The Effect of Perception of Improvement in Patients With Fibromyalgia

NCT06508385 | Recruiting

• 1 other identifier: 2023/0689
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

functional brain activity; Pain; Tissue properties

Outcome Measures

Primary Outcomes (2)

• 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. ROI analysis will ve performed. No score is defined.

  Measurement of changes from baseline process of processing 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 (Algometer).

  Measurement of changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week

Secondary Outcomes (11)

• Sleep Quality

  Measurement of changes from baseline of sleep quality will be measured at 6 week and 10 week

• Functional status and disease impact

  Measurement of changes from baseline of functional status and disease impact will be measured at 6 week and 10 week.

• Quality of Life of patients

  Measurement of changes from baseline of quality of life will be measured at 6 week and 10 week

• Anxiety and Depression Status

  Measurement of changes from baseline of anxiety and depression status will be measured at 6 week and 10 week

• Pain catastrophizing behavior

  Measurement of changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week

Study Arms (3)

Control Group

ACTIVE COMPARATOR

NLP-supported patient education will be given and breath therapy will be applied to the Control Group

Other: Breathing exercise

Virtual Reality Group-1

EXPERIMENTAL

NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the three most painful points in the McGill-Melzack Pain Scale (real painful points) were given to this group in virtual reality environment.

Other: Breathing exercise

Virtual Reality Group-2

EXPERIMENTAL

NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the contralateral of the points reported as the three most painful points in the McGill-Melzack Pain Scale (virtual painful points) to this group in a virtual reality environment

Other: Breathing exercise

Interventions

Breathing exercise OTHER

Breathing exercises will include; 1. Correct posture and sitting 2. Nose opening techniques 3. Diaphragmatic breathing, which consists of continuous and deep nasal inspiration with movement of the abdominal region and diaphragm 4. Main Breathing exercise (during 5 minutes)=inspiration (during 5 seconds) + expiration (during 15 seconds).

Control Group; Virtual Reality Group-1; Virtual Reality Group-2

Eligibility Criteria

• Age: 25 Years - 55 Years
• Gender Eligibility Details: Fibromyalgia patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Nilüfer kablan

Istanbul, Kartal, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.

  PMID: 26088211 RESULT

• 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.

  PMID: 30453109 RESULT

• 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.

  PMID: 32616375 RESULT

• 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.

  PMID: 36749869 RESULT

• 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.

  PMID: 35579545 RESULT

• 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.

  PMID: 34231231 RESULT

• 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.

  PMID: 26773435 RESULT

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Nilüfer Kablan, PhD

  İstanbul Medeniyet Üniversitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nilüfer Kablan, PhD

CONTACT

05067638556; niluferkablan@yahoo.com

Tansu Birinci Olgun, PhD

CONTACT

0535 272 22 24; tansubirinci@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)