questionnaires and inventories: questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
Study summary
Investigators have aimed to estimate prevalence of neuropathic hand pain in RA patients and it's relation with sleep quality and sensory thresholds. For this purpose a case-control study design was planned. Age- and sex-matched control subjects will be chosen among individuals submitted to out-patient clinic with the complaint of nociceptive/mechanical pain other than in hand, lasting more than three months
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Being diagnosed with RA according to the 1987 ACR Criteria
2. Visual Analogue Scale hand pain score ≥ 3
Exclusion Criteria:
1. Diabetes mellitus, renal insufficiency, hypothyroidism
2. Carpal tunnel syndrome, postherpetic neuralgia, cervical spinal cord compression
3. Cervical radiculopathy
4. Fibromyalgia
5. Malignancy
6. Hand muscle weakness of even one grade on Medical Research Council Manual Muscle Testing scale
7. Upper motor neuron sign on physical examination of hands
8. Pregnancy
9. In the last three months medical treatment leading to neuropathy (colchicine etc.)
10. In the last three months drug use for the treatment of fibromyalgia, depression or anxiety
Primary outcome measure(s)
Neuropathic pain — Once, at baseline It will be assessed using the painDETECT questionnaire. This questionnaire, contains nine questions all of which are selfreport. Seven items are rated on a six point Likert scale and thus are scored between 0-5. These seven questions query some sensations such as burning, tingling or prickling, allodynia, numbness etc. Apart from these seven items, one item assesses the radiation of pain and the other one item looks for the temporal characteristics of pain. A total score of 12 or less indicates neuropathic component is unlikely, 13-18 means possible neuropathic component and19 or greater means a neuropathic component is likely. Beside these, there are three items in a separate section measuring severity of pain at the time of evaluation, on average and maximum over the past month. This section is not taken into account in scoring
Sleep quality — Once, at baseline It will be assessed using Pittsburgh Sleep Quality Index (PSQI). It was developed by Buysse and coworkers in 1989.
This index measures sleep quality quantitatively and covers 24 questions. Nineteen questions are self-rated and scoring is based on these self-rated questions, other five questions that rating by partner are not taken into account while calculating total score. Questionnaire measures seven domains; subjective sleep quality (question 6), sleep latency (question 2 and 5a), sleep duration (question 4), habitual sleep efficiency (question 1,3,4), sleep disturbances (question 5b-j), use of sleep medication (question 7), and daytime dysfunction (question 8 and 9) over the last month.
Seven domain scores give a result on a 0 to 3 scale. To yield a total score the domain scores are summed. Total score varies between 0 and 21. Higher scores indicate worse sleep quality.
Trial sites (1)
Facility
City
Region
Status
Izmir Bozyaka Training and Research Hospital
Izmir
Turkey (Türkiye)
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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