Pain Phenotypes in Patients With Fibromyalgia Syndrome

NCT05941780 | Completed

• 1 other identifier: painclassificationFMS
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia Syndrome (FMS); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. It has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. Despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients. The primary aim of this study is to determine the chronic pain phenotypes in individuals with FMS. The secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with FMS in terms of pain severity, disease severity, quality of life and catastrophe.

Conditions

Fibromyalgia, Primary; Fibromyalgia; Chronic Pain Syndrome; Pain, Neuropathic; Nociceptive Pain; Central Sensitisation

Outcome Measures

Primary Outcomes (11)

• Quantitative sensory test: static tactile mechanical threshold

  Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.

  10 minutes

• Quantitative sensory test: hot-cold pain threshold

  Coins will be used for the hot-cold pain threshold. The cold sensing test will be done with a coin held at room temperature. The hot sensing test will be done in the form of a coin placed in the pocket and applied to the participant after waiting for 30 minutes.

  5 minutes

• Quantitative sensory test: static mechanical allodynia

  A digital algometer device (JTech) will be used for static mechanical allodynia (pressure pain threshold). In the device, the pain sensation will be tested by applying 4 kg of pressure to the participant.

  5 minutes

• Quantitative sensory test: dynamic mechanical allodynia

  A soft brush will be used for dynamic mechanical allodynia. The brush will be gently moved over the skin at a speed of 3-5 cm per second in a fixed direction over the patients primary painful area.

  5 minutes

• Quantitative sensory test: vibration sense

  128 Hz tuning fork will be used in vibration assessment. The device will be applied over the bony prominences in the painful area of the patient.

  5 minutes

• Margolis Pain Diagram

  The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain \[20\]. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours.

  one minute

• Numeric pain rating scale

  The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  one minute

• Revised Fibromyalgia Impact Questionnaire

  Disease Severity and perceived physical function will be assessed with the "Revised Fibromyalgia Impact Questionnaire (FIQ-R)" consists of 21 questions in total. All questions in this questionnaire are rated on an 11-point numerical scale from 0 to 10, with 10 indicating the worst possible situation.

  10 minutes

• Short Form 12 (SF-12)

  Quality of Life will be assessed with the SF-12 scale. SF-12, physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item), emotional role (2 items) and mental health (2 items) and includes 8 sub-dimensions and 12 items in total. Both components range from 0 to 100, with a higher score representing better health.

  10 minutes

• Pain Catastrophe Scale (PCS)

  Catastrophe will be assessed by the Pain Catastrophe Scale (PCS). The PCS is a 13-item self-report scale using a 5-point Likert scale (0-4).

  10 minutes

• The interview

  Clinical history and patient interview will be done. The researcher will evaluate the symptoms of hypersensitivity based on the patient's clinical history. Besides, the researcher will evaluate whether the patient has increased sensitivity to odors, lights or sounds. Also, the researcher evaluates the patient's conditions such as fatigue, sleep disorders, and cognitive problems.

  5 minutes

Secondary Outcomes (2)

• Central Sensitization Inventory

  10 minute

• Douleur Neuropathique 4 Questionnaire

  5 minutes

Interventions

Pain classification method DIAGNOSTIC_TEST

A current clinical algorithm will be used to determine the predominant type of pain in individuals with FMS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with FMS who apply to Pamukkale University Rheumatology Clinic will be screened for eligibility by their clinic physicians and will then be asked to participate in this study

You may qualify if:

• being diagnosed with fibromyalgia syndrome according to the criteria of the American Rheumatology Association ,
• not receiving active treatment related to physiotherapy,
• volunteering to participate in the study

You may not qualify if:

• diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
• severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
• illiterate
• problems with hearing and vision

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Pamukkale University Hospitals

Denizli, Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Neuralgia; Nociceptive Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ismail Saracoglu, P.hD.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 12, 2023
• Study Start: July 10, 2023
• Primary Completion: November 28, 2023
• Study Completion: January 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

TU (1)