Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

Обзор

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

Вмешательства

• Устройство tSpinalStim
  Patients will undergo 12-21 sessions of spinal cord stimulation therapy (30 minutes per session, 3 times a week). Up to five round stimulating electrodes will be placed on the skin midline between spinous processes in cervical, thoracic and/or lumbar region, as cathodes and rectangular pads will be placed symmetrically on the skin over the iliac crests as anodes. The stimulator generates pain-free biphasic rectangular waveform with 1 ms width pulses filled with 5-10 kHz (kilohertz) carrier frequ

Первичные конечные точки

• Visual Analogue Scale (VAS) score [Срок оценки: 3 hours]
• Max Sagittal Vertical Axis [Срок оценки: 3 hours]
• L5S1/Torso Max Flex/Ext angle [Срок оценки: 3 hours]
• L5S1/Torso Max velocity [Срок оценки: 3 hours]
• Hip/Pelvis Max Flex/Ext angle [Срок оценки: 3 hours]
• Hip/Pelvis Max velocity [Срок оценки: 3 hours]
• Thing/Knee Max Flex/Ext angle [Срок оценки: 3 hours]
• Thing/Knee Max Velocity [Срок оценки: 3 hours]
• Insula - Cingulate connectivity [Срок оценки: 3 hours]
• Default Mode Network connectivity [Срок оценки: 3 hours]

Вторичные конечные точки (3)

• Shank/Ankle Max Flex/Ext angle [Срок оценки: 3 hours]
• Shank/Ankle Max velocity [Срок оценки: 3 hours]
• Erector Spinae activation (Root Mean Square) [Срок оценки: 3 hours]

Критерии участия

Критерии включения

• Low back pain
• Able to get in and out of chair unassisted
• No changes in medication within 2 weeks of study enrollment
• Stable dose of their medications within 2 weeks of study enrollment

Критерии исключения

• Body Mass Index (BMI) > 28
• Hardware in the spine from prior surgeries
• Presence of epidural stimulation leads
• Presence of any additional neuromuscular pain unrelated to spinal condition
• Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past
• Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours
• Changes in medications within 2 weeks of study enrollment
• Moderate/severe depression (Beck Depression Inventory score > 20)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• San Francisco VA Medical Center — San Francisco

Идентификаторы

NCT: NCT05265000 · tSCS4LBP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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