Neuropathic Hand Pain in Rheumatoid Arthritis

NCT ID: NCT04839081

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2026-06-15

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

Detailed Description

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

RA patients

RA patients diagnosed according to the 1987 ACR Criteria

questionnaires and inventories

Intervention Type: OTHER

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

Control

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

questionnaires and inventories

Intervention Type: OTHER

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

Interventions

questionnaires and inventories

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

Intervention Type: OTHER

Other Intervention Names

physical examination

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taciser Kaya

Associate professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taciser Kaya, Assoc. prof

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Reseach Hospital

Locations

Izmir Bozyaka Training and Research Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 26335941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25600850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25620673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22243555 (View on PubMed)

Other Identifiers

45986TK

Identifier Type: -

Identifier Source: org_study_id