Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Lower Limb: a Double-blind Randomized Clinical Trial

Обзор

This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the lower limb, 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 muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the nerve root of the lumbosacral plexus, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. 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 range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, lower limb function, and a visual analog scale for pain perception.

Вмешательства

• Другое Neuromodulation
  The application of neuromodulation therapy will be carried out with the support of ultrasound visualization on the anatomical area of the target nerve, seeking a motor and/or sensory response with its stimulation.
• 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
  To stretch the muscles involved, perform three periods of maximum tolerable stretching without pain, lasting 20 seconds and resting for 30 seconds.

Первичные конечные точки

• EUROQOL-5D (EQ-5D) [Срок оценки: Baseline and up to one year]
• SHORT FORM 12 HEALTH SURVEY (SF-12) [Срок оценки: Baseline and up to one year]
• LOWER EXTREMITY FUNCTIONAL SCALE (LEFS) [Срок оценки: Baseline and up to one year]
• LOWER LIMB FUNCTIONAL INDEX (LLFI) [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]
• RANGE OF MOTION [Срок оценки: Baseline and up to one year]
• MUSCULAR STRENGTH [Срок оценки: Baseline and up to one year]

Критерии участия

Критерии включения

• Participants in the study will be men and women of working age, diagnosed with musculoskeletal disorders of the lower limb, and who have not yet received physical therapy.

Критерии исключения

• Have undergone surgery.
• Those who refuse to participate in this study.
• Patients who present muscular atrophy in the lower limb due to a pathology of the latter.
• Medical conditions that are contraindications for neuromodulation 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: NCT07165379 · 151/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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