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

• Grant number: 14/25741-6
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: November 01, 2015
• End date: October 31, 2016
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Flavio Faloppa
• Grantee: Renan Gonçalves Leão
• 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 located in the plantar region of the foot whose function is to protect other sensitive structures such as nerves, blood vessels, muscles and tendons and is responsible for maintaining the plantar arch. This condition affects, most commonly, individuals aged between forty and sixty years, with women more affected than men and generally unilateral. Plantar fasciitis was reported to affect about 20% of general population at least once in life. It 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. The diagnosis is based on history and physical examination of a patient with initial complaint of pain in the plantar area of the foot, with a painful palpation of the medial plantar region of the heel. Radiographic exams may acknowledge the presence, or not, of spur in the lower region of the calcaneus, as a consequence of the inflammatory process. The recommended treatment is conservative, which includes the use of nonsteroidal and steroidal anti-inflammatory drugs, physiotherapy, use of crutches and orthotics, and infiltration with corticosteroids. 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 it allows various clinical applications such as treatment of skin wounds, treatment of pseudoarthrosis and soft tissue inflamatory process, including plantar fasciitis. However, there is a significant difference in the outcomes of several studies evaluating the efficacy of this treatment, which reinforces the need for further clinical investigations using solid confirmatory randomized prospective studies. 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 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 the city of São Paulo, Brazil, by the Department of Orthopedics and Traumatology from Universidade Federal de São Paulo, at Hospital São Paulo. This study is going to use the visual analogue scale (VAS) of pain in the foot with plantar fasciitis to assess pain, the questionnaire of the American Orthopaedic Foot and Ankle Society (AOFAS) to analyze hindfoot function and the Form of Quality of Life questionnaire Short Form 36 (SF-36) to analyze the quality of life, before and after the interventions. Will be included patients with unilateral chronic plantar fasciitis detected by clinical examination, ultrasound examination showing inflammation at the insertion of the plantar fascia in the lower region of the calcaneus and a history of previous unsuccessful conservative treatment. There will be two groups in which the patients will be allocated. One of them will receive the treatment with shockwaves; and the other one will receive infiltration with corticosteroids, with a simulation of shockwaves treatment. The questionnaires for assessing the effectiveness of treatment will be applied in all patients before randomization and in the follow-up at 3 weeks, 6 weeks and 12 weeks after treatment, with the questionnaires being applied by different teams from those 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 of the quality of life through the application of the SF-36. (AU)