Authors
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Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2026
INTERVENTION: This is a prospective, randomized, controlled, two‐arm, double‐blind clinical trial involving patients diagnosed with plantar fasciitis treated at the Orthopedics Outpatient Clinic of the Hospital Universitário Pedro Ernesto (HUPE), Universidade do Estado do Rio de Janeiro (UERJ). The diagnosis of plantar fasciitis will be confirmed by the Windlass Test, performed non‐weight‐bearing (patient seated with feet dependent and knee flexed at 90 degrees) and weight‐bearing (patient in the same position, but with feet resting on a stool, excluding the toes), with passive extension of the toes until the patient's limit of motion or until the patient reports pain at the anteromedial tuberosity of the calcaneus, being considered positive when the patient reports pain during the examination. The study will be double‐blind, in which participants will be unaware of the group to which they have been allocated and the assessors responsible for administering the questionnaires, performing the ultrasound examination, and using the TechBalance device will also be unaware of the participant's allocation. To ensure participant blinding, individuals in the control group will undergo a sham procedure, in which they will be subjected to the same protocol as the intervention group, but with the vibration platform (VP) turned off (frequency of 0 Hz). During the intervention, a device will be attached behind the VP to emit a sound similar to that of the operating equipment, so that participants cannot differentiate between the real intervention and the sham. Biomechanical parameters will be measured using an accelerometer (Digital Accelerometer EMG832WF, EMG System do Brasil, São José dos Campos, SP, Brazil). Participants will be randomly allocated into two groups by lottery using the Research Randomizer software (https://www.randomizer.org). Each patient will receive a sealed brown envelope containing the designation of the group to which they will belong. One researcher will be solely responsible for the randomization process, having no further contact with the research participant at any other time during the study. Participants will be divided into two groups of 60 participants each, totaling 120 participants. Both groups will receive treatment with conventional physiotherapy, supervised by the Physiotherapy Department of the Orthopedics Service of the Hospital Universitário Pedro Ernesto (HUPE), Universidade do Estado do Rio de Janeiro (UERJ), with a frequency of twice a week, including therapies aimed at analgesia, stretching, and muscle strengthening. The Whole‐Body Vibration (WBV) Group will additionally undergo therapy with an activated systemic vibration platform, once a week, at the Laboratório de Vibrações Mecânicas e Práticas Integrativas (LAVIMPI) of the Policlínica Piquet Carneiro, for a period of three months. The Control Group will additionally undergo the same whole‐body vibration protocol, but with the vibration platform turned off (frequency of 0 Hz) and simulated sound emission to maintain blinding, at the same location and with the same f CONDITION: C05.651.869.653 Plantar fasciitis ; Enthesopathy PRIMARY OUTCOME: It is expected a reduction in pain intensity over a 12‐month period, as assessed by the Visual Analogue Scale (VAS), based on a minimum 30% change between pre‐ and post‐intervention measurements. It is expected an improvement in foot and ankle function over a 12‐month period, as assessed by the American Orthopaedic Foot and Ankle Society (AOFAS) scale, based on a minimum 10‐point change between pre‐ and post‐intervention measurements. INCLUSION CRITERIA: Patients aged 18 years or older; with clinical diagnosis of plantar fasciitis; who signed informed consent SECONDARY OUTCOME: It is expected an improvement in health‐related quality of life over a 12‐month period, as assessed by the Medical Outcomes Study 36‐Item Short Form Health Survey (SF‐36), based on a minimum 10% change in the scores of each domain between pre‐ and post‐intervention measurements.
Epistemonikos ID: 745dc456f9f01a27934014ae741502726ea9f942
First added on: Oct 08, 2026