Dolore neuropatico alla mano nell'artrite reumatoide
Caratteristiche neuropatiche del dolore reumatoide alla mano e la sua relazione con le soglie sensoriali e la qualità del sonno: uno studio caso-controllo
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Izmir, Turchia (Türkiye)
- Izmir Bozyaka Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
Inclusion Criteria:
- Being diagnosed with RA according to the 1987 ACR Criteria
- Visual Analogue Scale hand pain score ≥ 3
Exclusion Criteria:
- Diabetes mellitus, renal insufficiency, hypothyroidism
- Carpal tunnel syndrome, postherpetic neuralgia, cervical spinal cord compression
- Cervical radiculopathy
- Fibromyalgia
- Malignancy
- Hand muscle weakness of even one grade on Medical Research Council Manual Muscle Testing scale
- Upper motor neuron sign on physical examination of hands
- Pregnancy
- In the last three months medical treatment leading to neuropathy (colchicine etc.)
- In the last three months drug use for the treatment of fibromyalgia, depression or anxiety
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_CONTROL
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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.
Altri nomi:
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Neuropathic pain
Lasso di tempo: Once, at baseline
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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
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Sleep quality
Lasso di tempo: Once, at baseline
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Light touch-pressure threshold
Lasso di tempo: Once, at baseline
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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
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Depression
Lasso di tempo: Once, at baseline
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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
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Taciser Kaya, Assoc. prof, Izmir Bozyaka Training and Reseach Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Koop SM, ten Klooster PM, Vonkeman HE, Steunebrink LM, van de Laar MA. Neuropathic-like pain features and cross-sectional associations in rheumatoid arthritis. Arthritis Res Ther. 2015 Sep 3;17(1):237. doi: 10.1186/s13075-015-0761-8.
- Joharatnam N, McWilliams DF, Wilson D, Wheeler M, Pande I, Walsh DA. A cross-sectional study of pain sensitivity, disease-activity assessment, mental health, and fibromyalgia status in rheumatoid arthritis. Arthritis Res Ther. 2015 Jan 20;17(1):11. doi: 10.1186/s13075-015-0525-5.
- Loppenthin K, Esbensen BA, Jennum P, Ostergaard M, Tolver A, Thomsen T, Midtgaard J. Sleep quality and correlates of poor sleep in patients with rheumatoid arthritis. Clin Rheumatol. 2015 Dec;34(12):2029-39. doi: 10.1007/s10067-015-2875-4. Epub 2015 Jan 27.
- Ulus Y, Akyol Y, Tander B, Durmus D, Bilgici A, Kuru O. Sleep quality in fibromyalgia and rheumatoid arthritis: associations with pain, fatigue, depression, and disease activity. Clin Exp Rheumatol. 2011 Nov-Dec;29(6 Suppl 69):S92-6. Epub 2012 Jan 3.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie muscoloscheletriche
- Artrite
- Malattie articolari
- Malattie reumatiche
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie della pelle e del tessuto connettivo
- Artrite, reumatoide
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Metodi epidemiologici
- Terapie
- Raccolta dei dati
- Meccanismi di valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Sanità pubblica
- Ambiente e salute pubblica
- Controllo del comportamento
- Immobilizzazione
- Sondaggi e questionari
- Moderazione, fisico
- Attrezzatura e forniture
Altri numeri di identificazione dello studio
- 45986TK
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