Pulsed Direct Current Electrical Stimulation for Treatment of Low Back Pain

Официальное название

Efficacy of Pulsed Direct Current Electrical Stimulation (Neubie) on Low Back Pain

Обзор

The goal of this interventional clinical trail is to determine the efficacy of the use of the Neubie pulsed direct current electrical stimulation device for the treatment of participants experiencing mechanical low back pain. The main question it aims to answer is: Does treatment with the Neubie improve symptoms and time to resolution of back pain compared to standard of care? Researchers will compare a 12 session treatment physical therapy regimen using the Neubie to standard of care to see if there is a difference in symptom severity and time to resolution. Participants will: * Visit the clinic 2 times a week to undergo active physical therapy treatments with or without electrical stimulation from the Neubie. * Undergo testing and fill out surveys on evaluation and final session on quality of life, disability, pain, and spinal mobility.

Подробное описание

To determine the efficacy of direct current (DC) electrical stimulation (the Neubie device) on back pain, patients presenting with mechanical, non-radicular low back pain will enroll in a 4 to 6 week treatment regimen at EA Therapeutic Health. The first session will consist of an intake evaluation session that will include: Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index. These tests will serve as baseline (and a within subject control) for the intervention.

Participants will then undergo a treatment protocol that incorporates either traditional physical therapy (PT) exercises (standard of care control) or PT exercises with the Neubie utilized concurrently (experimental group). Subjects will undergo an evaluation session prior to starting treatment that includes the Modified Oswestry Pain Scale, The Schober test for mobility, Heart Rate Variability, and Quality of Life Index.

The experimental group subjects will undergo 12 sessions of physical therapy over a 4 to 6-week period which include 45 min of various physical therapy exercises concurrently with the Neubie followed by a 15 minute passive Vagus nerve stimulation protocol with the Neubie.

Control group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the sacroiliac (SI) joint and exercises for back strengthening and stretching. Experimental group subjects will participate in a physical therapy protocol that includes manual therapy (e.g. trigger point release, mobilization of the SI joint) and exercises for back strengthening and stretching in conjunction with Neubie DC e-stim. Both control and experimental groups will receive a customized Home Exercise Program with exercises to be performed at home 1 time a day.

Вмешательства

• Устройство Neubie Direct Current Stimulation Device
  Pulsed Direct Current Electrical Stimulation Device

Первичные конечные точки

• Modified Oswestry Disability Index [Срок оценки: Pre-intervention]
• Modified Oswestry Disability Index [Срок оценки: 6 weeks]
• Visual Analog Pain Scale [Срок оценки: Pre-intervention]
• Visual Analog Pain Scale [Срок оценки: 6 weeks]
• Schober Test [Срок оценки: Pre-intervention]
• Schober Test [Срок оценки: 6 weeks]
• Quality of Life Index [Срок оценки: Pre-intervention]
• Quality of Life Index [Срок оценки: 6 weeks]
• Heart Math HRV [Срок оценки: Pre-intervention]
• Heart Math HRV [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Must show evidence of axial mechanical low back pain at least 3/10 on visual analog scale, without radiation to the lower limbs. Pain has to have been present for at least two weeks or diagnosed as chronic .
• Normal lower limb strength
• Able to attend twice weekly physical therapy visis for up to 6 weeks
• 18 years of age, or older

Критерии исключения

• Currently pregnant
• Cardiac pacemaker
• Active or recently treated cancer
• Active or recent blood clots
• Epilepsy
• Open wounds
• History of lumbar spine fusion surgery
• Radicular symptoms suggesting radiculopathy or spinal stenosis.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06984224 · Pro00086182

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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