Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07274124

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cerrahpaşa Faculty of Medicine Hospital

Istanbul, Fatih, Turkey (Türkiye)

Location contact

Serdal UĞURLU, Prof. Dr.

CONTACT

[email protected]

+905424356265

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pain neuroscience education

Other

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 videos, pictures and drawings. Intervention will last for 8 weeks, 2 times per week, in total 16 sessions will be completed. Each session will last 30 minutes in average and at the same time, patients will be advised to perform the given home exercises for 2 times per week. Assessments will be performed before and after the intervention.

Vagal Nerve Stimulation

Other

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 the literature has missing knowledge about the effects of Vagal nerve stimulation in rheumatoid arthritis, the results will highlight the effects on pain and inflammatory markers in this population. Current will be given from the left ear/transauricular area to prevent the side effects in the sessions.

Structured Exercises

Other

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 setting. An exercise diary will be asked from patients to control if they continue to their exercises regularly for 2 times for 8 weeks.

Primary outcomes

  1. Pain Catastrophizing Scale

    Time frame: 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.

  2. Disease Activity Score-28 (DAS28)

    Time frame: 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.

Secondary outcomes

  1. Demographic Information Form

    Time frame: At the beginning only

    The patient's personal information, medical treatment history, current lifestyle, and exercise habits will be inquired about using a form specifically designed for the specific disease.

  2. Mcgill Pain Questionnaire Short Form

    Time frame: 8 weeks

    Developed by Melzack in 1987, the questionnaire assesses chronic pain in three sections: pain characteristics, severity, and intensity, has also been validated in Turkish and is recommended for use in rheumatological patients. The Turkish validation of the questionnaire was conducted by Yavuz et al. in 2007, and it was found to be valid in Turkish. Higher score indicates severe pain severity.

  3. Pain Algometry

    Time frame: 8 weeks

    The pressure pain threshold (PPT), defined as the minimum pressure stimulus applied to elicit pain, is suitable for measuring pain in RA. Pain thresholds will be measured using an algometer at the third metacarpophalangeal (MCP) joints, the wrist, and the most inflamed joints.

  4. Pain Coping Inventory

    Time frame: 8 weeks

    Indicates how frequently patients use behavioral and cognitive methods to cope with pain. The questionnaire, consisting of 6 subscales (active and passive), inquires about patients' orientations during painful situations. Items are scored on a 4-point Likert scale, with 1 being the least frequent use of pain management measures and 4 being the most frequent.

  5. Tampa Kinesiophobia Scale

    Time frame: 8 weeks

    Published in 1995 to measure fear of movement and re-injury, the questionnaire consists of 17 items. Questions address areas such as fear of re-injury and avoidance of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible.

  6. Bristol Rheumatoid Arthritis Multidimensional Fatigue Questionnaire

    Time frame: 8 weeks

    Examines the various dimensions of the effects of RA on fatigue. It was developed in 2010. The questionnaire consists of four subcategories: physical fatigue in the last 7 days, fatigue in activities of daily living, and cognitive and emotional fatigue. Patients receive scores between 0 and 70 on the 20-question questionnaire, with higher scores indicating higher fatigue.

  7. Pittsburgh Sleep Quality Scale

    Time frame: 8 weeks

    19-item scale questions subjective sleep quality over the past month. The total score ranges from 0 to 21, with a higher score indicating poor sleep quality. A Turkish version of the scale is available and is used in rheumatological diseases.

  8. Rheumatoid Arthritis Quality of Life Scale

    Time frame: 8 weeks

    30-item scale, with valid and reliable Turkish versions, is a published quality of life questionnaire specific to rheumatoid arthritis. Higher scores indicate lower quality of life.

  9. Upper and Lower Extremity Goniometry and Circumference Measurements

    Time frame: 8 weeks

    To examine the relationship between pain and joint range of motion, goniometry measurements will be taken at the four most commonly affected areas: the atlantoaxial joint, shoulder joint, wrist joint, and ankle with the degree of movement.

    Circumference measurements will be taken at the hand, finger, and ankle to assess inflammation in the centimeter measures.

  10. Multiple Choice Questions and Answers

    Time frame: 8 weeks

    Participants in the PNE group will be asked to answer 10 multiple-choice questions covering the presentation topics. This will provide information about the level of understanding of the information presented within the PNE group and its impact on the pain questionnaires, according to the score they take out of the total score of 100.

Study contacts

Contact information is provided by the study sponsor or research team.

Ela TARAKCI, Prof. Dr.

CONTACT

[email protected]

+905422175730

Simay AKDEMİR, MSc. Phd Candidate/Lec.

CONTACT

[email protected]

+905347032126

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.