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Neuropatisk handsmärta vid reumatoid artrit

2 november 2026 uppdaterad av: Taciser Kaya, Bozyaka Training and Research Hospital

Neuropatiska egenskaper hos reumatoid handsmärta och dess samband med sensoriska trösklar och sömnkvalitet: en fallkontrollstudie

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

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Detaljerad beskrivning

Rheumatoid arthritis (RA) is a chronic, inflammatory rheumatic disease that predominantly affecting peripheral joints. Patients with RA are suffered from severe hand pain and functional loss because of synovitis in hand joints. The fact that patients with low disease activity may complain from hand pain suggests that pain is mediated by mechanisms other than inflammation. Contribution of central sensitization to pain sensation of RA patients is of interest currently. Several authors reported the neuropathic characteristics of hand pain in RA. Hand pain is primarily nociceptive in RA patients but the possibility of variances in cutaneous sensitivity due to nociceptive input from joints has been suggested. Increased sensitivity with light touch has been demonstrated over hands of RA patients. In RA patients, alterations in central processing of somatosensory function and allodynia over inflamed joints have been reported. Poor sleep quality is another issue for RA patients and it's association with pain was reported. However impact of neuropathic hand pain on sleep quality was not understood exactly probably due to the scarce of the studies investigating this association. Also, to the best of investigators' knowledge, the relation between neuropathic component of pain and sensory threshold alterations in rheumatoid hand was not studied to date.

So, 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 nociceptive/mechanical pain complaint other than in hand lasting more than three months. Also whether sensory thresholds in rheumatoid hands differ from healthy hands will be assessed. Participants in control group will be subjected to same exclusion criteria too.

This design will allow the investigators to determine whether hand pain in RA patients displays neuropathic character more frequently than any other chronic nociceptive pain does. Moreover, it will be possible to compare sensory thresholds between healthy and rheumatoid hand. RA patients diagnosed according to the 1987 American College of Rheumatology criteria will be recruited. Demographics and disease related variables will be recorded.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Izmir, Turkiet (Türkiye)
        • Izmir Bozyaka Training and Research Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

RA patients having hand pain with severity of 3 or more on 100 mm VAS and age- and sex-matched control subjects will be chosen among individuals submitting to our out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiv: CROSS_SECTIONAL

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
RA patients

RA patients diagnosed according to the 1987 ACR Criteria

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Andra namn:
  • fysisk undersökning
Control

Age- and sex-matched control subjects with nociceptive/mechanical pain complaint other than in hand, lasting more than three months

questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.

Andra namn:
  • fysisk undersökning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Neuropathic pain
Tidsram: 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

Once, at baseline
Sleep quality
Tidsram: 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.

Once, at baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Light touch-pressure threshold
Tidsram: Once, at baseline

It will be assessed using Semmes-Weinstein monofilament test composing of five filaments ranging in thickness from 2.83 to 6.65 mm and applying force ranging from 0.07 g to 300 g. The procedure is started by getting the thinnest filament in contact to relevant skin region. If it is not felt after three trials with same filament, examiner proceeds with the next more larger filament until touch felt by the patient.

Once, at baseline
Depression
Tidsram: Once, at baseline

It will be assessed using Beck Depression Inventory. It is is a 21-question multiple-choice self-report inventory quantifies the symptoms of depression. Each question is rated between 0 and 3 to reflect the intensity of statements. All points are summed arithmetically to obtain a total score which ranges between 0 and 63. Higher scores indicate more intense depressive symptoms.

Once, at baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Taciser Kaya, Assoc. prof, Izmir Bozyaka Training and Reseach Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 april 2021

Primärt slutförande (Faktisk)

15 maj 2025

Avslutad studie (Beräknad)

15 september 2027

Studieregistreringsdatum

Först inskickad

8 april 2021

Först inskickad som uppfyllde QC-kriterierna

8 april 2021

Första postat (Faktisk)

9 april 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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