The Effect of Perception of Improvement in Patients With Fibromyalgia

ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-55
SponsorIstanbul Medeniyet University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Breathing exercise

    Other intervention

    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).

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Virtual Reality Group-1Experimental treatment 1 intervention
Group C: Virtual Reality Group-2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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.
3

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
4

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

Other outcomes

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