Extracorporeal shockwave therapy for refractory tennis elbow (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Extracorporeal shockwave therapy for refractory tennis elbow

Tennis elbow is a condition affecting the tendons of the elbow which connect the muscles of the forearm to the upper arm bone. It may be associated with tiny tears in the fibres of the tendon and is usually caused by overuse or injury. Symptoms include pain in the outer part of the elbow, weakness or stiffness. 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 tendons.

 

The National Institute for Health and Clinical Excellence (NICE) is examining interventional procedure overview of extracorporeal shockwave therapy for refractory tennis elbow and 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 tennis elbow.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE's guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 tennis elbow 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 tennis elbow 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 tennis elbow (see section 3.1)
1.3 NICE encourages further research into ESWT for refractory tennis elbow. 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 Tennis elbow (also known as lateral epicondylitis) is characterised by chronic degeneration at the origin of theextensor carpi radialis brevis muscle on the lateral epicondyle of the humerus bone usually caused by injury or overuse. Symptoms include pain, weakness and stiffness of the outer elbow.
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/IP773overview.
2.3 Efficacy
2.3.1 In a randomised controlled trial (RCT) comparing 272 patients treated by ESWT or sham ESWT, success was reported in 26% (32/124) and 25% (31/122) of patients, respectively, at 3-month follow-up (success defined as a Roles and Maudsley score of 1 or 2 out of 4 and no requirement for additional treatment). An RCT of 93 patients treated by ESWT or steroid injection reported treatment success (at least 50% improvement in Visual Analogue Scale [VAS] score) in 60% (29/48) and 84% (21/25) of patients, respectively, at 3-month follow-up (p < 0.05).
2.3.2 An RCT of 75 patients treated by ESWT or sham ESWT reported that at 3 months, 35% (14/40) and 34% (13/35) of patients, respectively, had at least a 50% improvement in VAS score for pain during the day (p < 0.01 in both treatment groups); and 30% (12/40) and 43% (15/35) of patients, respectively, had at least a 50% improvement in VAS score for pain at night (p-value stated as ‘non-significant’ and p < 0.05, respectively).
2.3.3 An RCT of 78 patients treated by ESWT or sham ESWT reported a significantly greater reduction in pain (assessed by the Thomsen resisted wrist extension test) in the ESWT group compared with the sham group at 12-month follow-up (p = 0.03).
2.3.4 The Specialist Advisers listed key efficacy outcomes as relief of symptoms and functional improvement.
2.4 Safety
2.4.1 Two RCTs of 272 and 114 patients reported pain in 11% (15/134) and 50% (28/56) of ESWT patients, and 4% (6/136) and 22% (13/58) of sham ESWT patients, respectively.
2.4.2 In the RCT of 272 patients, transient skin reddening occurred in 31% (42/134) of ESWT patients and 8% (11/136) of sham ESWT patients, and transient swelling occurred in 7% (9/134) and 6% (8/136) of patients, respectively.
2.4.3 The RCT of 114 patients treated by ESWT or sham ESWT reported a local reaction (not otherwise described) in 11% (6/56) and 9% (5/58) of patients, respectively. In this study 18% (10/56) of patients in the ESWT group experienced nausea compared with none in the sham ESWT group.
2.4.4 In the RCT of 75 patients, 2 patients in the ESWT group had worsened symptoms after two treatment sessions and withdrew from the study.
2.4.5 The Specialist Advisers listed adverse events as bruising, rupture of the common extensor tendon and transient skin reddening. The Specialist Advisers stated that anecdotal adverse events could include local skin 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 Tennis elbow 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

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.