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Comparison between types of stretching ortheses in treatment of plantar fasciitis

Comparison 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. - Comparison between different types treatment of plantar fasciitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24109
Enrollment
102
Registered
2018-07-13
Start date
2018-11-02
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Gastrocnemius-soleusstretching Plantar fasciitis: Night splint, Cast Gastrocnemius-soleusstretching fasciitis plantaris Nachtspalk Gips

Interventions

Treatment 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

Sponsors

Reinier Haga Orthopedisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Engels • 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

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.

Design outcomes

Primary

MeasureTime frame
To 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

MeasureTime frame
secondary 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.

Contacts

Public ContactJ.H. Pasma

Reinier Haga Orthopedisch Centrum

onderzoek@rhoc.nl079- 206 5595

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)