Идёт набор NCT06825390

AuriculoTherapy NeuroImaging

Без фазы С лечением Low Back Pain Chronic Low-back Pain Back Pain, Low Lumbar Disc Disease

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: Cryo-auriculotherapy, Sham auriculotherapy, Experimental auricular stimulation.
Кому может быть актуально: Состояния в реестре: Low Back Pain, Chronic Low-back Pain, Back Pain, Low, Lumbar Disc Disease. Базовые параметры: от 18 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Mechanistic Clinical Trial of Auricular Stimulation and Cryogenic Auriculotherapy in Patients With Chronic Low-back Pain, Using Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging

Обзор

This is a clinical study of patients who have low back pain (for at least 6 months). The goal is to understand, with brain imaging, how auriculotherapy (an acupuncture-like stimulation of the ear) may work to relieve pain. There are 4 total study visits, divided into two pairs of visits that occur before and 5-7 days after receiving either a real or sham auriculotherapy treatment. The cryo-IQ device will be used, to stimulate 7 small areas on both ears with a focused jet of cold as a small amount of compressed gas is released. This is generally not painful, and less invasive, compared to using needles for auriculotherapy.

Подробное описание

This is a 1:1 randomized, double-blind, sham-controlled, within-subject crossover trial of cyro-auriculotherapy in patients with chronic low back pain. Cryo-auriculotherapy is an effective alternative to needles, in which compressed gas provides focal (\~1 mm2) persistent stim of auricular points, with minimal pain. Both before and 5-7 days after (time of peak effect) active vs. sham cryo-AT, resting brain connectivity will be measured with functional MRI and responses to a non-therapeutic experimental auricular stim paradigm (using von Frey filaments) will be recorded with functional near infra-red spectroscopy. After a 2-month washout period, patients will return for the same data collection surrounding the crossover intervention.

Вмешательства

Устройство Cryo-auriculotherapy
The cryo-IQ device (containing compressed nitrous oxide) with a narrow-tip nozzle will be used. After disinfection of the device and both ears, 7 inter-related points in the auricular cartography will be treated with a 1-2 second application of cold gas, applied to both ears. Treatment points will be: mesoderm master, spine, reticular formation, sensory master point, thalamus, adrenocorticotropic hormone, and corpus callosum.
Устройство Sham auriculotherapy
For the sham procedure, an empty gas canister will be used in the cryo-IQ device. This will make the same noise and temporary skin imprint on the ear, but does not deliver any cooling effect. The same 7 ear points will be sham-treated in a protocol that is imperceptibly different from the verum auriculotherapy treatment.
Другое Experimental auricular stimulation
Three points on each ear will be repeatedly stimulated with a plastic (von Frey) filament. This will be felt, but not be painful and should not result in lasting irritation.

Первичные конечные точки

functional near-infrared spectroscopy response, Lumbar spine vs. thumb auricular points [Срок оценки: Baseline visit, over 10 minutes of data collection]
Change in fNIRS response for Lumbar auricular point, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation [Срок оценки: Baseline, 5-7 days; 2 months, 9 weeks]
Change in functional connectivity, for post- vs. pre- verum auriculotherapy, compared to post- vs. pre- sham auricular stimulation [Срок оценки: Baseline, 5-7 days; 2 months, 9 weeks]

Критерии участия

Критерии включения

Adult, at least 18 years old
Episodes of chronic low back pain at least daily for at least 6 months, with an average pain score within the last week of 3/10.

Критерии исключения

active lesions, skin disruptions, or neuropathy of either ear;
recent (<1 month) analgesic procedures or surgery;
recent (<1 month) start of new analgesic or psychoactive medication (including marijuana, opioids, tramadol, methadone, gabapentinoids, anti-depressants, anti-epileptics, mood-stabilizers, anti-psychotics, or stimulants);
history of chronic pain in shoulder or thumb (to avoid confounding at control stimulation points);
recent (< 3 months) illicit drug use;
prior substance misuse/abuse;
cold-activated diseases (including: agammaglobulinemia, cold urticaria, cold agglutinin disease, cryofibrinogenemia, cryoglobulinemia, immunosuppression, Raynaud's disease, collagen or autoimmune diseases, multiple myeloma, platelet deficiency disorders, pyoderma gangrenosum.)

\- MRI-specific exclusions additionally include: