Neuropathic Pain in Psoriatic Arthritis

October 4, 2022 updated by: Bezmialem Vakif University

Evaluation of Neuropathic Pain in Patients With Psoriatic Arthritis

Pathogenesis of inflammatory diseases is suitable for eliciting neuropathic pain. The aim of this study is to evaluate the frequency of NP among PsA patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neuropathic pain (NP) is the pain arising from a primary lesion or a dysfunction of nervous system. NP can affect central or peripheral nervous system and can be caused by numerous factors such as inflammation or neuroplastic changes. Inflammation can sensitize nociceptors in sensory nerves by promoting prostaglandin E2 and I2 secretion thus, cause neuropathic pain. Besides, a mixed pain pattern with neuropathic components is thought to be developed in chronic pain conditions. In this point of view, pathogenesis of inflammatory diseases is suitable for eliciting NP. In arthritic joints, even non-arthritic tissues are affected by the disease and a condition called peripheral sensitization develops. Previous studies about NP and inflammatory diseases link have focused on rheumatoid arthritis and number of studies about NP and psoriatic arthritis (PsA) is limited. In this manner the aim of this study is to evaluate the frequency of NP among PsA patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult psoriatic arthritis patients

Description

Inclusion Criteria:

  • being aged≥18
  • being diagnosed PSA according to CASPAR criteria

Exclusion Criteria:

  • additional conditions that could cause neuropathic pain (e.g. radiculopathy, polyneuropathy, depression, fibromyalgia)
  • history of fracture or surgery
  • endocrinopathies that could cause neuropathic pain (e.g. DM)
  • malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriatic Arthritis patients with neuropathic pain
Patients diagnosed with Psa according to The Classification Criteria for Psoriatic Arthritis (CASPAR) psoriatic arthritis criteria. Who has a DN4 score of ≥4 or PainDETECT score of ≥13.
Other: painDETECT questionnaire
The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. It is also used in detecting the neuropathic pain in rheumatic diseases. A score between ≤12 represents a nonneuropathic pain, ≥13 and ≤18 represents a possible neuropathic pain, while a score of ≥19 represents a neuropathic pain.
Other: Douleur Neuropathique 4 questionnaire (DN4)
DN4 is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. A score of ≥4 represents a neuropathic pain.
Other: Short form-36
The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. It comprises 36 questions which cover eight domains of health. 1) Limitations in physical activities because of health problems. 2) Limitations in social activities because of physical or emotional problems 3) Limitations in usual role activities because of physical health problems 4) Bodily pain 5) General mental health (psychological distress and well-being) 6) Limitations in usual role activities because of emotional problems 7) Vitality (energy and fatigue) 8) General health perceptions. Each domain is scored between 0 and 100 and a higher score represents a better outcome.
Other: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)
SPARCC was created as a measure for enthesitis in spondyloarthritis in general. It assesses 16 enthesial sites. Total number of the enthesitis is the total score of the evaluation. Total score is between 0 and 16, and higher scores represent a worse outcome.
Other: Numeric Rating Scale
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Other: Disease activity in psoriatic arthritis (DAPSA)
DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (< 4) and low disease activity (< 14).
Psoriatic Arthritis patients with nonneuropathic pain
Patients diagnosed with Psa according to The Classification Criteria for Psoriatic Arthritis (CASPAR) psoriatic arthritis criteria. Who has a DN4 score of ≤4 or PainDETECT score of ≤13.
Other: painDETECT questionnaire
The painDETECT questionnaire was specifically developed to detect neuropathic pain components in adult patients with low back pain. It is also used in detecting the neuropathic pain in rheumatic diseases. A score between ≤12 represents a nonneuropathic pain, ≥13 and ≤18 represents a possible neuropathic pain, while a score of ≥19 represents a neuropathic pain.
Other: Douleur Neuropathique 4 questionnaire (DN4)
DN4 is a clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. A score of ≥4 represents a neuropathic pain.
Other: Short form-36
The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. It comprises 36 questions which cover eight domains of health. 1) Limitations in physical activities because of health problems. 2) Limitations in social activities because of physical or emotional problems 3) Limitations in usual role activities because of physical health problems 4) Bodily pain 5) General mental health (psychological distress and well-being) 6) Limitations in usual role activities because of emotional problems 7) Vitality (energy and fatigue) 8) General health perceptions. Each domain is scored between 0 and 100 and a higher score represents a better outcome.
Other: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)
SPARCC was created as a measure for enthesitis in spondyloarthritis in general. It assesses 16 enthesial sites. Total number of the enthesitis is the total score of the evaluation. Total score is between 0 and 16, and higher scores represent a worse outcome.
Other: Numeric Rating Scale
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
Other: Disease activity in psoriatic arthritis (DAPSA)
DAPSA includes a 68/66 joint count summed with a patient global, patient pain score, and C- reactive protein level. The DAPSA provides a continuous score of arthritis activity and has validated cut points for remission (< 4) and low disease activity (< 14).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency neuropathic pain in psoriatic arthritis patients
Time Frame: 1 day
The frequency of neuropathic pain in the PSA patients included in the study according to painDETECT and DN4 scores.
1 day
Disease activity in Psoriatic arthritis (DAPSA) score in two groups
Time Frame: 1 day
The statistical difference between two groups in terms of disease activity
1 day
Numeric Rating Scale (rest, movement) in two groups
Time Frame: 1 day
The statistical difference between two groups in terms of disease activity
1 day
Short form-36 survey in two groups
Time Frame: 1 day
The statistical difference between two groups in terms of SF-36 and subdomains
1 day
SPARCC enthesitis index in two groups
Time Frame: 1 day
he statistical difference between two groups in terms of SPARCC
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2022

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

January 23, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-06/95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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