Plantar Fascitis Clinical Trial
Official title:
Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis.
NCT number | NCT03054610 |
Other study ID # | OR15-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | April 2020 |
Verified date | May 2020 |
Source | Universidad Autonoma de Nuevo Leon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with chronic pain in the heel at the insertion of the plantar fascia in the posteroinferior tuberosity of the calcaneus. - Patients who agreed to be part of the study and signed informed consent. - Patients older than 18 years. - Patients with two or more weeks of evolution. Exclusion Criteria: - Patients with another associated pathology such as knee or ankle dysfunction, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, etc. - Neurological abnormalities: mental retardation or some psychiatric abnormality. - Pregnant patients. - Previous surgery on the heel. |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad Autonoma de Nuevo Leon | Monterrey | Nuevo Leon |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Nuevo Leon |
Mexico,
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Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. — View Citation
Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215. — View Citation
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Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2514-22. doi: 10.2106/JBJS.I.01651. — View Citation
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Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Foot and Ankle Disability Index | We decided to include the FADI score because this type of pathology occurs in patients with sports activity and often causes disability in them, Values activities such as standing, walking on flat or uneven surfaces, inclined planes, time without discomfort while walking, and includes a module where sports activities are valued. Also it counts on an evaluation of the pain in foot and ankle. The best result obtained is 136 points. | 6 months | |
Secondary | Maryland Foot Score | Is divided into several sections where pain is assessed, giving 45 points when there is no pain and 0 when there is inability to work, a function that is divided into two sections, walking and daily activities; And a section that evaluates the shape of the foot, the best score is 100, which means that there is no problem with the foot, and the lowest score is 0. | 6 months | |
Secondary | Ankle-Hindfoot Scale | American Foot and Ankle Orthopedic Society | 6 months | |
Secondary | Visual Analogue scale | Values the pain on a numerical scale of 0-10, where 0 means no pain and 10 greater degree of pain experienced by the patient, it is also complemented by a color scale, where green is equal to painless and red is the more intense pain the patient has had. | 6 months | |
Secondary | Measurement of the plantar fascia using ultrasound | Measure the thickness of the plantar fascia at the beginning and end of the protocol, placing the transducer at the insertion site of the plantar fascia. | 6 months | |
Secondary | Body Mass Index | Measure height and weight of patients at the beginning of the protocol. | 15 minutes | |
Secondary | Measure degrees of dorsiflexion | Use a goniometer as a tool to measure degrees of dorsiflexion. | 6 months |
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