The Effect of Perception of Improvement in Patients With Fibromyalgia
NCT Number: NCT06508385
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia
Interventions: OTHER: Breathing exercise
Sponsor: Istanbul Medeniyet University
Sex: FEMALE
Age: ADULT
Enrollment: 39
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-15

Summary:
Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.

Primary Outcome Measures: Functional Magnetic Resonance, The process of processing pain will be determined by functional magnetic resonance imaging performed immediately before and after the experimental pressure pain., changes from baseline process of processing pain will be measured at 6 week and 10 week|Measurement of Pain Intensity, Pain will be evaluated by McGill-Melzack Pain Scale., changes from baseline of pain will be measured at 6 week and 10 week|Measurement of pain-pressure threshold, Pain-pressure threshold evaluated with a pain threshold measuring device with functional MRI. The device was specially developed for the study., changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week
Secondary Outcome Measures: Measurement of biomechanical and viscoelastic characteristics of tissue, Biomechanical and viscoelastic characteristics of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

Biomechanical and viscoelastic characteristics of tissue will be measured with myotonPro B1 over the contralateral of the points reported as the three most painful points in Virtual Reality-2 Group., changes from baseline of biomechanical and viscoelastic characteristics of tissue will be measured at 6 week and 10 week]|Sleep Quality, Sleep quality will be evaluated with Pittsburgh Sleep Quality Index, changes from baseline of sleep quality will be measured at 6 week and 10 week|Functional status and disease impact, Functional status and disease impact will be evaluated with Revised Fibromyalgia Impact Questionnaire, changes from baseline of functional status and disease impact will be measured at 6 week and 10 week|Quality of Life of patients, Quality of Life will be measured with QOL Short Form 12, changes from baseline of quality of life will be measured at 6 week and 10 week|Anxiety and Depression Status, Anxiety and Depression will be evaluated with Hospital Anxiety and Depression Scale, changes from baseline of anxiety and depression status will be measured at 6 week and 10 week|Pain catastrophizing behavior, Assessing pain catastrophizing behavior will be evaluated with Pain Catastrophizing Scale, changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week|Patient satisfaction, Patient satisfaction will be evaluated with Global Rating of Change, changes from baseline of patient satisfaction will be measured at 6 week and 10 week