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Набор скоро начнётся NCT07313826

Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy

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: Active Neurolumen, Inactive Neurolumen.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain. Базовые параметры: 18 лет — 70 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
США
Следующий шаг
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Официальное название

Neurolumen for Chronic Lower Back Pain: A Pilot RCT Study

Обзор

This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.

Подробное описание

Chronic low back pain is debilitating and difficult to treat. The commercially-available Neurolumen medical device uses a combination of electrical stimulation, low-level laser, and LED therapies to treat pain. Separately, each of these treatments has shown promise for treating chronic pain. In a recent survey by the manufacturer involving over 4700 Veterans who were prescribed a Neurolumen device through their local VA facility, 93% of patients reported a reduction in pain levels, and 52% report reduction in medication, including 6% who reported cessation of all medication. Additionally, average pain levels of 7.01/10 dropped to 3.38/10 after 6 weeks of use (unpublished data). Thus, there is theoretical support and preliminary evidence for the utility of Neurolumen for treating chronic pain; yet, it is unknown whether these findings generalize to other populations. Furthermore, while a reduction in retrospective pain and medication use are promising, prospectively-collected clinical outcomes of Neurolumen use have yet to be examined. This study will examine the feasibility and efficacy of the Neurolumen devices for treating chronic lower back pain using a double-blind pilot randomized controlled trial design with a placebo/waitlist control.

Вмешательства

  • Устройство Active Neurolumen
    Neurolumen has been cleared by the FDA for the treatment of pain (FDA: 142025) and utilizes a combination of low-level lasers, Light-Emitting Diodes, and electrical stimulation over a 30-minute treatment period to target inflammation and circulation to the affected area. Participants will use the device daily for 4 weeks.
  • Устройство Inactive Neurolumen
    The sham Neurolumen device will look the same an the Active Neurolumen, and will appear to turn on, but will not provide any treatment

Первичные конечные точки

  • Pain Intensity [Срок оценки: Weeks 1-12]
  • Pain Medication Use [Срок оценки: Weeks 1-12]
Вторичные конечные точки (2)
  • Physical Function [Срок оценки: Weeks 1-12]
  • Sleep Disturbance [Срок оценки: Weeks 1-12]

Критерии участия

Критерии включения

  • Diagnosed with LBP with an average pain score of 4 or higher on DVPRS for > 3 months
  • Ability to sit or lay down for 30 minutes during treatments
  • Demonstrated ability to correctly use the device and maintain adequate sensor contact throughout (assisted or unassisted)
  • Female participants who could possibly become pregnant must agree to use a highly effective contraceptive method from the screening period through the 4 weeks of study intervention and any use during the wait-list control period. These methods include a physical barrier method (e.g., condom) plus an additional hormonal, IUD, tubal ligation, or second type of barrier (e.g., diaphragm). In addition, they must abstain from egg collection or donation during the same period.

Критерии исключения

  • Individuals < 18 or >70 years of age at enrollment
  • Persons with Pacemakers, or interstitial pumps, or spinal cord stimulator in ON mode.
  • Persons who have received back surgery (open) within the last 3 months
  • Pregnant or sexually active female subjects who could possibly become pregnant and who are not willing to use an acceptable form of contraception (barrier method plus one of the following: second barrier, hormonal, IUD, or tubal ligation).

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Naval Medical Center Portsmouth — Portsmouth

Идентификаторы

NCT: NCT07313826 · USUHS.2025-167

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗