Pain Phenotypes in Patients with Fibromyalgia Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia, Primary
- Sponsor
- Kutahya Health Sciences University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Quantitative sensory test: static tactile mechanical threshold
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ismail Saracoglu
Director
Kutahya Health Sciences University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
- •severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
- •illiterate
- •problems with hearing and vision
Outcomes
Primary Outcomes
Quantitative sensory test: static tactile mechanical threshold
Time Frame: 10 minutes
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Quantitative sensory test: dynamic mechanical allodynia
Time Frame: 5 minutes
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.
Revised Fibromyalgia Impact Questionnaire
Time Frame: 10 minutes
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.
Quantitative sensory test: hot-cold pain threshold
Time Frame: 5 minutes
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.
Quantitative sensory test: vibration sense
Time Frame: 5 minutes
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.
The interview
Time Frame: 5 minutes
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.
Quantitative sensory test: static mechanical allodynia
Time Frame: 5 minutes
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.
Margolis Pain Diagram
Time Frame: one minute
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.
Numeric pain rating scale
Time Frame: one minute
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).
Short Form 12 (SF-12)
Time Frame: 10 minutes
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.
Pain Catastrophe Scale (PCS)
Time Frame: 10 minutes
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).
Secondary Outcomes
- Central Sensitization Inventory(10 minute)
- Douleur Neuropathique 4 Questionnaire(5 minutes)