The Effect of Perception of Improvement in Patients With Fibromyalgia

NCT ID: NCT06508385

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2026-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

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

Group Type: ACTIVE_COMPARATOR

Breathing exercise

Intervention Type: 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).

Virtual Reality Group-1

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.

Group Type: EXPERIMENTAL

Breathing exercise

Intervention Type: 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).

Virtual Reality Group-2

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

Group Type: EXPERIMENTAL

Breathing exercise

Intervention Type: 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).

Interventions

Breathing exercise

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Nilufer Kablan

Assoc. prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilüfer Kablan, PhD

Role: PRINCIPAL_INVESTIGATOR

İstanbul Medeniyet Üniversitesi

Locations

Nilüfer kablan

Istanbul, Kartal, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

nilüfer Kablan, PhD

Role: CONTACT

niluferkablan@yahoo.com

05067638556

Tansu Birinci Olgun, PhD

Role: CONTACT

tansubirinci@hotmail.com

0535 272 22 24

Facility Contacts

Nilüfer Kablan

Role: primary

niluferkablan@yahoo.com

05067638556

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 26773435 (View on PubMed)

Other Identifiers

2023/0689

Identifier Type: -

Identifier Source: org_study_id