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Are orthotic insoles effective in pain reduction for plantar fasciitis in general practice or sports physician?

Are orthotic insoles effective in pain reduction for plantar fasciitis in general practice or sports physician? - STAP-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45150
Enrollment
185
Registered
2015-07-16
Start date
2015-09-07
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heel spur Plantar fasciitis

Interventions

All patients will receive an information leaflet including stretching and loading exercises that can be performed at home. Patients randomised to either the sham or custom made insole group will vis

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with plantar fasciitis, characterized as pain at the medial hind foot, presenting themselves to a GP or sports physician and aged between 18 and 65 years and a minimal pain duration of 2 weeks are eligible for participation. The diagnosis of plantar fasciitis can be made with reasonable certainty on the basis of clinical assessment alone. Patients typically report a gradual onset of pain in the inferior heel that is usually worse with their first steps in the morning or after a period of inactivity. And secondly there is a localized area of maximal tenderness over the anteromedial aspect of the inferior heel.

Exclusion criteria

Exclusion criteria: Recurrent complaints of plantar fasciitis for more than 2 years; complaints caused by trauma; earlier treatment for plantar fasciitis by a podiatrist or treatment with orthotics; suspected (osteo)arthritis in the subtalar or talonavicular joint; suspicion on tarsal tunnel syndrome, stress fractures, infections or tumours, systemic diseases (Bechterew, psoriasis or multiple sclerosis); no understanding of the Dutch language.

Design outcomes

Primary

MeasureTime frame
After 12 weeks: - pain at rest and during activity (11-point NRS scale)

Secondary

MeasureTime frame
After 6 en 26 weeks: - pain at rest and during activity (11-point NRS scale) - foot function (FFI) - recovery (measured on a 7-point Likert scale ranging from *completely recovered* to *worse than ever*) 26 weeks: - cost-effectiveness of the interventions

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)