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

Обзор

This project aims to analyze the use of hyperthermia within a bursitis treatment protocol, 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 affected joint, stretching of the involved muscles, and the application of hyperthermia to the bursa and surrounding areas. 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: on the one hand, the objective variable will be measurement and assessment of the bursa using ultrasound imaging. Subjective measurement variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations, and the visual analog 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 bursa.
• Другое Physical Exercise
  The therapeutic physical exercise will consist of 3 periods of isometric contraction of 30 seconds, with a rest period of 1 minute, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.
• Другое Stretching
  Stretching of the involved muscles will involve 3 periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Первичные конечные точки

• DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH) [Срок оценки: Baseline and up to one year]
• LOWER EXTREMITY FUNCTIONAL SCALE (LEFS) [Срок оценки: This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity]
• 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]
• Ultrasonography [Срок оценки: Baseline and up to one year]

Критерии участия

Критерии включения

• Have a diagnosis confirmed by performing an imaging test of Bursitis
• Have not yet received physiotherapy treatment.

Критерии исключения

• Have undergone surgery.
• Those who refuse to participate in this study.
• Patients with muscle atrophy.
• 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: NCT07099573 · 140/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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