Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the efficacy and safety of extracorporeal shockwave therapy for the treatment of people with peripheral arterial disease.
Background
Description of the condition
Peripheral arterial disease (PAD) is an atherosclerosis‐induced disease that affects non‐cardiac and non‐intracranial arteries (Enns 2014). It is characterised by lesions in the innermost layer of arteries, including the aorta and its branches, to the extremities. Risk factors include smoking, hyperlipidaemia, and hypertension (Dormandy 1999; Fowkes 2008; Hooi 2004; Pande 2011). It can severely affect quality of life and life expectancy (Bentham 2018). Peripheral arterial disease is very common in men over 50 years old, and affects approximately eight million people in the United States (Hirsch 2001). The number of people living with PAD has increased in the past decade, particularly in low‐ and middle‐income countries (Forbes 2010). Data indicate that the incidence of PAD increases with age, reporting an incidence of 5.9% in people over 40 years old and 22.4% at age 80 years or older (Gregg 2004; Pande 2011). Peripheral arterial disease is generally not a direct cause of death, but it remains a leading cardiovascular cause of morbidity, and may result in prolonged inpatient stays, which places a substantial burden worldwide (Emdin 2015). The earliest and most common symptom of PAD is intermittent claudication (cramping leg pain when walking), which is relieved by rest. People with PAD often experience poor health‐related quality of life (Dumville 2004; Wu 2017). Therefore, one of the main goals of treatment for PAD is to relieve symptoms and improve quality of life. Current therapy for PAD comprises drugs, exercise, open bypass surgery and endovascular therapy, where drugs and endovascular therapy are the most common treatment (Au 2013). There is evidence that non‐invasive treatments are more easily accepted by people with PAD, and have fewer side effects compared with non‐invasive treatment (Williams 2016).
Description of the intervention
Extracorporeal shockwave therapy (ESWT) is a relatively new approach to the treatment of PAD. A shockwave is a transient acoustic pulse with a high peak pressure, and different energy values and frequencies are used to treat different diseases (Mittermayr 2012). The shockwave system is targeted at the gastrocnemius muscles of the affected lower leg, for several minutes at each PAD treatment session. It has been widely used in sports medicine (Lohrer 2010; Sems 2006; Wang 2003), and ESWT has become the established main treatment for many sports‐related conditions (Perez 2003; Thomson 2005; Wilner 2004). Numerous studies have demonstrated increased expression of vascular endothelial growth factors (VEGFs) after treatment with ESWT (Nishida 2004; Wang 2003; Zhang 2014). Following initial findings, further explorations of ESWT have been carried out; the majority of published papers (from randomised controlled trials to animal experiments) report that this technique can improve blood flow in the microcirculation in ischaemic tissues (Aicher 2006; Elster 2010; Wang 2001; Xu 2009). In recent years, ESWT has been used to treat PAD (Ciccone 2012; Green 2018; Tara 2014). A study from Nippon Medical School has shown that ESWT can effectively and safely increase microcirculatory blood flow in people with PAD (Tara 2014). A study in Italy has shown that ESWT can relieve pain in people with critical limb ischaemia (Belcaro 2005). Extracorporeal shockwave therapy has also been shown to improve the healing rate of ischaemic ulcers (Hitchman 2019; Wang 2015), and improved the walking ability of people with PAD, without any adverse effects (Serizawa 2012).
How the intervention might work
Studies have shown that ESWT can promote angiogenesis, which improves the local blood supply and physiological function of ischaemic tissue, while using 10% of the energy of traditional extracorporeal shockwave lithotripsy (used in breaking down kidney stones) (Aicher 2006; Fukumoto 2006; Wang 2011). Mechanical stimulus from ESWT has been shown to activate VEGF signalling and elicit angiogenesis (Luu 2013; Zebda 2012). Extracorporeal shockwave therapy can also induce the up‐regulation of angiopoietin‐1, thereby promoting microvascular maturation and stabilization, and further promoting focal adhesion kinase (FAK) activation to enhance angiogenesis (Braren 2006; Cascone 2005). Extracorporeal shockwave therapy can increase the expression of endothelial nitric oxide synthase (eNOs), so improving blood flow by relaxing blood vessels, and reducing oxidative stress, thereby promoting angiogenesis and tissue repair (Aicher 2006). ESWT has been demonstrated to have an anti‐inflammatory effect, with upregulation of eNOS activity and subsequent suppression of NF‐kappaB activation. In endothelial denudation models, ESWT has been demonstrated to suppress neointimal proliferation and reduce smooth muscle proliferation. These are potential mechanisms by which ESWT could retard or regress atherogenesis (Frairia 2011). Data suggest that the beneficial effects of ESWT on the walking ability of people with PAD may be attributed to enhancement of several intrinsic angiogenic pathways (Serizawa 2012). ESWT can increase blood flow in limbs by stimulating the formation of collateral circulation within them and delaying the process of arteriosclerosis in lower limbs, thus alleviating symptoms (Raza 2017).
Why it is important to do this review
Several authors have published systematic reviews focusing on ESWT for orthopaedic diseases and urological conditions (Barratt 2017; Fankhauser 2015; Roerdink 2017), and there have been a number of clinical studies on ESWT in the treatment of PAD. Despite this, its application in the field of PAD has not widely acknowledged by the medical community. In this review, we will summarise the available evidence for the effect of ESWT on PAD, to determine its effectiveness and safety. We believe this research will help vascular surgeons make decisions about whether or not ESWT can be used as an adjunct to PAD treatment.
Objectives
To assess the efficacy and safety of extracorporeal shockwave therapy for the treatment of people with peripheral arterial disease.
Methods
Criteria for considering studies for this review
Types of studies
We will include all randomised controlled trials (RCTs) that examine extracorporeal shockwave therapy (ESWT) for peripheral arterial disease (PAD).
Types of participants
We will include participants, men and women of any age, diagnosed with PAD (intermittent claudication and critical limb ischaemia). We will include trials in which the diagnosis of PAD is based on relevant clinical examination (ankle brachial index (ABI), duplex ultrasonography, computed tomography angiography or magnetic resonance angiography).
Types of interventions
We will include studies that use any type of ESWT intervention, alone or as an adjunct to standard medical care for PAD. We will compare this to a control group that receives standard medical care alone (without ESWT), or a control intervention other than ESWT. Both treatment groups must have equal use of any co‐interventions, so that we can attribute any treatment effect to ESWT.
Types of outcome measures
Primary outcomes
Pain‐free walking distance or time (PFWD/T) on treadmill
Maximum walking distance or time (MWD/T) on treadmill
Quality of life, as measured using validated quality of life scales (such as EQ‐5D or Short Form (SF‐36))
Amputation‐free survival
Secondary outcomes
Ankle brachial index (ABI)
Complete healing of ulceration
Pain (measured using any validated scales, such as the numerical rating scale (NRS), verbal rating scale (VRS), or Visual Analogue Scale (VAS)
All‐cause mortality
Adverse events related to ESWT (such as exacerbation of pain, redness of the skin, local haematoma)
We will report the time points reported by the included trials.
Search methods for identification of studies
Electronic searches
The Cochrane Vascular Information Specialist aims to identify all relevant RCTs, regardless of language or publication status (published, unpublished, in press, or in progress).
The Information Specialist will search the following databases for relevant trials:
the Cochrane Vascular Specialised Register via the Cochrane Register of Studies (CRS‐Web);
the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO);
MEDLINE (Ovid MEDLINE Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE Daily and Ovid MEDLINE; 1946 onwards);
Embase Ovid (from 1974 onwards);
CINAHL Ebsco (from 1982 onwards).
The Information Specialist has devised a draft search strategy for RCTs for MEDLINE (displayed in Appendix 1), and will use this as the basis for search strategies for the other databases listed.
The Information Specialist will search the following trials registries:
ClinicalTrials.gov (www.clinicaltrials.gov);
World Health Organization International Clinical Trials Registry Platform (www.who.int/trialsearch).
Searching other resources
We will review the reference lists of all major studies, and review the included studies for additional references. We will contact relevant experts to identify any unpublished research, or publications of a study in non‐indexed journals.
Data collection and analysis
Selection of studies
Two review authors (WF, NL) will independently screen the titles and abstracts identified by searches. If there is any disagreement in screening decisions, a third author (BY) will arbitrate. We will retrieve the full‐text publications of all studies that appear to meet the inclusion criteria. Two review authors (WF, NL) will independently screen the full texts to identify those studies that meet the inclusion criteria, and will record the reasons for the exclusion of ineligible studies. We will resolve any differences through discussion or consultation with a third reviewer (SL). We will record the selection process in sufficient detail to complete the PRISMA flow chart (Liberati 2009). We will provide reasons for exclusion in the 'Characteristics of excluded studies' table.
Data extraction and management
Two review authors (WF, NL) will independently extract data from eligible studies. We plan to extract data including:
study authors' names;
publication date;
study design, randomisation methods, details of blinding;
study population (mean age, age range, gender distribution, diagnostic criteria, baseline characteristics);
information on the shockwave intervention (including duration and dose) and control intervention;
outcome measures and efficacy evaluation indicators, follow‐up time;
reports on adverse reactions.
We will resolve disagreements by consensus, or by involving a third person (BY). One review author (SL) will transfer data into Review Manager 5 (Review Manager 2014).
Assessment of risk of bias in included studies
Two review authors (FW, NL) will independently assess the risk of bias in included studies according to Cochrane's 'Risk of bias' tool (Higgins 2011). We will resolve any disagreement by consultation with a third author (BY). The evaluation will include the following seven aspects:
random sequence generation (selection bias);
allocation concealment (selection bias);
blinding of participants and personnel (performance bias);
blinding of outcome assessment (detection bias);
incomplete outcome data (attrition bias);
selective reporting (reporting bias); and
any other sources of bias.
We will assess each item as being at one of three risk levels (low risk, unclear risk, or high risk).
Measures of treatment effect
We will report measures of treatment effects for dichotomous outcomes as risk ratios (RR) with 95% confidence intervals (CI). For continuous outcomes we will report mean difference (MD) with 95% CIs. We will report standardised mean difference (SMD) with 95% CI if different studies use different measurements for the same outcome, such as different pain scales. To be able to combine the data of the studies using different scales or outcome measures (e.g. different treadmill protocols such as graded tests and workload tests), we will base the data of the treatment effect on the ratio (or per cent change) of the benefit on ESWT and placebo or control (or other active) treatment relative to the baseline. For the outcome 'amputation‐free survival' we will pool hazard ratios using the generic inverse variance facility in Review Manager 5 (Review Manager 2014).
Unit of analysis issues
The unit of analysis will be participants, as randomised to the intervention and control groups.
Dealing with missing data
We will record missing and unclear data for each included study. If possible, we will perform all analyses using an intention‐to‐treat approach. We will contact study authors to request missing data if necessary.
Assessment of heterogeneity
We will analyse statistical heterogeneity with the Chi2 test (P value < 0.10), and use the I2 statistic to measure heterogeneity. We will consider I2 > 50 % to indicate heterogeneity among studies. If we determine substantial or considerable heterogeneity (I2 > 50 %), we will report and explore possible causes, based on prespecified subgroup analysis.
Assessment of reporting biases
We will investigate reporting bias using funnel plot analysis, if the number of included trials is more than 10, as described in the Cochrane Handbook for Systematic Reviews of InterventionsHiggins 2011. An even distribution of studies on either side of the vertical line of the combined RR value indicates no reporting bias.
Data synthesis
We plan to carry out data analysis using Review Manager 5 (Review Manager 2014). We will assess heterogeneity, and use a fixed‐effect model to combine statistical effects if we identify little or no heterogeneity. If we measure heterogeneity as I2 > 50%, which indicates substantial or considerable heterogeneity, we will use a random‐effects model to combine the data. If we do not consider the data to be appropriate for a meta‐analysis, we will carry out a narrative synthesis.
Subgroup analysis and investigation of heterogeneity
We plan to carry out the following subgroup analyses.
PAD stage (intermittent claudication versus critical limb ischaemia)
Dose of ESWT (different energy values and frequencies)
Treatment sessions of ESWT (duration of sessions)
Presence or absence of diseases, such as cardiovascular, cerebrovascular and metabolic‐related, mainly for lower extremity orthopedic diseases and diabetes, because these are known causes of PAD.
We will use the formal test for subgroup interactions in Review Manager 5 (Review Manager 2014).
Sensitivity analysis
We will use sensitivity analysis to determine if the results of our analyses are robust. We will exclude studies with a high risk for bias from the pooled analysis, and perform the analysis again to assess the impact of these studies on the results. We will consider a study to be at high risk of bias if it has two or more domains that we deemed to be at high risk of bias using the Cochrane 'Risk of bias' tool.
Summary of findings and assessment of the certainty of the evidence
We will create a 'Summary of findings' table using the following outcomes: PFWD/T, MWD/T, quality of life, adverse events, ABI, complete healing of ulceration, and pain severity. We will use the five GRADE considerations (risk of bias, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of the body of evidence as it relates to the studies which contribute data to the meta‐analyses for the prespecified outcomes (Atkins 2004). We will use the methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), and use GRADEpro software (GRADEPro GDT 2015). We have created a draft 'Summary of findings' table (Table 1).
Table 1.
Summary of findings
| Extracorporeal shockwave therapy for peripheral arterial disease | ||||||
|
Patient or population: people with PAD Settings: hospital Intervention: ESWT Comparison: standard medical care 1 | ||||||
| Outcomes | Anticipated absolute effects * (95% CI) | Relative effect (95% CI) | No. of Participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard medical care | Risk with ESWT | |||||
|
PFWD/T (follow up) |
Study population | value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
|||
| The mean PFWD/T ranged across control groups from [value][measure] | The mean PFWD/T in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] |
|||||
|
MWD/T (follow up) |
Study population | value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
|||
| The mean MWD/T ranged across control groups from [value][measure] | The mean MWD/T in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] |
|||||
|
Quality of life (measured on validated quality of life scale, follow up) |
Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
|||
| The mean QoL ranged across control groups from [value][measure] | The mean QoL in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] | |||||
|
Amputation‐free survival (follow‐up) |
Study population | HR [value] ([value] to [value]) | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
||
| [value] per 1000 | [value] per 1000 ([value] to [value]) | |||||
|
ABI (follow up) |
Study population | RR [value] ([value] to [value]) | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
||
| [value] per 1000 | [value] per 1000 ([value] to [value]) | |||||
|
Complete healing of ulceration (follow up) |
Study population | RR [value] ([value] to [value]) | value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
||
| [value] per 1000 | [value] per 1000 ([value] to [value]) | |||||
|
Pain (measured on validated pain scale, follow up) |
Study population | [value] ([value]) | [Delete as appropriate] ⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high |
|||
| The mean pain severity ranged across control groups from [value][measure] | The mean pain severity in the intervention groups was [value] [lower/higher] [(value to value lower/higher)] | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ABI: ankle brachial index; CI: confidence interval; ESWT: extracorporeal shockwave therapy; HR: hazard ratio; MWD/T: maximum walking distance/time; PAD: peripheral arterial disease; PFWD: pain‐free walking distance/time; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Standard medical care, such as antihypertensive drugs and hypoglycaemic agents, or any other control intervention
Acknowledgements
The authors, and the Cochrane Vascular Editorial base, are grateful to the following peer reviewers for their time and comments. Associate Professor Andrew Holden, Auckland City Hospital, Auckland, New Zealand Associate Professor Anthony Leicht, James Cook University, Townsville, Australia
Appendices
Appendix 1. MEDLINE search strategy
1 Arterial Occlusive Diseases/
2 Arteriolosclerosis/
3 Arteriosclerosis Obliterans/
4 Arteriosclerosis/
5 Atherosclerosis/
6 exp Femoral Artery/
7 exp Iliac Artery/
8 exp LEG/bs
9 exp Peripheral Vascular Diseases/
10 exp Popliteal Artery/
11 exp Tibial Arteries/
12 Intermittent Claudication/
13 Ischemia/
14 Vascular Diseases/
15 ((aort* or iliac or femoral or popliteal or femoro* or fempop* or crural) adj3 (obstruct* or occlus*)).ti,ab.
16 (arter* adj (occlus* or steno* or obstuct* or lesio* or block* or obliter*)).ti,ab.
17 (atherosclero* or arteriosclero* or PVD or PAOD or PAD).ti,ab.
18 (claudic* or hinken*).ti,ab.
19 (isch* or CLI).ti,ab.
20 (leg adj4 (obstruct* or occlus* or steno* or block* or obliter*)).ti,ab.
21 (limb adj4 (obstruct* or occlus* or steno* or block* or obliter*)).ti,ab.
22 (lower adj3 extrem* adj4 (obstruct* or occlus* or steno* or block* or obliter*)).ti,ab.
23 (peripher* adj (occlus* or steno* or obstuct* or lesio* or block* or obliter*)).ti,ab.
24 (peripheral adj3 dis*).ti,ab.
25 (vascular adj (occlus* or steno* or obstuct* or lesio* or block* or obliter*)).ti,ab.
26 (vein* adj (occlus* or steno* or obstuct* or lesio* or block* or obliter*)).ti,ab.
27 (veno* adj (occlus* or steno* or obstuct* or lesio* or block* or obliter*)).ti,ab.
28 arteriopathic.ti,ab.
29 or/1‐28
30 exp Extracorporeal Shockwave Therapy/
31 "HIFU therapy".ti,ab.
32 "High intensity focused ultrasound therapy".ti,ab.
33 ECSW.ti,ab.
34 ESWT.ti,ab.
35 "shock wave*".ti,ab.
36 "shockwave*".ti,ab.
37 or/30‐36
38 29 and 37
39 randomized controlled trial.pt.
40 controlled clinical trial.pt.
41 randomized.ab.
42 placebo.ab.
43 drug therapy.fs.
44 randomly.ab.
45 trial.ab.
46 groups.ab.
47 or/39‐46
48 exp animals/ not humans.sh.
49 47 not 48
50 38 and 49
Contributions of authors
WF: conceived the idea and drafted the protocol BY: conceived the idea and drafted the protocol NL: reviewed and revised the draft protocol SL: reviewed and revised the draft protocol
Sources of support
Internal sources
No sources of support supplied
External sources
-
Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.
The Cochrane Vascular editorial base is supported by the Chief Scientist Office.
Declarations of interest
WF: none known BY: none known NL: none known SL: none known
Notes
Parts of the methods section of this protocol are based on a standard template established by Cochrane Vascular.
New
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