Clinical Trial Details
— Status: Unknown status
Administrative data
| NCT number |
NCT01882894 |
| Other study ID # |
PFO Trial |
| Secondary ID |
|
| Status |
Unknown status |
| Phase |
N/A
|
| First received |
June 17, 2013 |
| Last updated |
June 20, 2013 |
| Start date |
September 2013 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
June 2013 |
| Source |
University of Puget Sound |
| Contact |
Robert E Boyles, PT, DSc |
| Phone |
253-879-3633 |
| Email |
bboyles[@]pugetsound.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this randomized control trial is to identify the possible effectiveness of the
temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).
Description:
A. Background Plantar fasciitis is the most common foot complaint in America, affecting
approximately 10% of people during their life time.9 It can be a painful and debilitating
condition which appears in both sedentary and active populations. A survey performed by the
Foot and Ankle Special Interest Group of the Orthopedic Section, APTA, found that 100% of
therapists reported PF as the most common foot condition seen in their clinic. 9
Approximately one million patients visit physicians for the diagnosis and treatment of
plantar fasciitis.10 Chronic plantar fasciitis, previously thought to be an inflammatory
condition caused by repetitive microtearing of the plantar fascia, is now thought to be a
degenerative condition.5 The plantar aponeurosis, or fascia, functions to provide static
support of the longitudinal arch and dynamic shock absorption. It consists of 3 bands:
lateral, medial, and central. The central band originates from the medial tubercle of the
calcaneus and travels across the metatarsal heads to the phalanx of each toe.9 In the acute
stage, pain is commonly localized to the origin of the medial and central bands at the
plantar surface of the calcaneus.6 This pain is usually classified as a sharp or knife-like
pain upon initial standing. The pain occurs after a period of non-weight bearing and is often
the worst in the morning. Those in the chronic stages may report pain as being dull and achy.
Pain in this stage may also extend beyond the medial tubercle, extending into the central and
lateral bands. Pain at this stage does not usually subside after a few minutes of walking as
seen in the acute phase.6 Many factors contribute to the development of plantar fasciitis.
Anatomy, biomechanics and environment are factors which contribute to the development of this
condition.6 Pes planus, pes cavus feet, limited dorsiflexion, tight Achilles tendon, tight
hamstrings and obesity fall beneath anatomical causations. Biomechanical factors include weak
plantar flexor muscles and excessive subtalar joint pronation. Environmental factors include
weight bearing activities, foot wear and trauma.6 Certain diseases also place an individual
at increased risk. These may include diabetes, peripheral vascular neuropathy, Paget's
disease, Reiter's syndrome, and other autoimmune and neurologic disorders.8 Diagnosis is
mostly made upon clinical assessment and findings for classifying a patient with heel pain
into the International Statistical Classification of Diseases and Related Health Problems
category of plantar fasciitis and associated International Classification of Functioning
Disability and Health impairment based category of heel pain.9 To date, there is no specific
treatment of choice for patients with plantar fasciitis. Multiple studies have been conducted
on various conservative treatment techniques but according to Crawford et al's Cochrane
Review, "There is limited evidence upon which to base clinical practice." 1 The options
include: modalities, manual therapy, stretching, taping, night splints, steroid injections
and orthotic devices. Of all the previous interventions, there is strong evidence to support
the use of orthotic devices to provide temporary relief of symptoms.9 Traditional orthotic
devices are designed and casted with the subtalar and midtarsal joints in a neutral position.
They are hypothesized to limit excessive pronation, optimize biomechanical loading of the
foot, and off load the plantar fascia.10 Additionally, custom orthotics are costly and may
require the specialty services of an orthotist to cast the individual. Despite the cost and
time-intensive manufacturing process, custom orthotics are often worn for life and may prove
to be ineffective after 3 months.9 A recent pilot study proposed the benefit of temporary
foot orthoses casted in equinos position for plantar fasciitis treatment.2,3 As opposed to
the traditional casting method of subtalar and midtarsal joints in neutral, the equinos
position places the patient's foot in full plantar flexion and inversion. This casting
position is hypothesized to put the plantar fascia in a slackened position, therefore
reducing weight-bearing on the damaged tissue.2 Consequently, the aim of this randomized
control trial is to identify the possible effectiveness of the temporary use of an
inexpensive custom-made plantar fascia orthotic (PFO), fabricated in equinos position of the
foot.
B. Project Description Prior to study commencement a training session will be provided to
educate and ensure all investigators are able to perform examination, casting and accurately
provide instruction to all participants. All investigators will also be trained in
distribution and analysis of all outcome measures to be used in the study.
The study will begin with subjects completing a medical screening questionnaire. All subjects
will then go through a formal physical examination that is conducted by one of the
investigators. Subjects meeting the criteria for admission and consenting to participate in
the study, will sign an informed consent form, and be included in the study. Subjects will be
assigned to a control or experimental group via a random number generator. Subjects will then
complete two outcome measures to collect baseline data, the Foot and Ankle Ability Measure
(FAAM) and a Numeric Pain Rating Scale (NPRS). The FAAM has been shown to be a valid and
reliable self-reported outcome measure of lower leg, ankle, and foot function of a range of
musculoskeletal disorders in a physical therapy setting. The FAAM asks patients to rate level
of difficulty in several activities of daily living and in sport specific activities. The
NPRS asks patients to rate the intensity of first step heel pain on scale of 0-10, with 0
equal to no pain and 10 equal to worst pain ever experienced. Additionally, a GRC has been
shown to be a valid and reliable method of assessing changes in quality of life over time. A
Global Rating of Change (GRC) will be collected throughout the study (baseline, two weeks,
four weeks, twelve weeks, and six months). Upon initial evaluation, researchers will also
complete a Foot Posture Index (FPI-6) for each subject to classify static foot posture in a
standing position. The FPI-6 looks at multiple bony landmarks of the foot in a full
weight-bearing position and gives each landmark a score based on its position during
standing. A total score is produced to describe the patient's foot type.
Following collection of baseline data, one of the researchers will begin fabricating the
individuals in the experimental group for a custom-made PFO. The custom-made PFO will be
completed by placing subject's foot in the equinos (plantar flexed and inverted) position.
The custom-made PFO will be created from Aqua-Plast casting material. After heating the
Aqua-Plast material, researchers will drape the material over their forearm to ensure that it
isn't too hot for the subject. When the orthosis is hardened, the subject will place it in
his/her shoe (after removing any shoe liners). Researchers will trim, stretch, or pad the
orthosis as needed to make sure it is completely comfortable. If the orthosis is rubbing or
is otherwise found to be uncomfortable, the rough edges will be reheated and smoothed with a
finger or a grinder will be used to taper the edges. Subjects will be told to come in at any
time to make any needed changes. Full instructions for construction of the custom-made PFO
will be included.
Control group subjects will be asked to wear a faux orthotic that will be constructed of a
soft material that will cushion, but not support, the plantar fascia. Subjects will be asked
to wear either the PFO or faux orthotic at all times while weight bearing for a two week time
frame during the initial treatment period. An exception will be made for showering, in which
the subjects will be instructed to weight-bear on the lateral side of the foot to avoid
pronation and pulling on the plantar fascia. After two weeks, subjects will be weaned off of
the orthotic for one week. Weaning includes wearing orthotic 8 hours per day, following a
stretching program that includes a Windlass (plantar fascia) stretch with soft tissue
mobilization and calf stretch, and ankle range of motion exercises.
The plantar fascia stretch will consist of the patient sitting and placing his/her affected
foot crossed over the opposite knee and then using his/her hand to pull the toes and ankle
back towards the anterior surface of the lower leg. Once in position the patient will
continue to hold the stretch and apply deep pressure to the plantar fascia from heel to toe
with his/her fingers, thumbs, or knuckles. This activity will be carried out for three
minutes.2 For the gastrocnemius and soleus stretch, the patient will stand 46-61cm away from
a wall, place his/her hands on the wall at shoulder level, and then bend the knee of the
uninvolved leg, while extending the leg of the involved side so that the foot is about 30cm
back. Keeping the back knee straight, the patient will lean slowly in to the wall while
maintaining his/her heel on the floor and hold this stretch for 30 seconds. This stretch will
be repeated four times per session.
Ankle range of motion exercises will be completed prior to the patient getting out of bed
each morning and will consist of the patient: dorsiflexing and plantar flexing his/her ankle
on the involved side, with the knee straight and with the knee bent, ten times in each
position; and performing clockwise and counter-clockwise ankle circles ten times in each
direction.
Participant's outcome indicators will be recorded at the end of two weeks, four weeks, twelve
weeks, and six months following casting. The following outcome measures will be used: NPRS,
FAAM, FPI-6, and GRC. Subjects will be seen in the clinic for the initial exam, two, four,
and twelve week follow-up intervals, with the final six month follow-up conducted via e-mail,
telephone, and postal mail, per the subject's preference.
C. Subject Recruitment Convenience sampling will be implemented in selecting up to 60
subjects from a population of individuals with chronic plantar fasciitis who have either
received, or not received treatment in the previous three months for the same condition.
Following IRB approval, clinical sites, running stores and university campus will be
solicited for recruitment of participants. Inclusion for our sample will include: age 18
years or older, able to tolerate the physical examination and treatment procedures, symptoms
greater than four weeks, able to read, write, and speak sufficient English to be able to
complete the outcome tools, plus two of three of the following: symptom reproduction with
palpation of the proximal plantar fascia insertion and/or mid substance of plantar fascia,
positive Windlass test and/or first step pain after period of inactivity. A positive Windlass
test consists of symptom reproduction when the first metatarsophalangeal joint is placed into
passive extension while the patient is in a standing position. Exclusion criteria for our
sample will include: current symptoms consistent with a lumbar radiculitis, radiculopathy, or
myelopathy, history of foot or ankle fracture with or without the presence of hardware from
an open reduction internal fixation, positive tarsal tunnel syndrome test, known or suspected
pregnancy, and systemic Rheumatic disease, or those undergoing litigation for any medical
condition.
D. Confidentiality of Data The subjects will be carefully screened so as to eliminate any
possible risks from the protocol. The screening, evaluation and treatment will be performed
by physical therapists or senior physical therapy students fully trained to perform all
procedures under their scope of practice. As is the standard of practice, the investigator
will communicate with the subject during the entire process to ensure that each subject is
informed throughout the treatment protocol. All records will be kept confidential per HIPAA
and university operating procedures. No personal identifying information about any subject in
the study will be released to anyone. Data will be secured in locked rooms and on computers
that are password-protected and only accessible to the investigators in the study. In the
unlikely event of an adverse response to treatment, subjects will be provided appropriate
physical therapy and medical intervention.
E. Risk to Subjects The effect of custom-made orthotics fabricated with Aquaplast for the
treatment of plantar fasciitis is not well documented in the literature. However, this is a
non-invasive, patient-directed treatment with minimal known risks, and considered safe and
ethical practice. A faux orthotic is also a low-risk treatment method that does not pose any
risk to the health of control subjects. Risks would include blisters and abrasions from the
orthotic rubbing on the foot and soreness or pain associated with the changes of joint
alignments due to the orthotic. The subjects will be instructed to return immediately, or
call the researchers, if there is any pain associated with the wear of either orthotic.
F. Benefits Experimental participants will benefit from this study by receiving treatment
that will attempt to eliminate, or significantly reduce, heel pain associated with plantar
fasciitis, which may yield an effective, non-invasive, treatment strategy to eliminate the
symptoms associated with plantar fasciitis. Upon completion of the study subjects in the
control group will be offered the PFO, if results show significant improvement for the
experimental group. All subjects in the experimental group will be able to keep their PFO's.
