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van CCT (UK)

van CCT (UK)

‘The (cost) effectiveness of orthotic insoles for plantar fasciitis’

- candidate number22539
- NTR NumberNTR5346
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2015
- Secondary IDsNL 52185.078.15 MEC-2015-253
- Public Title‘The (cost) effectiveness of orthotic insoles for plantar fasciitis’
- Scientific TitleTreatment of Fasciitis Plantaris in General Practice and Sports Medicine. STAP-study
- hypothesisCustom made orthotic insoles by a podiatrist are (cost)effective in reducing pain and improving function in patients with plantar fasciitis compared to sham orthotic insoles and education alone.
- Healt Condition(s) or Problem(s) studiedPlantar fasciitis
- Inclusion criteria- Age 18-65 years
- Minimal pain duration of 2 weeks
- Patients with plantar fasciitis, characterized as pain at the medial hind foot, presenting themselves to a general practitioner of sports physician
- 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,
- Tarsal tunnel syndrome,
- Stress fractures, infections or tumours
- Systemic disease (such as Bechterew, Psoriasis or MS)
- No understanding of the Dutch language
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-sep-2017
- Target number of participants185
- InterventionsThe intervention group will receive custom made orthotic insoles from a participating podiatrist. One control group will receive a sham orthotic insole from a podiatrist while another control group will receive usual care only. All groups will receive education.
- Primary outcomePain at rest and during activity (11-point NRS scale) after 12 weeks follow-up
- Secondary outcomeFoot function (FFI) after 12 and 26 weeks follow-up
- Recovery (measured on a 7-point Likert scale ranging from “completely recovered” to “worse than ever”. Patients are deemed to be recovered if they rate themselves as “fully recovered” or “strongly recovered” on the Likert scale, whereas those who rate themselves as “slightly recovered” to “worse than ever” are deemed to be not recovered) after 12 and 26 weeks follow-up
- Pain at rest and during activity (11-point NRS scale) after 26 weeks follow-up
- Cost-effectiveness of the intervention after 26 weeks follow-up
- TimepointsSubjects will be asked to complete questionnaires at baseline, 2, 4, 6, 12 and 26 weeks follow-up.
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESDr. M. Middelkoop, van
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale
Plantar fasciitis is a common cause of foot pain that typically affect middle aged or older people but is also frequently seen in athletes. Many intervention strategies are applied in patients with plantar fasciitis; biomechanical treatment (including footwear modification like orthotic insoles) being one of the most applied. However the effectiveness of orthotic insoles has never been supported by high quality randomized controlled trials.
To examine the effectiveness of custom made orthotic insoles compared to sham insoles and usual care only in patients with plantar fasciitis in general practice and sports medicine practices.
Study design
The STAP study is a three-arm randomized controlled trial with a 26-week follow-up. Inclusion will be performed by general practitioners and sports physicians in the Netherlands.
Study population
Patients with complaints of fasciitis plantaris with a minimal duration of 2 weeks and aged between 18 and 65 are eligible for inclusion.
Patients allocated to the intervention group will receive a custom made insole from a participating podiatrist. The first control group will receive a sham insole from a podiatrist and participants allocated to the second control group will receive usual care only by their general practitioner or sports physician. All groups will receive education.
Main endpoints
Pain during rest and activity after 12 weeks.
- Main changes (audit trail)
- RECORD5-aug-2015 - 25-aug-2015

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