5 Safety

5 Safety

This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Transient skin reddening occurred in all patients treated by extracorporeal shockwave therapy (ESWT) in 1 RCT (Rompe 2007) and in 3 patients each in the 2 case-control studies (Furia 2006 and 2008) included in a systematic review of 11 studies. Some patients reported the presence of cutaneous bruises after the applications of ESWT in the case series of 102 patients with Achilles tendinopathy (number not reported).

5.2 Pain during ESWT in 2 patients and transient numbness for 24 hours after ESWT in 1 patient was reported in a case-control study (Furia 2006) included in the systematic review of 11 studies.

5.3 Calf ache was reported in some patients who had eccentric loading exercise in 1 RCT (Rompe 2007, numbers not reported), and in an equal number ('the majority') of patients in both groups in another RCT (Costa 2005, numbers not reported) included in the systematic review of 11 studies.

5.4 Achilles tendon rupture 2 weeks after the first ESWT treatment session, associated with falls, was reported in 2 patients in 1 RCT (Costa 2005) included in the systematic review of 11 studies.

5.5 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers considered that the following were theoretical adverse events: persistent or worsening symptoms and damage to the soft tissues.

5.6 Twelve commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)