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

Sponsor

Ahi Evran University Education and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04820426

Collaborator

(none)

Enrollment

Location

12.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Neuropathic Pain

Detailed Description

Synovial inflammation, which can lead to joint deformity by causing cartilage and bone destruction, is the main pathophysiological mechanism in rheumatoid arthritis, and therefore the main cause of pain in rheumatoid arthritis patients is thought to be nociceptive. Although pain in rheumatoid arthritis was previously associated with tissue damage and inflammatory processes in the joints, accumulated knowledge shows that peripheral inflammation, disease progression, structural and neurochemical changes in the joints and sensorial system, and central pain process mechanisms may also play a role in these rheumatoid arthritis patients.

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.

Although the frequency of neuropathic pain in rheumatoid arthritis patients varies in various clinical studies, it is approximately 20.7-30%. 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. 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 analogue scale), AIMS (Arthritis Impact Scale), EQ-5D (European Quality of Life Assessment and Pain Assessment Questionnaire).

Although non-steroidal anti-inflammatory drugs(NSAIDs) are used for pain in rheumatoid arthritis, it is not suitable for long-term disease control. It is important to start the use of disease-modifying agents (DMARDs) in the early period in patients.

Analgesic agents such as NSAIDs, acetaminophen, and opioids are used for pain in rheumatoid arthritis patients. However, some side effects of these drugs frequently limit their usage. Long-term opioid use in pain treatment is not recommended due to its side effects such as constipation, nausea and vomiting, and should be used with careful monitoring when necessary. Other drugs such as tricyclic antidepressants and topical capsaicin have been used in randomized controlled trials for pain management in RA with limited success.

Study Design

Study Type:

Observational

Anticipated Enrollment :

46 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Evaluation of presence of neuropathic pain [Participant's admission]
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.
Evaluation of participant's anxiety and depression [Participant's admission]
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.
Participants' quality of life assessed with Short Form-36 Scale [Participant's admission]
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.
Participants's body pain assessed by VAS [Participant's admission]
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).
Evaluation of rheumatoid arthritis disease activity [Participant's admission]
Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)
Evaluation of rheumatoid arthritis remission [Participant's admission]
Boolean index criteria will be used for detect the remission.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosed with rheumatoid arthritis,
who can read and write in Turkish,
participant's admission participating in the study,
participants who do not have exclusion criteria

Exclusion Criteria:

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.