Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch

Официальное название

Neck Traction to Reduce Gabaergic Medication Use for Neuropathic Itch- A Pilot Study

Обзор

The purpose of this study is to determine if cervical traction is an effective treatment to reduce GABAergic medication use for scalp, arm, and upper back neuropathic itch.

Вмешательства

• Устройство Cervical Traction Device
  Participants will use their home neck traction devices daily for 12 weeks, while continuing their prescriptions for gabapentin or pregabalin. At study initiation and every 2 weeks thereafter for a total of 12 weeks, they will receive an electronic survey assessing their itch score. Based on survey results, they will receive a call from the study team to adjust their dosage of gabapentin or pregabalin by up to 33%.

Первичные конечные точки

• Change in GABAergic medication usage [Срок оценки: Baseline, 12 weeks]

Вторичные конечные точки (1)

• Pruritus Severity Score [Срок оценки: Baseline, 14 days, 28 days, 42 days, 56 days, and 72 days]

Критерии участия

Критерии включения

• Persons with scalp, arm, and upper back pruritus without primary skin lesions.
• Persons 18 or older.
• Person on a stable dosage of gabapentin or pregabalin over the preceding 4 week period.
• Persons willing and able to comply with clinic visits and study-related procedures.
• Persons willing and able to understand and complete study-related questionnaires.
• Persons willing and able to provide voluntary signed informed consent.

Критерии исключения

• Primary skin lesions driving scalp, arm, or upper back pruritus.
• A history of spinal surgery or other conditions (acute or traumatic spinal injury, spinal instability, spinal fracture, rheumatoid arthritis, metastatic disease to the spine, spinal cord compression, active infections of the head and neck) that would make neck traction contraindicated.
• Unable to comfortably lay down on the floor and get back up without assistance.
• Medical conditions in which gabapentin and/or pregabalin is contraindicated.
• Current enrollment in physical therapy with exercises addressing the cervical spine.
• Planned or anticipated use of any prohibited medications or procedures during study treatment.
• Presence of skin comorbidities that may interfere with study assessments.
• Currently pregnant or breastfeeding or plans to become pregnant or breastfeed during the participation in the study. Persons of childbearing age who are not on reliable contraception will be considered on a case-by-case basis.

o Participants of childbearing age who are not on reliable contraception (hormonal contraceptive pills, patch, or ring, intrauterine device, subdermal hormonal implant, tubal ligation, depot medroxyprogesterone injections) will be required to complete monthly urine pregnancy tests.

• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to, a short life expectancy, persons with uncontrolled diabetes (HbA1c ≥ 9%), cardiovascular conditions (e.g. stage III or IV cardiac failure), severe renal conditions (e.g. patients on dialysis), debilitating neurological conditions (e.g. demyelinating diseases), active major autoimmune diseases (e.g. lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), or other severe endocrinological, gastrointestinal, hepatobiliary, metabolic, pulmonary, or lymphatic diseases. The specific justification for persons excluded under this criterion will be noted in study documents.
• Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make participation unreliable, or may interfere with study assessments. The specific justification for persons excluded under this criterion will be noted in study documents.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Arizona — Scottsdale

Идентификаторы

NCT: NCT06751056 · 24-003108

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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