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Research project

STAP study: Soles as Treatment Against Pain in feet

Status: Ongoing (2015-2020)

A RCT in patients with plantar heel pain assessing the (cost)effectiveness of custom insoles by a podiatrist, compared to sham and usual care by the GP.

What we do

About our project

Background
Plantar heel pain is a common foot complaint in Dutch primary care. Referral to a podiatrist for a custom insole is a common intervention provided to these patients by the GP. Yet, evidence for the (cost)effectiveness of this intervention is lacking.

Hypothesis
We hypothesize that treatment with a custom insole by a podiatrist is more effective in reducing heel pain compared to treatment with a sham insole by a podiatrist or to usual care by the GP.

Methods
A total of 185 patients aged 18-65 years with plantar heel pain who contacted their GP and have had complaints for a minimum of 2 weeks and a maximum of 2 years will be included. Patients will be randomly allocated to referral to a participating podiatrist for treatment with a custom insole, referral to a participating podiatrist for treatment with a sham insole or to usual care by the GP. The effect of treatment will be evaluated by questionnaires at 2, 4, 6, 12, and 26 weeks after allocation. Patients referred to a podiatrist will undergo a standardized examination during the first appointment. Statistical analysis will be based on the intention-to-treat a principle.

Our research focus

Primary outcome
The primary outcome is to examine the effectiveness of custom made orthotic insoles by a podiatrist, compared to sham orthotic insoles and usual care by the general practitioner or sports physician in patients with plantar fasciitis in terms of pain, function and recovery.

Secondary outcomes
The secondary outcome is to examine the cost effectiveness of custom made orthotic insoles by a podiatrist, compare to sham orthotic insoles and usual care by the general practitioner or sports physician in patients with plantar fasciitis.

Funds & Grants

ZonMw HGOG (839110008).

Collaborations

  • The Dutch Association of Podiatrist (NVvP)
  • Department of Sports Medicine, MC Haaglanden
  • Aalborg University, Denmark

Publications

1. Rasenberg N, Bierma-Zeinstra SM, Bindels PJ, van der Lei J, van Middelkoop M. Incidence, prevalence, and management of plantar heel pain: a retrospective cohort study in Dutch primary care. Br J Gen Pract. 2019 Oct 21.

2. Rasenberg N, Riel H, Rathleff MS, Bierma-Zeinstra SMA, van Middelkoop M. Efficacy of foot orthoses for the treatment of plantar heel pain: a systematic review and meta-analysis. Br J Sports Med. 2018 Aug;52(16):1040-1046.

3. Rasenberg N, Fuit L, Poppe E, Kruijsen-Terpstra AJ, Gorter KJ, Rathleff MS, van Veldhoven PL, Bindels PJ, Bierma-Zeinstra SM, van Middelkoop M. The STAP-study: The (cost) effectiveness of custom made orthotic insoles in the treatment for plantar fasciopathy in general practice and sports medicine: design of a randomized controlled trial. BMC Musculoskelet Disord. 2016 Jan 16;17:31. PMC4715321.

Our team

M. van Middelkoop (co-promotor), m.vanmiddelkoop@erasmusmc.nl
M.S. Rathleff, misr@hst.aau.dk
L. Fuit, lfuit@sportpodotherapie.nl
E. Poppe, e.popper@podotherapie.nl
A. Dieker, amy.dieker@podotherapie.nl
K.J. Gorter, gorterkj@telfort.nl
P.H.J. van Veldhoven, p.van.veldhoven@haaglandenmc.nl
P.J.E. Bindels, p.bindels@erasmusmc.nl
S.M.A. Bierma-Zeinstra (promotor), s.bierma-zeinstra@erasmusmc.nl

Contact address for the project: n.rasenberg@erasmusmc.nl.