Clinical randomized comparative study of the treatment of chronic plantar fasciitis with shockwave and corticosteroid infiltration

• Grant number: 13/03417-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: May 01, 2013
• End date: December 31, 2014
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Flavio Faloppa
• Grantee: Thiago Sato de Castro
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

The plantar fasciitis is characterized by inflammation in the plantar fascia, a fibrous tissue that connects the heel to the toes. This condition causes a burning pain or a stabbing pain located in the lower medial aspect of the calcaneus, especially during the first steps in the morning or in the beginning of a march after long periods sitting or standing still. About 2 million Americans develop plantar fasciite each year and up to 20% of the population at least do the same once in their lifetime. The diagnosis of plantar fasciitis is based on history and physical examination of a patient with initial complaint of pain in the plantar area of the foot. The plantar medial heel palpation is painful and may increase intensity by forcing dorsiflexion of the toes. Radiografic exams of the heel, ultrasound of the plantar fascia and MRI of the foot are tools to detect the inflammatory process and to assist in detecting infeccious, other inflamatory or tumor lesions. The initial treatment is conservative, based on the use of steroidal and nonsteroidal anti-inflammatory, physiotherapy, use of crutches or orthotics. The surgical treatment is rarely used, and include resection of the heel spur, fasciectomy and neurectomy. An alternative for the treatment of plantar fasciitis therapy is the use of shockwaves, a method that is safe, harmless and may have great analgesic action with a single application. Several studies have shown that the shockwave therapy stimulates neovascularization and collagen production, which is important in the healing process and that allows various clinical applications as treatment of skin wounds, treatment of pseudoarthrosis and soft tissue inflamatory process, including plantar fasciitis. The objective of this study is to evaluate the effectiveness of the use of shockwaves in the treatment of chronic plantar fasciitis compared to treatment with corticosteroid infiltration. This will be done through: pain assessment, based on the visual analogue scale (VAS) of pain in the foot with plantar fasciitis, the hindfoot function analysis, using the questionnaire of the American Orthopaedic Foot and Ankle Society (AOFAS) and with the analysis of quality of life using the Form of Quality of Life questionnaire Short Form 36 (SF-36).It is a primary study, interventional, clinical trial, longitudinal, prospective, analytical, comparative, randomized, controlled, and aiming at testing the effectiveness of treatment with single-masked trial (single blinded trial) conducted at Hospital São Paulo (HSP), Universidade Federal de São Paulo (UNIFESP). Will be included patients with unilateral chronic plantar fasciitis detected by clinical examination and ultrasonography, and who have a history of previous conservative treatment without success. Patients will be divided into 2 groups. The first group will receive treatment with shock waves, and the second group will receive infiltration with corticosteroids and treatment with a simulation of shock waves. The questionnaires for assessing the effectiveness of treatment will be applied in all patients before randomization and in the follow-up at three weeks, six weeks and 12 weeks after treatment, with the scales VAS, AOFAS and SF-36 by different teams who performed the treatment. The primary outcomes of the study will evaluate the patient's pain by VAS, evaluate the function of the hindfoot by AOFAS, and analysis of the quality of life through the application of the SF-36. (AU)