Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria

Female patients aged 18-65

Being literate

Having signed the informed consent form upon agreeing to participate in the study

Disqualifiers

Being under 18 or over 65 years of age

Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)

Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)

Peripheral artery disease

Trial population

The study population will consist of female patients who presented to the Physical Medicine and Rehabilitation Clinic and received a diagnosis of FM.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Quantitative Sensory Tests(QST) protocol

    Other intervention

    including PPT Measurement with an Algometer, CPM and the Slow-Repeated Stimulated Pain Assessment Protocol

  • Clinical Scales

    Other intervention

    Central Sensitization Inventory, Revised Fibromyalgia Impact Questionnaire, S-LANSS, Tampa Kinesiophobia Scale, Hospital Anxiety and Depression Scale, SF-12 Quality of Life Scale and Fatigue Severity Scale

Treatment groups

82 Participants
are divided into 1 treatment group
Group A: Patient2 interventions

Trial outcomes

Primary outcomes

1

Conditioned Pain Modulation

Objective determination of the pain modulation phenotype and the severity of central sensitization. Scores above 100 are considered a normal CPM response; higher scores indicate greater pain inhibition.

Time frame
Baseline

Secondary outcomes

1

Pressure Pain Threshold

Lower values are associated with pain sensitization

Time frame
Baseline
2

Slowly Repeated Evoked Pain Assessment Protocol

The SREP protocol consists of 9 painful stimuli above the pain threshold, each applied to the nail for 5 seconds at approximately 30-second intervals.

Time frame
Baseline
3

Central Sensitization Inventory

It is preferred for investigating pain sensitivity through symptoms associated with CS and related comorbidities. CS severity can be classified into 5 different groups based on the score obtained from Section A of the scale: scores of 0-21 indicate a subclinical level, 22-30 indicate a mild level, 31-37 indicate a moderate level, 38-51 indicate a severe level, and scores above 51 indicate a very severe level of CS .

Time frame
Baseline
4

Revised Fibromyalgia Impact Questionnaire

It consists of three sections-daily physical activities, general condition, and symptoms-and a total of 21 questions. It assesses limitations and functional disability in patients with fibromyalgia. All questions are rated on a 0-10-point Visual Analog Scale (VAS). A higher total score indicates an increase in disability associated with fibromyalgia.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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