Evaluation of the Effect of Neuropathic Pain on Quality of Life in Rheumatoid Arthritis Patients

NCT04820426 | Completed

• 1 other identifier: 2021-06/55
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis is a chronic inflammatory disease that mainly affects the joint synovium. Rheumatoid arthritis patients define pain as their major symptom and the most important reason for applying to a healthcare institution. Approximately 70% of rheumatoid arthritis patients state that improvement in their pain compared to other symptoms of the disease is their priority. Pain in rheumatoid arthritis patients is also important as the disease affects approximately 0.5-1% of patients worldwide. Although pain in rheumatoid arthritis patients can be persistent or intermittent, localized or widespread, it has often been associated with fatigue and psychosocial stress. Although nociceptive pain,defined as 'gnawing' or 'aching', is frequently observed in rheumatoid arthritis patients, typical neuropathic pain,such as 'burning' or 'itching', can be observed in some RA patients. It is thought that neuropathic pain may occur as a result of lesions or disease affecting the somatosensorial nervous system. Neuropathic pain can occur with little or no stimulus, and its symptoms are abnormal sensations such as hyperalgesia and allodynia. The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life. In order to distinguish neuropathic pain from chronic pain, methods based on defining the quality of pain are often used. Some of these methods are; The McGill Pain Questionnaire, PainDETECT, RAPS (Rheumatoid Arthritis Pain Scale), VAS (visual analog scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire). The diagnosis and treatment of neuropathic pain in rheumatoid arthritis patients is important because neuropathic pain does not decrease with traditional disease-modifying anti-inflammatory drugs used in rheumatoid arthritis and causes a decrease in quality of life.

Conditions

Rheumatoid Arthritis; Neuropathic Pain

Keywords

rheumatoid arthritis; neuropathic pain; pain in rheumatoid arthritis

Outcome Measures

Primary Outcomes (6)

• Evaluation of presence of neuropathic pain

  With the "Mc Gill-Mellzack Pain Questionnaire" form, the location of the patients' pain, the nature and intensity of the pain and the relationship between time and pain will be questioned.

  Participant's admission

• Evaluation of participant's anxiety and depression

  Participant's anxiety and depression will be measured with Hospital Anxiety and Depression Scale (HADS). The Scale contains 14 questions.(7 anxiety and 7 depression) Each question is scored 0 to 3. 8-10 scores mild, 11-14 scores moderate, 15-21 severe Anxiety and depression score will be measured separately.

  Participant's admission

• Participants' quality of life assessed with Short Form-36 Scale

  SF-36 scale, which is a quality of life assessment scale and has 36 questions, will be used to learn the participants' views about their own health, how they feel and how well they can perform daily activities.

  Participant's admission

• Participants's body pain assessed by VAS

  Pain will be questioned with Visual Analog Scale.(VAS) Visual Analog Scale is determined by measuring the distance (mm) on the 10 cm line, between anchor and the patient's mark. Providing a range of scores from 0-100.A higher score indicates greater pain intensity. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

  Participant's admission

• Evaluation of rheumatoid arthritis disease activity

  Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)

  Participant's admission

• Evaluation of rheumatoid arthritis remission

  Boolean index criteria will be used for detect the remission.

  Participant's admission

Study Arms (1)

Rheumatoid Arthritis patients

Rheumatoid arthritis patients will be evaluated in terms of the presence of neuropathic pain and its effect on the quality of life, at their admission.

Eligibility Criteria

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

Study Population

Rheumatoid arthritis patients

You may qualify if:

• diagnosed with rheumatoid arthritis,
• who can read and write in Turkish,
• participant's admission participating in the study,

You may not qualify if:

• participant's refusal to participate in the study,
• lack of cooperation due to cognitive impairment,
• participant's who have a neurological disease,
• presence of drug abuse,
• presence of malignancy in any organ or system,
• serious psychiatric problems (psychosis, etc.),
• the presence of another rheumatological disease other than Rheumatoid Arthritis,
• serious and unstable metabolic disease.

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Ahi Evran University Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (4)

• Noda K, Tajima M, Oto Y, Saitou M, Yoshiga M, Otani K, Yoshida K, Kurosaka D. How do neuropathic pain-like symptoms affect health-related quality of life among patients with rheumatoid arthritis?: A comparison of multiple pain-related parameters. Mod Rheumatol. 2020 Sep;30(5):828-834. doi: 10.1080/14397595.2019.1650462. Epub 2019 Aug 9.

  PMID: 31398076 BACKGROUND

• Ito S, Kobayashi D, Murasawa A, Narita I, Nakazono K. An Analysis of the Neuropathic Pain Components in Rheumatoid Arthritis Patients. Intern Med. 2018 Feb 15;57(4):479-485. doi: 10.2169/internalmedicine.9235-17. Epub 2017 Dec 8.

  PMID: 29225253 BACKGROUND

• Bas DB, Su J, Wigerblad G, Svensson CI. Pain in rheumatoid arthritis: models and mechanisms. Pain Manag. 2016;6(3):265-84. doi: 10.2217/pmt.16.4. Epub 2016 Apr 18.

  PMID: 27086843 BACKGROUND

• 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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Neuralgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• FIGEN TUNCAY, PROF.,M.D.

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)