Interventional procedure consultation document

Extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome

Treating greater trochanteric pain syndrome using shockwave therapy

The greater trochanter is the bony bump on the outer side of the hip. This area may become painful following hip surgery or as a result of inflammation of the fluid-filled sac (bursa) that allows smooth motion between bones and tendons or muscles. Such inflammation (bursitis) is often caused by minor repetitive trauma or a direct injury.

In extracorporeal shockwave therapy, a machine is used to deliver sound waves to the painful area, with the aim of stimulating healing.

The National Institute for Health and Clinical Excellence (NICE) is examining extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome 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 greater trochanteric pain syndrome.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 28 September

Target date for publication of guidance: January 2010

1 Provisional recommendations

1.1 Evidence on the efficacy and safety of extracorporeal shockwave therapy (ESWT) for refractory greater trochanteric pain syndrome is limited in quality and quantity. 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 greater trochanteric pain syndrome should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure’s safety and efficacy. In particular, patients should be informed about the possibility of pain during and after treatment, and the risk that symptoms may worsen. They should be provided 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/guidance/IPGXXXpublicinfo). [[details to be completed at publication]]
• Audit and review clinical outcomes of all patients having ESWT for refractory greater trochanteric pain syndrome (see section 3.1).

1.3 This procedure should only be carried out by clinicians with specific training in the administration of ESWT for refractory greater trochanteric pain syndrome and in accordance with manufacturer’s instructions.

1.4 NICE encourages further research into ESWT for refractory greater trochanteric pain syndrome. Research studies should clearly describe patient selection, imaging, and treatment protocols. Outcomes should include functional and quality-of-life scores with at least 1-year of follow-up.

2 The procedure

2.1 Indications and current treatments

2.1.1 Greater trochanteric pain syndrome is a disorder that affects the (lateral) side of the hip or hips. Greater trochanteric pain may be associated with overuse and with inflammation of the troachanteric bursa, a small fluid sac that separates the greater trochanter of the femur and the overlying fascia lata to allow smooth movement (also known as trochanteric bursitis). Greater trochanteric pain may also be associated with direct injury, tendon damage, infection, differences in leg length or hip-replacement surgery.

2.1.2 Greater trochanteric pain syndrome is usually managed conservatively with rest, physiotherapy, anti-inflammatory medication and corticosteroid injections. In patients refractory to conservative treatments, surgical options including iliotibial band lengthening, supratrochanteric fasciotomy or trochanteric bursectomy may be used.

2.2 Outline of the procedure

2.2.1 Extracorporeal shockwave therapy (ESWT) 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 ESWT may be applied in one or several sessions. Local anaesthesia may be used because high-energy ESWT can be painful. Different energies and frequency of shockwaves can be used.

2.2.3 The mechanism by which this therapy might have an effect on greater trochanteric pain syndrome 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/IP858overview

2.3 Efficacy

2.3.1 A non-randomised comparative study of 229 patients treated by several ESWT sessions (n = 78), a single local corticosteroid injection (n = 75) or ‘home training’ (n = 76) reported that the percentage of patients who had either recovered completely or had improved symptoms (assessed using a 6-point Likert scale) following ESWT were 13% (10/78) at 1 month, 68% (53/78) at 4 months and 74% (58/78) at 15 months. In the corticosteroid injection group, 75% (56/75) of patients reported complete recovery or improved symptoms at 1 month, 51% (38/75) at 4 months and 48% (36/75) at 15 months. In the home-training group 7% (5/76) of patients reported complete recovery or improved symptoms at 1 month, 41% (31/76) at 4 months and 80% (61/76) at 15 months.

2.3.2 The non-randomised comparative study of 229 patients reported significantly higher mean pain scores (measured on a visual analogue scale from 0–10; 10 indicates worst conceivable pain) in the ESWT (5.6) and the home training groups (5.9) compared with the steroid injection group (2.2) at 1 month (p < 0.001). However, at 15 months the scores were 2.4 after ESWT, 2.7 after home training and 5.3 after injection (p < 0.001). All groups had similar pain scores at baseline (range 5.8–6.3).

2.3.3 The non-randomised comparative study of 229 patients reported that 64% (50/78) of patients in the ESWT group, 49% (37/75) in the steroid injection group and 34% (26/76) in the home training group had returned to previous sporting or recreational activity at 4 months (ESWT vs injection, p < 0.05 and ESWT vs home training, p < 0.001).

2.3.4 The Specialist Advisers listed key efficacy outcomes as recovery measured on 6-point Likert scale, severity of pain measured using a visual analogue scale and improved function.

2.4 Safety

2.4.1 Increased pain for more than 1 day was reported in 2% (2/78) of patients treated by ESWT, 24% (18/75) treated by steroid injection and 20% (15/76) treated with home training in the non-randomised comparative study of 229 patients.

2.4.2 Skin irritation during the first month of follow-up was reported in 33% (26/78) of patients treated by ESWT and 3% (2/75) treated by injection in the non-randomised comparative study of 229 patients.

2.4.3 The Specialist Advisers considered theoretical adverse events to include pain, tendon rupture, haematoma and nerve damage.

2.5 Other comments

2.5.1 NICE received 30 completed questionnaires from patients treated by the procedure. Thirty percent (9/30) stated that they would not have ESWT again; 3 reported that the procedure had made their condition worse with increased pain and decreased mobility. The remaining 70% (21/30) of patients would recommend this procedure to others.

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 an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2 For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

August 2010

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

_{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}