Comparison of the Effects of Pain Neuroscience Education and Vagus Nerve Stimulation on Recovery in Individuals With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain Catastrophizing Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients who are taken into one of the three intervention groups will not have any idea or information about the interventions being performed in other groups.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Catastrophizing Scale
时间窗: 8 weeks
13-item questionnaire, based on personal feedback, assesses the severity of patients' reactions to pain on a scale of 0-4. The validity and reliability of the questionnaire in Turkish has been established.
Disease Activity Score-28 (DAS28)
时间窗: 8 weeks
Assesses disease activity in 28 different joints. Blood draws will be performed by a specialist physician who diagnoses patients, conducts regular checkups, and then refers suitable patients to a physical therapist. A score below 2.6 indicates the disease is in remission; scores between 2.6 and 3.1 indicate low disease activity; scores between 3.1 and 5.1 indicate moderate disease activity; and scores above 5.1 indicate high disease activity.
次要结局
- Demographic Information Form(At the beginning only)
- Mcgill Pain Questionnaire Short Form(8 weeks)
- Pain Algometry(8 weeks)
- Pain Coping Inventory(8 weeks)
- Tampa Kinesiophobia Scale(8 weeks)
- Bristol Rheumatoid Arthritis Multidimensional Fatigue Questionnaire(8 weeks)
- Pittsburgh Sleep Quality Scale(8 weeks)
- Rheumatoid Arthritis Quality of Life Scale(8 weeks)
- Upper and Lower Extremity Goniometry and Circumference Measurements(8 weeks)
- Multiple Choice Questions and Answers(8 weeks)
研究者
Simay Akdemir
MSc. Phd Candidate, Lecturer Physical Therapist
Medipol University