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NCT Number: NCT06508385

The Effect of Perception of Improvement in Patients With Fibromyalgia

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.

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Key information

Conditions

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

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nilüfer kablan

Istanbul, Kartal, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nilüfer Kablan

CONTACT

[email protected]

05067638556

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing exercise

Other

Breathing exercises will include;

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

Primary outcomes

  1. Functional Magnetic Resonance

    Time frame: Measurement of changes from baseline process of processing pain will be measured at 6 week and 10 week

    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.

  2. Measurement of pain-pressure threshold

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

    Pain-pressure threshold evaluated with a pain threshold measuring device (Algometer).

Secondary outcomes

  1. Sleep Quality

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

    Sleep quality will be evaluated with Pittsburgh Sleep Quality Index. Score is between 0 (the best sleep quality) and 21 (the worst sleep quality)

  2. Functional status and disease impact

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

    Functional status and disease impact will be evaluated with Revised Fibromyalgia Impact Questionnaire. Score is between 0 (no disease impact and 100 (the highest disease impact)

  3. Quality of Life of patients

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

    Quality of Life will be measured with QOL Short Form 12. Score is between 0 (the lowest quality of life and 100 (the highest quality of life)

  4. Anxiety and Depression Status

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

    Anxiety and Depression will be evaluated with Hospital Anxiety and Depression Scale. Score is between 0 (no anxiety and depression risk) and 21 (the highest anxiety and depression risk)

  5. Pain catastrophizing behavior

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

    Assessing pain catastrophizing behavior will be evaluated with Pain Catastrophizing Scale. Score is between 0 (no pain catastrophizing behavior) and 52 (the highest pain catastrophizing behavior)

  6. Patient satisfaction

    Time frame: Measurement of changes from baseline of patient satisfaction will be measured at 6 week and 10 week

    Patient satisfaction will be evaluated with Global Rating of Change. No score is defined.

  7. Measurement of biomechanical characteristics of tissue

    Time frame: Measurement of changes from baseline stiffness values of tissue will be measured at 6 week and 10 week]

    Stiffness values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

    Stiffness values 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.

  8. Measurement of biomechanical characteristics of tissue

    Time frame: Measurement of changes from baseline tone values of tissue will be measured at 6 week and 10 week]

    Tone values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

    Tone values 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.

  9. Measurement of biomechanical characteristics of tissue

    Time frame: Measurement of changes from baseline decrement values of tissue will be measured at 6 week and 10 week]

    Decrement values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

    Decrement values 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.

  10. Measurement of viscoelastic characteristics of tissue

    Time frame: Measurement of changes from baseline creep values of tissue will be measured at 6 week and 10 week]

    Creep values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

    Creep values 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.

  11. Measurement of viscoelastic characteristics of tissue

    Time frame: Measurement of changes from baseline relaxation time values of tissue will be measured at 6 week and 10 week]

    Relaxation time values of tissue will be measured with myotonPro B1 over the three most painful points in Control Group and Virtual Reality-1 Group.

    Relaxation time values 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tansu Birinci Olgun, PhD

CONTACT

[email protected]

0535 272 22 24

nilüfer Kablan, PhD

CONTACT

[email protected]

05067638556

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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