To examine the effectiveness of custom made orthotic insoles by a podiatrist, compared to sham orthotic insoles and education alone in patients with plantar fasciitis in terms of pain, function and recovery.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After 12 weeks:
- pain at rest and during activity (11-point NRS scale)
Secondary outcome
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
Background summary
In both primary and secondary care, many intervention strategies are applied in
patients with plantar fasciitis. The most frequently studied and applied
treatments include biomechanical treatment (including footwear modification),
stretching, shock wave therapy, and cortisone injections. However, there are
few data from high-quality randomized controlled trials that support the
efficacy of these therapies. A pilot study among 19 general practitioners (GPs)
in the region of Rotterdam shows that during a first visit for foot complaints,
32% of the patients are directly referred to a podiatrist for an orthotic
insole. Another 29% received direct advice for (prefabricated) insoles by their
general practitioner. So orthotic insoles are the most frequent applied
interventions for plantar fasciitis in general practice. Unpublished data shows
that 4% of all consultations are diagnosed by the sports physician with plantar
fasciitis , which corresponds to approximately nine consultations per month.
Previous research has shown that plantar fasciitis is the third most common
running injury. However, there is insufficient evidence that insoles can reduce
pain and improve function in these patients.
Study objective
To examine the effectiveness of custom made orthotic insoles by a podiatrist,
compared to sham orthotic insoles and education alone in patients with plantar
fasciitis in terms of pain, function and recovery.
Study design
Three-arm Randomised Clinical Trial with a follow-up of 6 months
Intervention
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 visit the podiatrist who will proceed
with a standard intake and will execute the same procedure in all patients. All
patients allocated to the intervention group will receive a custom made
orthotic insole while patients allocated to the sham control group will receive
a flat insert (placebo insole). The participants in these two study groups will
be blind to their treatment allocation
Study burden and risks
There are no risks associated with participation. All patients included in our
study will receive the usual care according to the clinical guideline.
The only tests that are used are questionnaires, which will take about 15
minutes each at 2,4,6, 12 and 26 weeks. THe baseline questionnaire will take
about 25 minutes. Altogether this will take the patient approximately 100
minutes over a period of 1/2 year . The questionnaires that are used are not
associated with physical or physiological discomfort. In the intervention
group, patients will. Patients randomised to the sham or custom made insole
group will all be referred to a podiatrist This will take 60 minutes for two
visits.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52185.078.15 |
| OMON | NL-OMON21365 |