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KSR Number: KSRA87242

Comparison of efficacy of shock-wave therapy versus corticosteroids in plantar fasciitis: a meta-analysis of randomized controlled trials

Risk of Bias Assessment

Overall summary: High risk of bias in the review

Bottom Line

Current evidence suggests that shockwave (SW) therapy may improve pain in adults with plantar fasciitis compared to corticosteroid (CS) therapy. Evidence also suggests CS therapy may improve overall pain and functional scores compared to SW therapy; however, there is a large amount of uncertainty associated with this finding. Finally, evidence suggests no difference in plantar fascia thickness for SW compared to CS therapy. Of note, these conclusions must be interpreted with caution, since several methodological issues mean that relevant studies may have been missed and substantial (unexplained) heterogeneity was present in all pooled analyses. Further large, well-designed randomised controlled trials are needed to provide further evidence to compare the long-term efficacy of SW and CS in adults with plantar fasciitis.

Risk of Bias Assessment

Overall summary High risk of bias in the review

High

Authors acknowledged that studies may have been missed due to the restriction to the English language. They also acknowledged the presence of heterogeneity due to the variance of populations, disease duration and outcome scores in the limitations. A full search strategy was not reported, therefore it was not possible to assess if this was adequate. There was no information provided on whether searches were restricted by date, publication format or language. Pre-defined sensitivity analyses were not reported for all relevant outcomes.

A. Did the interpretation of findings address all of the concerns identified in Domains 1 to 4? Probably no
B. Was the relevance of identified studies to the review's research question appropriately considered? Probably yes
C. Did the reviewers avoid emphasizing results on the basis of their statistical significance? Probably yes
Risk of bias in the review High

Details of Review

Number of studies 6
Number of participants 454
Last search date May 2018
Review type Intervention
Objective To evaluate if shock-wave (SW) therapy is superior to corticosteroids (CS) in managing plantar fasciitis, both in terms of ameliorating pain as well as improving functionality.
Population Adults (over 18 years) with plantar fasciitis.
Interventions Shock-wave (SW) therapy.
Comparator Corticosteroid (CS) therapy.
Outcome Pain and functional outcomes.
Study design Randomised controlled trials (RCTs).

Results

In terms of pain score, pooled analysis reported a reduction in visual analogue scale (VAS) pain score for SW therapy compared to CS therapy at 3 months (MD -0.96, 95% Cl -1.28 to -0.63; 4 studies, n=354 patients).

In terms of composite scores based on pooled pain and functional subscales (based on either the Mayo clinical scoring system (CSS), the foot function index (FFI), HFI or 100 scoring system), pooled analysis reported an improved score for corticosteroid (CS) therapy compared to shockwave (SW) therapy at 3 months; however, this was associated with a large amount of uncertainty (mean difference [MD] 3.83, 95% confidence interval [CI] -0.57 to 8.22; 4 studies, n=289 patients).

In terms of plantar fascia thickness (PFT), pooled analysis reported no difference in PFT for SW compared to CS therapy at 3 months (MD 0.10, 95% CI -0.06 to 0.26; 3 studies, n=157 patients).

Full Risk of Bias Assessment

The research objective was clearly stated and appropriate inclusion criteria were defined. No restrictions were imposed based on study characteristics. Studies were restricted based on language (only English language studies were included).

1.1 Did the review adhere to pre-defined objectives and eligibility criteria? Probably yes
1.2 Were the eligibility criteria appropriate for the review question? Probably yes
1.3 Were eligibility criteria unambiguous? Probably yes
1.4 Were all restrictions in eligibility criteria based on study characteristics appropriate (e.g. date, sample size, study quality, outcomes measured)? Probably yes
1.5 Were any restrictions in eligibility criteria based on sources of information appropriate (e.g. publication status or format, language, availability of data)? Probably no
Concerns regarding specification of study eligibility criteria High

PubMed, Medline, Embase, the Cochrane Library and Clinicaltrials.gov were searched for relevant studies. No further strategies to identify additional studies were reported. A full search strategy was not reported. There was no information as to whether searches were restricted by date, publication format or language. Two investigators were independently involved in the study selection process and any disagreements between them were resolved with a discussion or through the intervention of a third researcher.

2.1 Did the search include an appropriate range of databases/electronic sources for published and unpublished reports? Probably yes
2.2 Were methods additional to database searching used to identify relevant reports? Probably yes
2.3 Were the terms and structure of the search strategy likely to retrieve as many eligible studies as possible? No information
2.4 Were restrictions based on date, publication format, or language appropriate? No information
2.5 Were efforts made to minimise error in selection of studies? Yes
Concerns regarding methods used to identify and/or select studies Unclear

Two authors were independently involved in the data extraction process and any disagreements were resolved by a third reviewer. Sufficient study characteristics appear to have been extracted to allow for the interpretation of the results. Relevant study results appear to have been extracted. Methodological quality of the included studies was assessed using the modified Jadad scale. Risk of bias was assessed using the Cochrane risk of bias tool for randomised controlled trials. Two authors were independently involved in the risk of bias assessment and any disagreements were resolved by discussion to reach a consensus or by a third investigator.

3.1 Were efforts made to minimise error in data collection? Yes
3.2 Were sufficient study characteristics considered for both review authors and readers to be able to interpret the results? Probably yes
3.3 Were all relevant study results collected for use in the synthesis? Probably yes
3.4 Was risk of bias (or methodological quality) formally assessed using appropriate criteria? Yes
3.5 Were efforts made to minimise error in risk of bias assessment? Yes
Concerns regarding methods used to collect data and appraise studies Low

The synthesis appeared to include all eligible studies. The method of analysis was explained and appeared appropriate. Heterogeneity was assessed and found to be moderate or high for all outcomes. Sensitivity analyses were only narratively described for some outcomes, and the numerical results of the single sensitivity analysis were not formally presented. The quality of the individual studies was considered in the synthesis.

4.1 Did the synthesis include all studies that it should? Probably yes
4.2 Were all pre-defined analyses reported or departures explained? Probably no
4.3 Was the synthesis appropriate given the degree of similarity in the research questions, study designs and outcomes across included studies? Probably no
4.4 Was between-study variation minimal or addressed in the synthesis? Probably no
4.5 Were the findings robust, e.g. as demonstrated through funnel plot or sensitivity analyses? No information
4.6 Were biases in primary studies minimal or addressed in the synthesis? Probably yes
Concerns regarding synthesis and findings High

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