4 Efficacy

This section describes efficacy 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.

Extracorporeal shockwave therapy (ESWT) for non-insertional (mid-portion) Achilles tendinopathy

4.1 In a systematic review and meta-analysis on ESWT (n=633), evidence for mid-portion Achilles tendinopathy (tendinopathy 2 to 6cm from the insertion into the calcaneus) was reported from 2 randomised controlled trials (RCTs) of 75 and 68 patients respectively (Rompe 2007, Rompe 2009). The RCT of 75 patients (Rompe 2007) compared ESWT (n=25) with eccentric loading exercise (n=25) and found no statistically significant effects on pain and functional outcomes at 4‑month follow-up (Visual analogue scale [VAS] score standard mean difference [SMD] 0.17, 95% confidence interval [CI] −0.38 to 0.73; Victorian institute of sport assessment questionnaire–Achilles [VISA-A] score SMD 0.29, 95% CI −0.27 to 0.85; Likert scale risk ratio 1.20, 95% CI 0.64 to 2.25). The study also compared ESWT (n=25) with a 'wait and see' group (no-treatment control, n=25) and found statistically significant effects that favoured ESWT at 4‑month follow-up (VAS score SMD −0.93, 95% CI −1.52 to −0.34; VISA-A score SMD −1.03, 95% CI −1.62 to −0.44; Likert scale risk ratio 0.63, 95% CI 0.40 to 1.00). The RCT of 68 patients (Rompe 2009) comparing combined ESWT and eccentric loading exercise in mid-portion Achilles tendinopathy (n=34) with eccentric loading exercise alone (n=34) found greater improvement in pain and function at 4‑month follow-up (VAS score SMD −0.53, 95% CI −1.01 to −0.05; VISA-A score SMD −0.76, 95% CI −1.25 to −0.27; Likert scale risk ratio 0.40, 95% CI 0.18 to 0.91).

4.2 The systematic review also reported evidence from a case-control study of 68 patients (Furia 2008) comparing ESWT (n=34) with conservative treatment including rest, footwear modification, anti-inflammatory medication, and gastrocnemius-soleus stretching and strengthening (n=34) and found that ESWT was statistically significantly better in improving pain and functional outcomes at 3–month follow‑up (VAS score SMD −3.75, 95% CI −4.56 to −2.95; Roles and Maudsley score SMD 0.20, 95% CI 0.09 to 0.46) and after follow up of at least 12 months (VAS score SMD −3.42, 95% CI −4.18 to −2.66; Roles and Maudsley score risk ratio 0.20, 95% CI 0.09 to 0.46).

ESWT for insertional Achilles tendinopathy

4.3 In the systematic review and meta-analysis on ESWT (n=633), evidence for insertional Achilles tendinopathy (tendinopathy up to 2 cm from the insertion into the calcaneus) was reported from 1 RCT of 50 patients (Rompe 2008) comparing ESWT (n=25) to eccentric loading exercise (n=25). It found statistically significant improvement for outcomes of pain and function at 4‑month follow-up (VAS score SMD −0.86, 95% CI −1.44 to −0.27; VISA-A score SMD −1.54, 95% CI −2.18 to −0.91; Likert scale risk ratio 0.50, 95% CI 0.28 to 0.89).The systematic review also reported evidence from 1 case-control study of 68 patients (Furia 2006) comparing ESWT (n=34) with conservative treatment including rest, footwear modification, anti-inflammatory medication, and gastrocnemius-soleus stretching and strengthening (n=34) and found that ESWT was statistically significantly better in improving pain and functional outcomes at 3‑month follow‑up (VAS score SMD −2.42, 95% CI −3.05 to −1.78; Roles and Maudsley score SMD 0.28, 95% CI 0.13 to 0.62) and after follow-up of at least 12 months (VAS score SMD −2.39, 95% CI −3.02 to −1.76; Roles and Maudsley score risk ratio 0.28, 95% CI 0.13 to 0.62). The effect of ESWT was diminished when a local anaesthetic was administered before treatment in this study.

ESWT for non-insertional (mid-portion) or insertional Achilles tendinopathy

4.4 In a systematic review and meta-analysis of 246 patients, evidence from meta-analysis of data from 2 RCTs (Rompe 2007, patients with mid-portion tendinopathy; Rompe 2008, patients with insertional tendinopathy) found no significant effects on pain and functional outcomes at 16‑week follow‑up (VISA-A score SMD −0.55, 95% CI −2.21 to 1.11).

4.5 In the systematic review and meta-analysis on ESWT (n=633), evidence for mid-portion or insertional Achilles tendinopathy was reported from 2 RCTs of 49 and 48 patients respectively (Costa 2005, Rasmussen 2008) comparing ESWT with no treatment (placebo). The RCT of 49 patients (Costa 2005) found no significant difference between ESWT (n=22) and sham treatment (n=27) at 3‑month follow-up (VAS score SMD −0.44, 95% CI −1.01 to 0.13; Functional index of lower limb activity [FILA] SMD −1.05, 95% CI −1.65 to −0.45; EQ-5D SMD −0.21, 95% CI −0.77 to 0.36). The RCT of 48 patients (Rasmussen 2008) used the same intervention as Costa 2005 but with a higher energy level and an extra treatment session. It found that patients in the ESWT group had significantly better American orthopaedic foot and ankle society (AOFAS) scores than the sham group at 3‑month follow-up (SMD −0.52, 95% CI −1.09 to 0.06). The 3 prospective studies (Firdman 2008, Saxena 2011, Vulpiani 2009) included in this systematic review reported improvements in pain and functional outcomes at an average follow up of 20 to 24 months.

4.6 The specialist advisers listed key efficacy outcomes as pain reduction, pain relief and improved function.

4.7 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)