Assessment and Rehabilitation in Cervical Radiculopathy

Официальное название

Patient With Cervical Radiculopathy - Complete Assessment and Rehabilitation

Обзор

The investigators perform a prospective controlled study and analyse the effects of a rehabilitation program, including oral anti-inflammatory drugs, nutraceutical - ProHumano+ SpineDinamic (PHSD), physical therapy and kinetic measures on reduction of the severity of radicular pain, and improvement of the quality of life in participants with cervical radiculopathy (CR) over a relatively short period of treatment (three months). The major tasks in the assessment and management of CR are to exclude signs and/or symptoms of possible serious underlying pathology, to focus on an active approach to promote the natural recovery and to prevent chronicity through early tailored rehabilitation

Вмешательства

• Комбинированный продукт All patients in the study will be included in rehabilitation program
  A total of 110 consecutive participants with previous diagnosed CR lasting more than 3 months will be enrolled in this study. After initial assessment, participants without surgical recommendation, will be included into two groups: Study Group will be received 10 sessions of rehabilitation program and nutraceutical product daily, 3 months, and Control Group will be received 10 sessions of rehabilitation program. The rehabilitation program include physical therapy (electrical muscle stimulation o
• Пищевая добавка Study Group will receive a nutraceutical product daily, 3 months.
  Study Group will receive a nutraceutical product daily, 3 months in addition to the rehabilitation program.

Первичные конечные точки

• Neck Disability Index [Срок оценки: 3 months]
• Visual Analogue Scale For Pain [Срок оценки: 3 months]

Вторичные конечные точки (1)

• Improving quality of life- Katz Index of Independence in Activities of Daily Living [Срок оценки: 3 months]

Критерии участия

Критерии включения

• patients older than 50 years of age;
• lasting more than 3 months and diagnosed with CR confirmed by MRI in the last 6 months;
• absence of other significant and disability upper limb osteoarthritis;
• patients with stable cardiovascular and respiratory function, without unstable medical conditions;
• compliance with physical exercise during the healthcare program.

Критерии исключения

• pregnancy or breastfeeding;
• need for surgical treatment;
• intolerance to any component of the nutraceutical product;
• malignancy;
• modified laboratory test (ALT, AST, or Urea >2x% reference range, Creatinine >3x% reference range).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Румыния · 1 центр

• Diana Kamal — Craiova

Идентификаторы

NCT: NCT07054450 · FilantropiaH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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