Clinical trial NCT06508385: The Effect of Perception of Improvement in Patients With Fibromyalgia
Official title: The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: functional brain activity
Pain
Tissue properties
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 39
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria

Age range 25-55

Female

Scored at least 24 on the Mini-Mental State Assessment Test

Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale

Be on a stable dose of medication for at least 6 months (serotonin norepinephrine reuptake inhibitors \[e.g., duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[e.g., pregabalin\]; gabapentinoids)

Exclusion Criteria:

Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, uncontrolled endocrine diseases

Body Mass Index (BMI) ≥ 30 Kg/m2

Being pregnant

Having inability to understand, read and speak Turkish

Having difficulty in hearing and seeing

Having any metallic or electronic device in the body that will create incompatibility with the magnetic field in the fMRI scan Having any disease diagnosis (serious psychotic disorder, delirium, mental retardation, epilepsy, heart disease, lung diseases, etc.) that may prevent participation in the evaluation and training to be conducted within the scope of the research

Primary outcomes:
measure: Functional Magnetic Resonance
timeFrame: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week
measure: Measurement of pain-pressure threshold
timeFrame: Measurement of changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week
Secondary outcomes:
measure: Sleep Quality
timeFrame: Measurement of changes from baseline of sleep quality will be measured at 6 week and 10 week
measure: Functional status and disease impact
timeFrame: Measurement of changes from baseline of functional status and disease impact will be measured at 6 week and 10 week.
measure: Quality of Life of patients
timeFrame: Measurement of changes from baseline of quality of life will be measured at 6 week and 10 week
measure: Anxiety and Depression Status
timeFrame: Measurement of changes from baseline of anxiety and depression status will be measured at 6 week and 10 week
measure: Pain catastrophizing behavior
timeFrame: Measurement of changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week
measure: Patient satisfaction
timeFrame: Measurement of changes from baseline of patient satisfaction will be measured at 6 week and 10 week
measure: Measurement of biomechanical characteristics of tissue
timeFrame: Measurement of changes from baseline stiffness values of tissue will be measured at 6 week and 10 week]
measure: Measurement of biomechanical characteristics of tissue
timeFrame: Measurement of changes from baseline tone values of tissue will be measured at 6 week and 10 week]
measure: Measurement of biomechanical characteristics of tissue
timeFrame: Measurement of changes from baseline decrement values of tissue will be measured at 6 week and 10 week]
measure: Measurement of viscoelastic characteristics of tissue
timeFrame: Measurement of changes from baseline creep values of tissue will be measured at 6 week and 10 week]
measure: Measurement of viscoelastic characteristics of tissue
timeFrame: Measurement of changes from baseline relaxation time values of tissue will be measured at 6 week and 10 week]
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nilüfer kablan
state: Kartal
Study officials:
affiliation: İstanbul Medeniyet Üniversitesi
name: Nilüfer Kablan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
citation: Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
citation: Caneiro JP, Bunzli S, O'Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Braz J Phys Ther. 2021 Jan-Feb;25(1):17-29. doi: 10.1016/j.bjpt.2020.06.003. Epub 2020 Jun 20.
citation: Ciaramella A. Hypnotic analgesia in chronic pain: role of psychopathology and alexithymia. Am J Clin Hypn. 2023 Apr;65(4):299-313. doi: 10.1080/00029157.2022.2161868. Epub 2023 Feb 7.
citation: de la Coba P, Montoro CI, Reyes Del Paso GA, Galvez-Sanchez CM. Algometry for the assessment of central sensitisation to pain in fibromyalgia patients: a systematic review. Ann Med. 2022 Dec;54(1):1403-1422. doi: 10.1080/07853890.2022.2075560.
citation: Gholamrezaei A, Van Diest I, Aziz Q, Vlaeyen JWS, Van Oudenhove L. Controlled breathing and pain: Respiratory rate and inspiratory loading modulate cardiovascular autonomic responses, but not pain. Psychophysiology. 2021 Oct;58(10):e13895. doi: 10.1111/psyp.13895. Epub 2021 Jul 6.
citation: Ichesco E, Puiu T, Hampson JP, Kairys AE, Clauw DJ, Harte SE, Peltier SJ, Harris RE, Schmidt-Wilcke T. Altered fMRI resting-state connectivity in individuals with fibromyalgia on acute pain stimulation. Eur J Pain. 2016 Aug;20(7):1079-89. doi: 10.1002/ejp.832. Epub 2016 Jan 15.