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Набор по приглашению NCT06706479

The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain

Без фазы С лечением Chronic Low Back Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: high-definition transcranial direct current stimulation.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain. Базовые параметры: 60 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effects of High-definition Transcranial Direct Current Stimulation on Balance Control in Older Adults With Chronic Low Back Pain: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to investigate the effects and mechanisms of high-definition transcranial direct current stimulation over left dorsolateral prefrontal cortex on chronic low back pain and balance in older adults. The main questions it aims to answer are: Primary hypothesis 1: Active stimulation would have greater improvement in pain and balance, reduced left dorsolateral prefrontal cortex activation than sham stimulation. Primary hypothesis 2: Active stimulation would have enhanced functional connectivity than sham stimulation. Primary hypothesis 3: The balance improvement would be related to reduced pain, decreased left dorsolateral prefrontal cortex activation, enhanced functional connectivity, attention, and/or executive function. Participants will be randomly received a single-session of high-definition transcranial direct current stimulation (active or sham stimulation). Before and immediately after the intervention, balance (semi-tandem stance and timed up-and-go test (TUG)) and cognitive (attention and executive function) tests will be assessed.

Вмешательства

  • Устройство high-definition transcranial direct current stimulation
    High-definition transcranial direct current stimulation is a novel non-invasive brain stimulation technique based on the principle that when weak intensity electric currents are targeted on specific areas of the scalp, they cause underlying cortical stimulation. The anode increases cortical excitability, while cathode decreases cortical excitability.

Первичные конечные точки

  • Current back-pain intensity [Срок оценки: Before and immediately after the intervention.]
Вторичные конечные точки (8)
  • Resting-state blood oxygen concentration [Срок оценки: Before and immediately after the intervention.]
  • Arithmetic performance [Срок оценки: Before and immediately after the intervention.]
  • Postural sway [Срок оценки: Before and immediately after the intervention.]
  • Timed up-and-go test (TUG) [Срок оценки: Before and immediately after the intervention.]
  • Attention [Срок оценки: Before and immediately after the intervention.]
  • Executive function [Срок оценки: Before and immediately after the intervention.]
  • Side or adverse effects [Срок оценки: During and 1 hour after the intervention.]
  • Blinding efficacy [Срок оценки: Immediately after the intervention.]

Критерии участия

Критерии включения

  • Aged 60-85 years;
  • With non-specific chronic low back pain that has no definitive diagnosis but lasted for at least 3 months, typically occurs in the area between the lower rib margins and the buttock creases;
  • With an average pain intensity over the last week to be ≥ 3 on an 11-point numerical rating scale (NRS) anchored with "no pain" at zero and "worst pain imaginable" at 10;
  • Have normal cognitive function (Hong Kong Montreal Cognitive Assessment ≥ 22);
  • Who agree to sign an informed consent form.

Критерии исключения

  • Inability to ambulate without assistance from another person or tools (e.g., canes or walkers);
  • Having specific causes of low back pain (e.g., spinal stenosis, lumbar disc herniation, spondylolisthesis, recent vertebral fracture, spinal infection);
  • Having other acute or overt musculoskeletal conditions in other parts of the body (e.g., fractures, severe pain, multiple joint pain (e.g., knee pain));
  • History of lumbar or lower extremity surgery;
  • Receiving LBP treatment within the past one month or at present;
  • Have never received non-invasive brain stimulation (e.g., transcranial direct current stimulation, repetitive transcranial magnetic stimulation, and transcranial alternating current stimulation) before.

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

Китай · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06706479 · HSEARS20240416001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗