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INTERVENTIONAL PROCEDURES PROGRAMME
Interventional procedure overview of 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. It is not known exactly how this works, but it is thought that it might stimulate healing. Introduction
The National Institute for Health and Clinical Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared
This overview was prepared in September 2010. Procedure name
• Extracorporeal shockwave therapy for refractory greater trochanteric pain Specialty societies
• British Orthopaedic Association • British Hip Society • British Society of Skeletal Radiologists. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Description
Indications and current treatment
Greater trochanteric pain syndrome is a disorder that affects the (lateral) side of the hip or hips. Greater trochanteric pain may be associated with inflammation of the trochanteric bursa (also known as trochanteric bursitis). The trochanteric bursa is a small fluid-filled sac that separates the greater trochanter of the femur and the overlying fascia lata to allow smooth movement. Greater trochanteric pain may also be associated with direct injury, tendon damage, infection, differences in leg length or hip-replacement surgery. Greater trochanteric pain syndrome is usually managed conservatively with rest, physiotherapy, anti-inflammatory medication and corticosteroid injections. Surgical approaches such as supratrochanteric fasciotomy or bursectomy can also be used if conservative treatments fail to relieve the symptoms. The mechanism by which shockwave therapy might have an effect on greater trochanteric pain syndrome is not well defined. What the procedure involves
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 may be used to assist with positioning of the device. The shockwaves are generated using electrohydraulic, electromagnetic or piezoelectric energy. The patient is placed in the lateral decubitus position and ultrasound gel is applied to the skin overlying the greater trochanter and peritrochanteric region. Treatment protocols for ESWT vary according to the energy density and frequency of shockwaves. ESWT is delivered in a lateral to medial direction and may be applied in a series of treatments or a single session. Local anaesthesia may be administered to the patient before treatment because high-energy ESWT can be painful. Instruments used to assess efficacy
A visual analogue scale (VAS) is used to measure pain on a scale from 0 to 10 (0 = no pain, 10 = severe pain). A 2-point change is considered to be clinically significant. The Harris hip score was originally a hip replacement evaluation tool. This tool assesses pain, function and functional activities from 0 to 100. A 10-point change in score is considered to be clinically significant. Higher scores indicate improvement. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome The Roles and Maudsley score is a subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pre-treatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pre-treatment). Literature review
Rapid review of literature
The medical literature was searched to identify studies and reviews relevant to extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome. Searches were conducted of the following databases, covering the period from their commencement to 22 April 2010 and updated 28 September 2010: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. Table 1 Inclusion criteria for identification of relevant studies
Characteristic
Criteria
Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patients with refractory greater trochanteric pain syndrome (chronic greater trochanteric bursitis). Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome List of studies included in the overview
This overview is based on 295 patients from 2 non-randomised comparative studies1,2. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Table 2 Summary of key efficacy and safety findings on extracorporeal shockwave therapy for refractory greater
trochanteric pain syndrome
Abbreviations used: IP; interventional procedures; NR, not reported; NS, not significant; RCT, randomised controlled trial; SWT, shock wave therapy; VAS, visual analogue scale Study details
Key efficacy findings
Key safety findings
Comments
Number of patients analysed: 229 (78 vs 75 vs 76)
Adverse reactions until 1 month follow-up Follow-up issues:
Comparative study
Recovered /improved (patients who selected 1 [completely recovered] or (sequential allocation)
Study design issues:
n = 229 (78 vs 75 vs 76)
All adverse reactions described as mild. Return to previous levels of sporting/recreational activity at 4 months IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Abbreviations used: IP; interventional procedures; NR, not reported; NS, not significant; RCT, randomised controlled trial; SWT, shock wave therapy; VAS, visual analogue scale Study details
Key efficacy findings
Key safety findings
Comments
rotation ≤ 20° and presence (Shockwave vs injection: p < 0.05, shockwave vs home training: p < 0.001 and injection vs home training: p = NS) Additional treatment during 4-15 month follow-up Comparison of use of additional treatment: 80.3% (61/76) of patients in the home-training group reported continuing be done twice a day every
day for 12 weeks).
Follow-up: 15 months
Conflict of interest/source
of funding: none
IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Abbreviations used: IP; interventional procedures; NR, not reported; NS, not significant; SWT, shock wave therapy; VAS, visual analogue scale Study details
Key efficacy findings
Key safety findings
Comments
Number of patients analysed: 66 (33 vs 33)
Follow-up issues:
VAS (mean pain score)
Non-randomised comparative study
Study population: patients with chronic greater trochanteric pain syndrome (moderate to severe pain located over the greater trochanter and peritrochanteric p < 0.001 for each time point for SWT and control group compared area, pain with resisted hip abduction and impaired Mean Harris Hip score
Study design issues:
n = 66 (33 vs 33)
Age: SWT group: 51 years (mean); control group: 50.2 Sex: SWT group: 66.7% (22/33) female; control group: p < 0.001 for each time point for SWT compared with pre- Patient selection criteria: inclusions: patients with an Mean Roles and Maudsley score
established diagnosis for 6 months for whom at least 3 types of traditional non-operative measures for a minimum of 6 months have failed. Exclusions: < 18 years old, rheumatoid arthritis, polyarthritis, local infection, pregnancy, bleeding disorders, tumours, prior hip surgery and unresolved hip, pelvis or lumbar vertebrae fractures. All patients had anteroposterior % of patients with excellent or good scores (1 or 2) after Study population issues:
pelvic and lateral radiographs to rule out end-stage hip treatment was significantly greater in the SWT group than the control group at each time point (p < 0.001). In both the SWT and controls groups, no patient reported Technique: low-energy radial shockwave therapy worsening of symptoms compared with baseline. (1 session using Swiss DolorClast, 2000 pulses applied with pressure of 4 bar equal to 0.18 mJ/mm2, Return to preferred sporting activity at pre-injury level
10 shocks per second) vs control group (non-operative Return to occupation requiring extensive physical
Follow-up: 12 months
activity
Conflict of interest/source of funding: none IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Efficacy
Recovery/symptom improvement
A non-randomised comparative study of 229 patients (78 ESWT vs 75 single local corticosteroid injection vs 76 home training) reported an increased proportion of patients who had either completely recovered or had improved symptoms (assessed using a 6-point Likert scale, 1 = completely recovered and 6 = much worse) following ESWT at 1 month (13% [10/78]), 4 months (68% [53/78]) and 15 months (74% [58/78]) after treatment. In the corticosteroid injection group, 75% (56/75) reported complete recovery or improved symptoms at 1 month, which dropped to 51% (38/75) at 4 months and to 48% (36/75) at 15 months. The home-training group reported an increased proportion of patients who had either completely recovered or had improved symptoms following treatment at 1 month (7% [5/76]), 4 months (41% [31/76]) and15 months (80% [61/76]). The non-randomised comparative study of 229 patients reported significantly higher mean pain scores (measured on a visual analogue scale from 0 to 10; 10 indicates worst conceivable pain) in the ESWT (5.6) and the home-training groups (5.9) compared to the injection group (2.2, p < 0.001) at 1 month. However, the reverse was reported at 15 months with ESWT (2.4) and home-training (2.7) groups reporting significantly lower pain scores than the injection group (5.3, p < 0.001). All groups reported similar pain scores (range 5.8–6.3) at baseline1. A non-randomised comparative study of 66 patients (33 ESWT vs 33 non-operative therapy) reported significantly lower mean pain scores (measured on a visual analogue scale) in the ESWT group compared to the non-operative therapy group at 12-month follow-up (2.7 vs 6.3, p < 0.001). Both groups reported mean pain scores of 8.5 at baseline2. Harris hip score
The non-randomised comparative study of 66 patients reported significantly higher mean Harris hip scores (measured on a scale from 0 to 100; high scores indicate improvement) in the ESWT group compared to the non-operative therapy group at 12 month follow-up (79.9 vs 57.6, p < 0.001). The groups reported similar mean Harris hip scores at baseline (ESWT: 49.6 and non-operative therapy: 50.4, p value not reported)2. Roles and Maudsley score
The non-randomised comparative study of 66 patients reported a significantly higher proportion of patients with excellent or good scores (1 or 2 on the Roles IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome and Maudsley scale) in the ESWT group compared with the non-operative therapy group at 1, 3 and12 month follow-up (p < 0.001)2. Return to sport/recreational activities
The non-randomised comparative study of 229 patients reported 64% (50/78) of the ESWT group, 49% (37/75) of the injection group and 34% (26/76) of the home-training group returned to previous sporting or recreational activity at 4 months (ESWT vs injection, p < 0.05 and ESWT vs home training, p < 0.001)1. The non-randomised comparative study of 66 patients reported 76% (13/17) of the ESWT group and 67% (10/15) of the non-operative therapy group returned to previous sporting activity at pre-injury level. The same study reported that 88% (7/8) of patients in the ESWT group and 83% (5/6) of patients in the non-operative therapy group returned to an occupation requiring extensive physical activity2. Safety
The non-randomised comparative study of 229 patients reported 46% (36/78) of the ESWT group, 44% (33/75) of the injection group and 65% (49/76) of the home-training group had no adverse reactions up to 1-month follow-up (injection vs home training p < 0.05 and home training vs ESWT p < 0.05). All adverse reactions were described as mild1. Pain related to the procedure
The non-randomised comparative study of 229 patients reported 2% (2/78) of the ESWT group, 24% (18/75) of the injection group and 20% (15/76) of the home-training group had increased pain for more than 1 day1. Skin irritation
The non-randomised comparative study of 229 patients reported 33% (26/78) of the ESWT group and 3% (2/75) of the injection group had irritated skin within 1 month of follow-up1. The non-randomised comparative study of 66 patients reported transitory skin reddening that resolved without intervention in 2 patients. It is assumed that these patients were in the ESWT group, but this is not explicitly stated in the paper2. Validity and generalisability of the studies
• The quantity of evidence was limited. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome • One paper claimed to be a randomised controlled trial but did not randomise patients to the 3 study treatments. Patients in the comparative study of 66 • The extracorporeal shockwave treatment protocols were different in the 2 Existing assessments of this procedure
There were no published assessments from other organisations identified at the time of the literature search. Related NICE guidance
Below is a list of NICE guidance related to this procedure. Appendix B gives details of the recommendations made in each piece of guidance listed. Interventional procedures
• Extracorporeal shockwave therapy for refractory plantar fasciitis. NICE interventional procedures guidance 311 (2009) Available from • Extracorporeal shockwave therapy for refractory Achilles tendinopathy. NICE interventional procedures guidance 312 (2009). Available from • Extracorporeal shockwave therapy for refractory tennis elbow. NICE interventional procedures guidance 313 (2009). Available from Specialist Advisers’ opinions
Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and does not represent the view of the society. Professor Nicola Maffulli (British Orthopaedic Society) and Mr David Silver (British Hip Society/British Society of Skeletal Radiologists) • Both Specialist Advisers perform this procedure regularly. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome • Both Specialist Advisers describe this procedure as the first in a new class of procedure with fewer than 10% of specialists engaged in this area of work (one of the Specialist Advisers also considers the procedure to be established • The Specialist Advisers thought that theoretical adverse events include pain, tendon rupture, haematomas and neuronal damage. • Anecdotal adverse events: tenderness, bruising and haematoma. • The Specialist Advisers considered key efficacy outcomes to be a degree of recovery measured on 6-point Likert scale, severity of pain measured on a • The Specialist advisers recommended training in machine operation and administration of ESWT (given by the supplier). • One Specialist Adviser states that there is controversy due to lack of robust data on efficacy, although the procedure is considered safe. Patient Commentators’ opinions
NICE’s Patient and Public Involvement Programme sent 60 questionnaires to 1 trust for distribution to patients who had the procedure (or their carers). NICE The Patient Commentators raised the following issues about the safety and efficacy of the procedure which did not feature in the published evidence or the opinions of Specialist Advisers, and which the Committee considered to be Thirty percent (9/30) of patients stated that they would not have ESWT again: 3 patients 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. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome References
Rompe JD, Segal NA, Cacchio A et al. (2009) Home training, local corticosteroid injection, or radial shockwave therapy for greater trochanter pain syndrome. American Journal of Sports Medicine 37: 1981–90. Furia JP, Rompe JD, Maffulli N. (2009) Low-energy extracorporeal shockwave therapy as a treatment for greater trochanteric pain syndrome. American Journal of Sports Medicine 37: 1806–13. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Appendix A: Additional papers on extracorporeal
shockwave therapy for refractory greater trochanteric
pain syndrome
The following table outlines the studies that are considered potentially relevant to the overview but were not included in the main data extraction table (table 2). It is by no means an exhaustive list of potentially relevant studies. Number of
Direction of
Reasons for
patients/follow-up
conclusions
non-inclusion
in table 2
treatment of the trochanteria bursitis with tendinosis of the gluteus. Available from Patients assessed with Roles and Maudsley score and VAS. Peled E, Norman D, Levin D et al. (2006) Israeli Orthopaedic Association (conference ultrasound and one steroid injection).failed in all patients. Patients received 6 courses of ESWT (1500 impulses) Mean VAS dropped from 7.9 to 1.6 (p = 0.001). No side effects except minimal local discomfort during session time. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome Appendix B: Related NICE guidance for extracorporeal
shockwave therapy for refractory greater trochanteric
pain syndrome
Guidance
Recommendations
Extracorporeal shockwave therapy for refractory plantar fasciitis.
NICE interventional procedures guidance 311 (2009)

1 Guidance
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/IPG311publicinfo). 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, including a
description of local anaesthesia use and the type of energy applied
(see section 2.5). 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.
Extracorporeal shockwave therapy for refractory Achilles
tendinopathy. NICE interventional procedures guidance 312 (2009)
1 Guidance
1.1 The evidence on extracorporeal shockwave therapy (ESWT) for
refractory Achilles tendinopathy raises no major safety concerns:
there have been reports of occasional tendon rupture in treated
patients, but this may also occur when the procedure has not been
used. However, current evidence on efficacy of the procedure is
inconsistent. Therefore, ESWT for refractory Achilles tendinopathy
should only be used with special arrangements for clinical governance,
consent and audit or research.
IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome 1.2 Clinicians wishing to undertake ESWT for refractory Achilles tendinopathy 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 about its safety in relation to a possible risk of tendon rupture, 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/IPG312publicinfo). Audit and review clinical outcomes of all patients having ESWT for refractory Achilles tendinopathy (see section 3.1). 1.3 NICE encourages further research into ESWT for refractory Achilles
tendinopathy. Future research should take the form of clinical studies
with clearly described patient selection and treatment protocols,
including a description of local anaesthesia use and the type of energy
applied (see section 2.5). 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.
Extracorporeal shockwave therapy for refractory tennis elbow.
NICE interventional procedures guidance 313 (2009)
1 Guidance
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/IPG313publicinfo). 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, including a description of local anaesthesia use and the type of energy applied (see section 2.5). 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.
IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome
Appendix C: Literature search for extracorporeal
shockwave therapy for refractory greater trochanteric
pain syndrome
Database
Date searched
Version/files
Systematic Reviews – CDSR (Cochrane Library) Database of Abstracts of Reviews of Effects – DARE (CRD website) HTA database (CRD website) Controlled Trials – CENTRAL (Cochrane Library) MEDLINE (Ovid) only)
MEDLINE search strategy
The following search strategy was used to identify papers in MEDLINE. A similar
strategy was used to identify papers in other databases.
1 (((shockwave* or shockwave*) adj5 therap*or treatment*) or lithotrip*).tw. 7 ((high-energ* or (high adj5 energ*) or ultraso*) adj5 shock* adj5 wave*).tw. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome 16 (adhesive adj capsuliti* adj5 (hip* or coxa*)).tw. IP overview: extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome

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