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…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Primary Objective:
Is there a minimal important difference in pain level (NRS first step pain)
between subjects with plantar fasciitis receiving a posterior tension night
splint (Pro Orthic), soft night splint (Strassburg sock) or custom made cast
after 3 months?
Secondary outcome
Secondary Objective(s):
• Is there a minimal important difference in pain level (NRS first step pain)
between subjects with plantar fasciitis receiving a posterior tension night
splint ((Pro Orthic), soft night splint (Strassburg sock) or custom made cast
after 6 months?
• Is there a minimal important difference in pain level (NRS rest) between
subjects with plantar fasciitis receiving a posterior tension night splint (Pro
Orthic), soft night splint (Strassburg sock) or custom-made cast after 3/6
months?
• Is there a minimal clinical important difference in influences daily
activities based on functional outcome scores (FFI and FOAS) between the three
groups during 3 and 6 months?
• What is the percentage of subject satisfaction after 6 months between the
three study groups?
• What is the percentage of patient*s compliance between the three study groups
based on nights of wearing in the first three months?
• What is the percentage of additional treatment: immobilisation/ local
infiltration with corticosteroid in the three study groups
Background summary
Plantar 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.
Study objective
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 multicenter routine clinical setting.
Study design
Monocenter prospective randomized and controlled study. Inclusion will start in
September 2018, with a maximum follow of 6 months per patient. The study will
be conducted in the Haga Hospital.
Intervention (if applicable): 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
Study burden and risks
We expect no risks associated with participation, due to the nature of the
study (filling out questionnaires). The extra burden placed on patient will
consist of two times completing four questionnaires at baseline and at three
months (T 1) and six months (T2) and a weekly diary for 3 months.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
• 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.
Exclusion criteria
• 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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL65577.098.18 |
| OMON | NL-OMON24109 |