Pain Neuroscience Education and Vagus Nerve Stimulation on Recovery in Individuals With Rheumatoid Arthritis

Официальное название

Comparison of the Effects of Pain Neuroscience Education and Vagus Nerve Stimulation on Recovery in Individuals With Rheumatoid Arthritis

Обзор

In the context of this randomized controlled study, patients who are diagnosed with Rheumatoid arthritis in Cerrahpaşa Faculty of Medicine Hospital, will be taken into a rehabilitation program by a qualified physiotherapist to improve their pain, pain perception, inflammatory markers and quality of life, with one of the pain neuroscience education, vagal nerve stimulation and traditional exercise interventions. The results of each intervention method will be analyzed and compared at the end of the 8 weeks study protocol.

Подробное описание

Pain, a complex and multifaceted experience, is the most common symptom observed in inflammatory arthritis. In addition to pathological events such as inflammation and tissue infection, various personal, social, and behavioral factors such as illness beliefs, mood, behavior, avoidance, sleep disturbance, and daily rest and activity status also contribute to pain and pain perception. According to the 2018 EULAR recommendations, the principles of pain management methods are based on a patient-centered care and social assistance models of rehabilitation. According to PNE, the primary cause of chronic pain is not an organ or tissue damage, but rather over activation of the central nervous system and central sensitization and the goal is to reduce CNS activation, minimize fear of movement, and increase pain tolerance, thereby supporting exercise participation. Based on the biopsychosocial model, this method aims to reduce movement and illness avoidance behavior by reshaping pain perception. It is typically presented to patients through one-on-one or group meetings, phone calls, or visual brochures. Another effective method on the indicated pain related symptoms is known as Vagal nerve stimulation. Neural regulation can be achieved by vagal nerve stimulation, which is related to the pain-processing pathways of the brain, or pain reduction can be achieved indirectly through the anti-inflammatory effect it creates. While studies in the literature on VNS mostly focus on individuals with chronic pain, fibromyalgia, abdominal pain, and headache, there are few studies on rheumatoid arthritis. Besides no studies have examined the effects of PNE. This research points to a significant deficiency in pain perception, awareness, and control in individuals with RA. Based on this information, the aim of this study was to examine the effects of pain neuroscience training and vagal nerve stimulation on healing parameters in individuals with rheumatoid arthritis and to compare the results in terms of their superiority.

Вмешательства

• Другое Pain Neuroscience Education
  Many sources in the literature draw attention to patient education as the first stage of treatment and the most common educational technique that focuses on the perception, mechanism and modulation of pain is known as Pain Neuroscience Education (PNE). Patients in this group will take educational sessions about the pain, facilitators of pain, the factors affecting the pain perception and how to deal with chronic pain in rheumatoid arthritis with the help of power point presentations, animation v
• Другое Vagal Nerve Stimulation
  Vagus nerve (cranial nerve X) is the longest and most widely distributed cranial nerve containing sensory, motor, and parasympathetic fibers. It plays an important role in the regulation of cardiovascular, respiratory, immune, endocrine, and autonomic systems, as well as homeostasis. Participants with rheumatoid arthritis will be taken into stimulation sessions for 2 times per week for continuous 8 weeks. Assessments will be performed before study and after the 16 sessions are completed. Since t
• Другое Structured Exercises
  Structured exercise planned in this study is based on the principles and suggestions of EULAR, by consisting warm-up, basic exercise and warm up sessions by combining different exercise types like aerobic, strengthening flexibility, breathing and definitely by including hand specific exercises. Participants in all three groups will be educated in the first session about the exercises to prevent wrong application and injuries. Afterwards, all groups will continue to their exercises at the home se

Первичные конечные точки

• Pain Catastrophizing Scale [Срок оценки: 8 weeks]
• Disease Activity Score-28 (DAS28) [Срок оценки: 8 weeks]

Вторичные конечные точки (10)

• Demographic Information Form [Срок оценки: At the beginning only]
• Mcgill Pain Questionnaire Short Form [Срок оценки: 8 weeks]
• Pain Algometry [Срок оценки: 8 weeks]
• Pain Coping Inventory [Срок оценки: 8 weeks]
• Tampa Kinesiophobia Scale [Срок оценки: 8 weeks]
• Bristol Rheumatoid Arthritis Multidimensional Fatigue Questionnaire [Срок оценки: 8 weeks]
• Pittsburgh Sleep Quality Scale [Срок оценки: 8 weeks]
• Rheumatoid Arthritis Quality of Life Scale [Срок оценки: 8 weeks]
• Upper and Lower Extremity Goniometry and Circumference Measurements [Срок оценки: 8 weeks]
• Multiple Choice Questions and Answers [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Individuals who were diagnosed with RA at least one year ago,
• Ages of 18 and 65,
• Have been experiencing pain for three months or more,
• Score 24 or higher on the Mini Mental State Examination (MMSE), and can follow instructions will be included in the study.

Критерии исключения

• Individuals under 18 years of age,
• Reporting acute pain or pain from injury,
• Having a history of surgery within the last year,
• Having a score of <24 on the MMSE,
• Having any of the cerebrovascular disease, cardiovascular disease, symptomatic coronary artery disease, myocardial infarction, congestive heart failure, or uncontrolled hyper/hypotension,
• History of vagotomy surgery, or having an implanted electrical/neurostimulator device will not be included in the study.

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

Turkey (Türkiye) · 1 центр

• Cerrahpaşa Faculty of Medicine Hospital — Istanbul

Идентификаторы

NCT: NCT07274124 · E-10840098-202.3.02-7253

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗