The Effect of Perception of Improvement in Patients With Fibromyalgia

Istanbul Medeniyet University39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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).

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

Secondary Outcomes

Sleep Quality

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

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

Functional status and disease impact

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)

Time frame: 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

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)

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

Anxiety and Depression Status

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)

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

Pain catastrophizing behavior

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)

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

Patient satisfaction

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

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

Measurement of biomechanical characteristics of tissue

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.

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

Measurement of biomechanical characteristics of tissue

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.

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

Measurement of biomechanical characteristics of tissue

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.

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

Measurement of viscoelastic characteristics of tissue

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.

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

Measurement of viscoelastic characteristics of tissue

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.

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

The Effect of Perception of Improvement in Patients With Fibromyalgia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts