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Comparison between types of stretching ortheses in treatment of plantar fasciitis


- candidate number29263
- NTR NumberNTR7407
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2018
- Secondary IDs18-053  METC ZWH
- Public TitleComparison between types of stretching ortheses in treatment of plantar fasciitis
- Scientific TitleComparison between different types of gastrocnemius-soleus stretching in the treatment of plantar fasciitis: posterior tension night splint, soft night splint or a custom-made cast.Monocenter randomized trial.
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedNight splint, Cast, Gastrocnemius-soleus stretching, Plantar fasciitis
- Inclusion criteriaEngels
Age over 18 years
Patient with, the subjective and objective signs and symptoms of mechanical plantar fasciitis
Patients who speak and/or understand Dutch
Patient who are able and willing to participate in a treatment for 6 months.

Nederlands
Patienten ouder dan 18 jaar
Patienten met objectieve en subjectieve symptomen van mechanische fasciitis plantaris
Patienten die Nederlands spreken en verstaan
Patienten die de mogelijkheden hebben en bereidt zijn om een behandeling te ondergaan voor 6 maanden.
- Exclusion criteria Engels
Subject is not able to complete the daily questionnaires in Dutch or not being able to fill in the Dutch Questionnaires.
Patients with heel pain from causes other than plantar fasciitis
Patients with a history of heel fracture or heel surgery, and systemic inflammatory arthritis.
Subject, in the opinion of the investigator, is not able to understand this investigation and is not willing and able to perform all study procedures and co-operate with investigational procedures.
Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
Subject has refused voluntary, written informed consent to participate in this randomized controlled trial

Nederlands
Patienten die niet in staan zijn om de Nederlandse vragenlijsten in te vullen of te begrijpen
Patienten met hiel pijn vanwege een andere oorzaak dan fasciitis plantaris
Patienten met een voorgeschiedenis van calcaneusfractuur, calcaneus operaties of systeemaandoening waardoor artritis..
Patient die niet in staat is mo het onderzoek te begrijpen en niet capabel is om aan het onderzoek en de procedure te voldoen,
Patienten die medicatie neemt in verband met spieraandoening waardoor de mobiliteit is aangedaan tgv stijfheid en pijn zoals fibromyalgie en polymyalgia.
Patienten die weigeren een informed consent formulier te ondertekenen.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2018
- planned closingdate1-okt-2020
- Target number of participants104
- InterventionsTreatment of plantar fasciitis with:
Group 1: Prefabricated posterior tension night splint (Pro Orthics)
Group 2: Prefabricated soft night splint (Strassburg sock)
Group 3: Custom made cast
- Primary outcomeTo assess the clinical outcome and evaluate the effectiveness after treatment of plantar fasciitis with a posterior tension night splint (Pro Orthics), soft night splint (Strassbourg sock) or custom made cast for the treatment of plantar fasciitis in a monocenter routine clinical setting.

Our primary endpoint is pain measured with a Numeric Rating Scale (NRS first step pain) at 3 months after starting treatment between the three stretching orthesis.
- Secondary outcomesecondary endpoints are the NRS (pain in rest) at three and six months, Foot Function Index (FFI), Foot and Ankle outcome scores (FOAS), compliance and satisfaction questionnaire. These are foot specific questionnaires specifically designed to measure outcome after ankle-foot treatment.
- TimepointsOur primary endpoint is pain measured with a Numeric Rating Scale (NRS first step pain) at 3 months after starting treatment between the three stretching orthesis. Patient wil be followed till six months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES I.C.E. Bouman
- CONTACT for SCIENTIFIC QUERIES I.C.E. Bouman
- Sponsor/Initiator Haga Hospital, Department of Orthopedics
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- Publications
- Brief summaryPlantar fasciitis is the most common cause of subcalcaneal heel pain. It is a condition that affects about 10% of the population, frequently with an onset in middle-aged individuals, and accounts many orthopedic outpatient visits due to limited physical activity. Plantar fasciitis is often treated with a stretching ortheses in addition to stretching exercises of the calf musculature. There have been several effective stretching ortheses options mentioned in recent history and frequently prescribed in our hospital such as posterior tension night splint (Pro Orthics), soft night splint (Strassburg sock) and a custom made cast. However, no randomized controlled trials were performed which compares the differences in pain and functional outcome between these three stretching orthesis. The purpose of this randomized study is to evaluate the effectiveness of three conservative options for the treatment of plantar fasciitis in a monocenter routine clinical setting.
- Main changes (audit trail)
- RECORD13-jul-2018 - 10-aug-2018


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