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

ConditionsRheumatic DiseasesRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorMedipol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who were diagnosed with RA at least one year ago,

More than score 2.6 in DAS28,

Ages of 20 and 65,

Have been experiencing pain for three months or more,

Disqualifiers

Individuals under 20 years of age,

Reporting acute pain or pain from injury,

Having a history of surgery within the last year,

Remission in DAS28,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pain Neuroscience Education

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: Pain Neuroscience Education + Structured ExerciseExperimental treatment 2 interventions
Group B: Vagal Nerve Stimulation + Structured ExerciseExperimental treatment 2 interventions
Group C: Structured ExerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Catastrophizing Scale

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.

Time frame
8 weeks
2

Disease Activity Score-28 (DAS28)

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.

Time frame
8 weeks

Secondary outcomes

1

Demographic Information Form

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.

Time frame
At the beginning only
2

Mcgill Pain Questionnaire Short Form

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.

Time frame
8 weeks
3

Pain Algometry

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.

Time frame
8 weeks
4

Pain Coping Inventory

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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Medipol University

Lead sponsor

Istanbul University - Cerrahpasa

Collaborator

Source ClinicalTrials.gov
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