The Effect of Perception of Improvement in Patients With Fibromyalgia

July 12, 2024 updated by: Nilufer Kablan, Istanbul Medeniyet University

The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
NLP-supported patient education will be given and breath therapy will be applied to the Control Group
Other: 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).
Experimental: 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.
Other: 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).
Experimental: 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
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Magnetic Resonance
Time Frame: 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.
changes from baseline process of processing pain will be measured at 6 week and 10 week
Measurement of Pain Intensity
Time Frame: changes from baseline of pain will be measured at 6 week and 10 week
Pain will be evaluated by McGill-Melzack Pain Scale.
changes from baseline of pain will be measured at 6 week and 10 week
Measurement of pain-pressure threshold
Time Frame: 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 with functional MRI. The device was specially developed for the study.
changes from baseline of pain-pressure threshold will be measured at 6 week and 10 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of biomechanical and viscoelastic characteristics of tissue
Time Frame: changes from baseline of biomechanical and viscoelastic characteristics of tissue will be measured at 6 week and 10 week]

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

Biomechanical and viscoelastic characteristics 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.
changes from baseline of biomechanical and viscoelastic characteristics of tissue will be measured at 6 week and 10 week]
Sleep Quality
Time Frame: 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
changes from baseline of sleep quality will be measured at 6 week and 10 week
Functional status and disease impact
Time Frame: 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
changes from baseline of functional status and disease impact will be measured at 6 week and 10 week
Quality of Life of patients
Time Frame: 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
changes from baseline of quality of life will be measured at 6 week and 10 week
Anxiety and Depression Status
Time Frame: 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
changes from baseline of anxiety and depression status will be measured at 6 week and 10 week
Pain catastrophizing behavior
Time Frame: 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
changes from baseline of changes from baseline of pain catastrophizing behaviors will be measured at 6 week and 10 week
Patient satisfaction
Time Frame: 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
changes from baseline of patient satisfaction will be measured at 6 week and 10 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Principal Investigator: Nilüfer Kablan, PhD, Istanbul Medeniyet Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0689

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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