Neuropathic Hand Pain in Rheumatoid Arthritis

NCT04839081 | Active Not Recruiting

• 1 other identifier: 45986TK
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Neuropathic pain

  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

  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

Secondary Outcomes (2)

• Light touch-pressure threshold

  Once, at baseline

• Depression

  Once, at baseline

Study Arms (2)

RA patients

RA patients diagnosed according to the 1987 ACR Criteria

Other: questionnaires and inventories

Control

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

Other: questionnaires and inventories

Interventions

questionnaires and inventories OTHER

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

Also known as: physical examination

Control; RA patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Being diagnosed with RA according to the 1987 ACR Criteria
• Visual Analogue Scale hand pain score ≥ 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26335941 BACKGROUND

• 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.

  PMID: 25600850 BACKGROUND

• 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.

  PMID: 25620673 BACKGROUND

• 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.

  PMID: 22243555 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Surveys and Questionnaires; Equipment and Supplies; Restraint, Physical

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Taciser Kaya, Assoc. prof

  Izmir Bozyaka Training and Reseach Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: April 26, 2021
• Primary Completion: May 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

TU (1)