Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Plantar Fasciitis: a Double-blind Randomized Clinical Trial

Обзор

This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the foot muscles and stretching the plantar fascia and posterior chain, hyperthermia on the plantar fascia insertion area in the calcaneus and adjacent areas, and the use of an orthotic insole used for walking. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure local pain using an algometer, assess ankle joint range of motion, and use ultrasound imaging techniques. Subjective variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations in patients with lower limb pathologies, lower limb functional assessment, and a visual analogue scale for pain perception.

Вмешательства

• Лучевая терапия Hyperthermia
  Hyperthermia will be applied for a period of 15 to 20 minutes in the area to be treated, maintaining a thermal sensation of gentle heat for the patient and accompanied by active-assisted or passive mobilization of the structures adjacent to the plantar fascia.
• Другое Physical Exercise
  The therapeutic physical exercise focused on the flexor muscles of the foot will consist of 3 periods of isometric contraction of 15 seconds, with a rest period of 30 seconds, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.
• Другое Stretching
  The plantar fascia stretch will be performed with the patient in the supine position. Maximum dorsiflexion will be achieved, and the lower limb will be elevated with the knee extended as tolerated. This procedure will be performed three times in a row for 30 seconds, with a 1-minute rest between each stretch.
• Другое Orthopedic insole
  Imposition of an orthopedic insole

Первичные конечные точки

• FOOT AND ANKLE ABILITY MEASURE (FAAM) [Срок оценки: Baseline and up to one year]
• LOWER EXTREMITY FUNCTIONAL SCALE (LEFS) [Срок оценки: Baseline and up to one year]
• International Physical Activity Questionnaire (IPAQ) [Срок оценки: Baseline and up to one year]
• Visual Analogue Scale (VAS) [Срок оценки: Baseline and up to one year]
• PRESSURE PAIN THRESHOLD (PPT) [Срок оценки: Baseline and up to one year]
• WEIGHT-BEARING LUNGE TEST (WBLT) [Срок оценки: Baseline and up to one year]
• Ultrasonography [Срок оценки: Baseline and up to one year]

Критерии участия

Критерии включения

• Have a diagnosis confirmed by performing an ultrasonography of Plantar Fascitis
• Have not yet received physiotherapy treatment.

Критерии исключения

• Have undergone surgery.
• Those who refuse to participate in this study.
• Patients with muscle atrophy due to plantar fasciitis.
• Medical conditions that are contraindications for hyperthermia therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07103226 · 139/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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