Actively Recruiting

Phase Not Applicable
Age: 25Years - 55Years
FEMALE
NCT06508385

The Effect of Perception of Improvement in Patients With Fibromyalgia

Led by Istanbul Medeniyet University · Updated on 2024-09-19

39

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The Effect of Perception of Improvement in Patients With Fibromyalgia

Who Can Participate

Age: 25Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria
  • Age range 25-55 years
  • Female gender
  • 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
  • On a stable dose of medication for at least 6 months (such as serotonin norepinephrine reuptake inhibitors, alpha 2-delta receptor ligands, or gabapentinoids)
Not Eligible

You will not qualify if you...

  • Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, or uncontrolled endocrine diseases
  • Body Mass Index (BMI) of 30 Kg/m2 or higher
  • Being pregnant
  • Inability to understand, read, or speak Turkish
  • Difficulty in hearing or seeing
  • Having any metallic or electronic device in the body incompatible with the magnetic field in the fMRI scan
  • Having any serious disease diagnosis that may prevent participation (such as psychotic disorder, delirium, mental retardation, epilepsy, heart disease, lung diseases)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nilüfer kablan

Istanbul, Kartal, Turkey (Türkiye)

Actively Recruiting

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Research Team

N

nilüfer Kablan, PhD

CONTACT

T

Tansu Birinci Olgun, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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