What is the evidence for efficacy, effectiveness and safety of surgical interventions for plantar fasciopathy? Protocol for a systematic review

• Published in: BMJ open 2019-10, Vol.9 (10), p.e031407-e031407
• Main Authors: MacRae, C Siân, Roche, Andrew J, Sinnett, Tim J, O'Connell, Neil E
• Format: Article
• Language: English
• Subjects: Ambulatory care; Ankle; Clinical medicine; Clinical practice guidelines; Clinical trials; Evidence-based medicine; foot & ankle; Intervention; Pain; plantar fasciopathy; Quality of life; Questionnaires; Risk factors; Surgery; Systematic review
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2019-031407

IntroductionPlantar fasciopathy (PF) is a degenerative condition of the plantar fascia, secondary to repetitive overloading. For the majority, PF is self-limiting with greater than 80% of those affected gaining complete resolution within 1 year. However, persistent symptoms develop in approximately 10% of cases. Clinical practice guidelines for first-line treatment of PF recommend conservative management. For people with persistent symptoms that have not resolved following a trial of 6–12 months of conservative management, surgery may be offered. However, to date there are no systematic reviews of the effectiveness of the various surgical procedures for PF. We aim to systematically review quantitative studies assessing the effectiveness of surgical interventions in the management of PF.Methods and analysisWe will search for all published and unpublished randomised clinical trials evaluating surgical interventions in the management of PF. Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE (OVID), EMBASE (OVID), Web of Science (ISI) and Google Scholar will be searched without restrictions on date or language of publication. Inclusion criteria will include people over 18 years, diagnosed by clinical examination with PF, or with an alternative diagnostic label (eg, plantar fasciitis, plantar heel pain, plantar fasciosis). The primary outcomes are changes in pain severity/intensity for first-step pain, and incidence and nature of adverse events. Secondary outcomes include foot and ankle-related disability/function, health-related quality of life, cost-effectiveness, changes in other reported measures of pain (eg, overall pain) and medication use. Outcomes will be assessed (1) short term (≤3 months after intervention), (2) medium term (>3 months to ≤6 months after intervention) or (3) long term (>6 months to ≤2 years after treatment). All data extraction will be performed by at least two independent reviewers on the basis of a priori developed extraction form. Where adequate data are found meta-analysis will be used to combine the results of studies for all core comparisons and outcomes using random effects models. Overall certainty of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationThis systematic review does not require ethical approval as primary data will not be collected. The results of the study will be publishe