Extracorporeal shockwave therapy for plantar fasciitis (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Extracorporeal shockwave therapy for refractory plantar fasciitis

Plantar fasciitis is a painful condition affecting the connective tissue that stretches between the heel and the middle of the foot. It is usually caused by overuse, injury or muscular abnormalities. In extracorporeal shockwave therapy, a machine is used to deliver sound waves to the painful area. It is not known exactly how it works, but it is thought that it might stimulate healing of the fascia.

 

The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of extracorporeal shockwave therapy for refractory plantar fasciitisand will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about extracorporeal shockwave therapy for refractory plantar fasciitis.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 26 May 2009

Target date for publication of guidance: July 2009

 

1 Provisional recommendations
1.1 The evidence on extracorporeal shockwave therapy (ESWT) for refractory plantar fasciitis raises no major safety concerns; however, current evidence on its efficacy is inconsistent. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2

Clinicians wishing to undertake ESWT for refractory plantar fasciitis should take the following actions.

  • Inform the clinical governance leads in their Trusts.
  • Ensure that patients understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
  • Audit and review clinical outcomes of all patients having ESWT for refractory plantar fasciitis (see section 3.1).
1.3 NICE encourages further research into ESWT for refractory plantar fasciitis. Future research should take the form of clinical studies with clearly described patient selection and treatment protocols. The studies should include validated outcome measures and be based on a minimum of 1 year follow-up. NICE may review the procedure on publication of further evidence.
2 The procedure
2.1 Indications and current treatments
2.1.1 Plantar fasciitis is characterised by chronic degeneration of the plantar fascia, which causes pain on the underside of the heel. It is usually caused by injury or biomechanical abnormalities and may be associated with microtears, inflammation or fibrosis.
2.1.2 Conservative treatments include rest, application of ice, analgesic medication, non-steroidal anti‑inflammatory drugs (NSAIDs), orthotic devices, physiotherapy, eccentric training/stretching and corticosteroid injection.
2.2 Outline of the procedure
2.2.1 Extracorporeal shockwave therapy is a non-invasive treatment in which a device is used to pass acoustic shockwaves through the skin to the affected area. Ultrasound guidance can be used to assist with positioning of the device.
2.2.2 Extracorporeal shockwave therapy may be applied in one or several sessions. Local anaesthesia may be used because high-energy ESWT can be painful.
2.2.3 The mechanism by which this therapy might have an effect on tendinopathy is unknown.
Sections 2.3 and 2.4 describe efficacy and 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 overview, available at www.nice.org.uk/IP252aoverview.
2.3 Efficacy
2.3.1 A randomised controlled trial (RCT) of 293 patients treated by ESWT or sham ESWT reported that 47% (67/144) and 30% (42/141) of patients, respectively, had ‘successful’ outcomes at 3-month follow-up (defined as at least 50% reduction in pressure-induced pain and pain during walking, at least a 1-point reduction in pain score on a 5-point visual analogue scale [VAS] [higher scores indicate greater pain], and no requirement for pain medication 10–12 weeks after treatment) (p = 0.008).
2.3.2 In an RCT of 172 patients treated by ESWT or sham ESWT, the mean reduction in pain score (assessed by a 5-point VAS) from baseline to 3-month follow-up was 3.4 in the ESWT group (n = 112) compared with 1.8 in the sham ESWT group (n = 56) (p < 0.001).
2.3.3 An RCT of 149 patients treated by ESWT or conservative management reported that 69% of ESWT patients and no patients treated conservatively had an ‘excellent’ result (no heel pain); 14% and 55% of each group, respectively, had a ‘good’ result (50% or greater reduction in baseline pain); 6% and 36% had a ‘fair’ result (25–50% reduction in heel pain) and 11% and 9%, respectively, had a ‘poor’ result (25% or less reduction in heel pain) at a mean follow-up of 64 months.
2.3.4 The Specialist Advisers stated that the key efficacy outcome was relief of symptoms.
2.4 Safety
2.4.1 The RCTs of 272 and 166 patients reported pain during treatment in 5% (7/135) and 1% (1/81) of ESWT patients, and 2% (2/136) and 1% (1/85) of sham patients, respectively. The RCT of 125 patients reported throbbing pain and erythema requiring ice in 10% (6/61) of ESWT patients, compared with pain requiring analgesia or ice for a mean duration of 7 days in 13% (8/64) of patients who had a single corticosteroid injection.
2.4.2 The RCT of 272 patients reported that 12% (16/135) of ESWT patients and 4% (5/136) of sham ESWT patients had skin reddening. In the RCTs of 272 and 172 patients, 2% (3/135) of ESWT patients and 1 ESWT patient, respectively, had local swelling. The RCTs of 172 and 166 patients reported bruising of the treated area in 2 patients and 1 patient respectively.
2.4.3 The Specialist Advisers listed adverse events as bruising, pain, local skin damage and rupture of the plantar fascia. The Specialist Advisers considered theoretical adverse events to include exacerbation of the condition because the treatment induces an injury, and local soft tissue damage.
2.5 Other comments
2.5.1 The Committee found interpretation of the data difficult because of the diversity of treatment protocols and comparators used, and varying reported end points. The results of studies conflicted and there was evidence of a substantial placebo response. Previous guidance on this procedure published in 2005 had found the evidence on efficacy inadequate, and new evidence has not been published to alter that view. The Committee therefore considered that there is a need for further well-designed research.
2.5.2 Plantar fasciitis is a common condition and many patients who have it are refractory to other treatments. If the procedure is efficacious in selected patients, it therefore has the potential for a high impact. This makes provision of robust data particularly important.
3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing audit support (which is for use at local discretion), which will be available when the guidance is published.
3.2 This document is a review of the published NICE interventional procedure guidance IPG139 published in 2005. For related NICE guidance see www.nice.org.uk.

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

April, 2009

This page was last updated: 30 March 2010