one technique used for the procedure.
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Evidence on efficacy comes from a heterogeneous group of patients, which made it difficult to determine if there was a group who might benefit from the treatment.
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There were 2 published case reports of humeral head osteonecrosis in people who have had this procedure. This is a serious complication, but it is unclear if it was directly related to the procedure.
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The mechanism of action of extracorporeal shockwave therapy for calcific tendinopathy in the shoulder is unclear.
ISBN: 978-1-4731-4791-1