Objectives To compare custom-made insoles to sham insoles and general practice (GP)-led usual care in terms of pain at rest and during activity at 12 weeks follow-up in individuals with plantar heel pain.
Methods In this randomised clinical trial 185 patients aged 18 to 65 years, with a clinical diagnosis of plantar heel pain for at least 2 weeks, but no longer than 2 years were recruited. Patients were randomly allocated into three groups: (1) GP-led treatment, plus an information booklet with exercises (usual care; n=46), (2) referral to a podiatrist for treatment with a custom-made insole plus an information booklet with exercises (custom-made insole; n=70) and (3) referral to a podiatrist and treatment with a sham insole plus an information booklet with exercises (sham insole; n=69). As well as the primary outcome of pain severity (11-point Numerical Rating Scale) we used the Foot Function Index (0 to 100) as a secondary outcome.
Results Of 185 randomised participants, 176 completed the 12-week follow-up. There was no difference in pain or function between the insole and the sham groups at 12 weeks. Participants in the GP-led usual care group reported less pain during activity at 12 weeks, (mean difference (MD) 0.94, 95% CI 0.23 to 1.65), less first step pain (MD 1.48, 95% CI 0.65 to 2.31), better function (MD 7.37, 95% CI 1.27 to 13.46) and higher recovery rates (RR 0.48, 95% CI 0.24 to 0.96) compared with participants in the custom insole group.
Conclusions Referral to a podiatrist for a custom-made insole does not lead to a better outcome compared to sham insoles or compared to GP-led usual care.
Trial registration number NTR5346.
- general practice
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Contributors NR contributed to the study design, recruitment of participants, management of study proceedings, data collection and drafting and revision of the manuscript. LF, MM, SBZ and PB contributed to the study conception and design, and drafting and revision of the manuscript. MR and PV contributed to study design and reviewed the manuscript. AD reviewed and revised the manuscript. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding This trial is funded by The Netherlands Organisation for Health Research and Development (ZonMW) under number: 839110008. The Dutch Association of Podiatrist (NVvP) funded the intervention provided to patients in the insole and the sham group.
Disclaimer The funders of the study had no role in conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript or the decision to submit for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval This trial adhered to the principles of the Declaration of Helsinki and the medical ethical committee of the Erasmus Medical Centre has approved the study (MEC: 2015–253).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. All data are available upon reasonable request.
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