Plantar Fascitis Clinical Trial
Official title:
Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in
people 40 years of age or older, overweight, sedentary or with intense physical activity. It
is caused by the over-stretching of the plantar fascia, which is a band of connective tissue
that extends to the base of the phalanges. This produces micro-tears more commonly in its
origin in the medial tuberosity of the calcaneus which causes an inflammatory process and
pain. This pain usually occurs when the person gets up in the morning after sleeping or after
sitting for a long time. That is when the fascia is stretched after being in a contraction
position.
There are a great variety of treatments for this pathology, of these, one of the most common
is the use of intralesional steroids, which a weighing that reduces symptomatology in many
cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar
fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are
extracorporeal shock waves, application of platelet-rich plasma and application of botulinum
toxin A intralesional. All of them are accompanied by insoles, night splints and stretching
exercises of the Achilles tendon and the plantar fascia.
Recent studies have shown that the application of botulinum toxin A intralesional in patients
with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity
and presentation time. Decreased inflammation of the plantar fascia has also been
demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is
applied regularly in the muscles to block the release of acetylcholine in the neuromuscular
plaque and obtain its relaxation and not directly in the pain points. We believe that the
botulinum toxin can be applied intralesional currently, since there is information that the
toxin has analgesic and anti-inflammatory effect and not just muscle relaxation.
The aim of our work demonstrate that the use of botulinum toxin A and intralesional
stretching exercises is superior to intralesional steroids and stretching trying to establish
a safer and less painful therapy avoiding complications prior to the application of steroid
application.
Plantar fasciitis represents the most frequent cause of chronic heel pain, usually occurs in
patients 40 years or older, overweight, sedentary or with intense physical activity.
The plantar fascia function is to prevent foot collapse by its anatomical orientation and by
its tensile forces; It originates at the base of the calcaneus and extends distally to the
phalanges. The plantar fascia stretching prevents the displacement of the calcaneus and the
metatarsals and maintains the medial longitudinal arch. Simulates a cable attached to the
calcaneus and metatarsophalangeal joints. The windlass mechanism described by Hicks, for the
action of the plantar fascia is usually explained when a dorsiflexion of the fingers occurs,
this leads to an effective shortening of the length of the plantar fascia causing an
elevation of the arch. The extension of the fingers increases the arch of tension with the
metatarsophalangeal joint as axis or anchor point. The shortening of the plantar fascia
resulting from the dorsiflexion of the hallux is the essence of the windlass mechanism. When
a fasciotomy is performed, this mechanism is lost, decreasing the stability of the arch and
this does not allow a phase of stable terminal stay.
Historically the development of plantar fasciitis is attributed to biomechanical defects such
as hyperpronation, this contributes to excesive mobility of the foot, which increases the
stress applied to the musculofascial structures and soft tissue through an elongation of
plantar fascia. There are other studies that have shown that one of the main factors for the
appearance of this disease is the mechanical overload and it has been reported that the
tension necessary for the rupture of the windlass mechanism ranges from 1.4 to 3.4 of the
body weight of the subject.
There is a great variety of therapies reported for the treatment of this pathology,
intralesional application of steroids, platelet-rich plasma, intralesional botulinum toxin A,
treatments such as extracorporeal shock waves, all of which are assisted by stretching
excercises of the gastrocnemius and sole muscles or stretching of the plantar fascia.
The clinical use of botulinum toxin A has expanded beyond the original indications by its
effects on cholinergic neurons. The increased interest in the potential role to treat
conditions of chronic pain is partially based on the effects of the toxin on the modulation
of the release of substance P, on the calcitonin-related gene peptide and glutamate. On the
other hand, the toxin has shown its effect on the inhibition of inflamatory pain and on the
release of neurotransmitters from primary sensory neurons in a rat model. It also inhibits
peripheral sensitization, which leads to an indirect decrease in central sensitization. It is
unclear whether the treatment of chronic plantar fasciitis with botulinum toxin A works by
causing muscle paralysis or by analgesic anti-inflamatory effects or by both mechanisms. A
combined effect, induction of paresia of the muscles originating in the medial calcaneus
process and direct analgesia due to analgesic anti-inflamatory properties.
We performed a previous study, where we compared the use of botulinum toxin A against
intralesional steroids; The application of botulinum toxin A was performed in the twin and
sole muscle wombs, while dexamethasone was applied in the area of greatest fascia pain.
Patients who received botulinum toxin had a faster and more sustained improvement than
patients who received steroids.
Another common form of treatment for plantar fasciitis is the application of intralesional
steroids; however, there are reports of complications associated with these drugs and one of
the main ones is the rupture of the plantar fascia, which ranges from 2.4% to 5.7% ; Despite
pain relief due to rupture, many patients have other associated complications such as lateral
plantar nerve dysfunction, stress fractures, among others, mainly after 2 applications.
Objective and originality: The aim of our study is to demonstrate that the use of botulinum
toxin A for the treatment of plantar fasciitis is superior to treatment with intralesional
steroids. We try to establish a safer and less painful treatment therapy for the patient,
since the use of steroids is associated with complications. We believe that the botulinum
toxin A can also be applied intralesional, since there is information that indicates that
this toxin has analgesic and anti-inflammatory effect in its local application and not only
by the action of muscle relaxation by blocking the release of acetylcholine at the
neuromuscular junctions.
General objective:
To assess the therapeutic effect of botulinum toxin A in patients diagnosed with plantar
fasciitis.
Hypothesis:
The application of botulinum toxin A presents better results in the treatment of plantar
fascitis than the use of intralesional steroids.
Material and Methods:
All patients who are recruited for the study will be explained regarding the treatment
protocol, and will also sign informed consent prior to inclusion in the study. Measurement of
the plantar fascia using ultrasound and measurement of ranges of movement of ankle flexion,
as well as measuring and weighing patients to know their body mass index. They will be
randomized into one of three treatment groups. Group 1 (control) treatment with 5 ml of
anesthetic (Ropivacaine 7.5%), Group 2 (steroids) application of 1ml of Betamethasone plus 3
ml of local anesthetic and Group 3 (botulinum toxin A) 250 U, in the insertion zone of the
plantar fascia. All patients will receive a detailed explanation of the stretching exercises
of the plantar fascia, as well as their frequency and duration. Afterwards, the patients will
be evaluated by a blinded investigator, at 2 weeks, 1 month, 3 months and 6 months after
infiltration; evaluation scales will be applied: Visual Analogue Scale (EVA), Maryland Foot &
Ankle Score, Foot & Ankle Outcome Score (AOFAS), Foot & Ankle Disability Index (FADI).
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