Neuropathic Pain in Psoriatic Arthritis

NCT05223049 | Completed

• 1 other identifier: 2020-06/95
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriatic Arthritis

Keywords

Neuropathic Pain; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (5)

• Frequency neuropathic pain in psoriatic arthritis patients

  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

  The statistical difference between two groups in terms of disease activity

  1 day

• Numeric Rating Scale (rest, movement) in two groups

  The statistical difference between two groups in terms of disease activity

  1 day

• Short form-36 survey in two groups

  The statistical difference between two groups in terms of SF-36 and subdomains

  1 day

• SPARCC enthesitis index in two groups

  he statistical difference between two groups in terms of SPARCC

  1 day

Study Arms (2)

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; Other: Douleur Neuropathique 4 questionnaire (DN4); Other: Short form-36; Other: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC); Other: Numeric Rating Scale; Other: Disease activity in psoriatic arthritis (DAPSA)

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; Other: Douleur Neuropathique 4 questionnaire (DN4); Other: Short form-36; Other: Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC); Other: Numeric Rating Scale; Other: Disease activity in psoriatic arthritis (DAPSA)

Interventions

painDETECT questionnaire OTHER

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.

Psoriatic Arthritis patients with neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Douleur Neuropathique 4 questionnaire (DN4) OTHER

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.

Psoriatic Arthritis patients with neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Short form-36 OTHER

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.

Psoriatic Arthritis patients with neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC) OTHER

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.

Psoriatic Arthritis patients with neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Numeric Rating Scale OTHER

Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.

Psoriatic Arthritis patients with neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Disease activity in psoriatic arthritis (DAPSA) OTHER

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 neuropathic pain; Psoriatic Arthritis patients with nonneuropathic pain

Eligibility Criteria

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

Study Population

Adult psoriatic arthritis patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (2)

• Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.

  PMID: 18003941 BACKGROUND

• Ramjeeawon A, Choy E. Neuropathic-like pain in psoriatic arthritis: evidence of abnormal pain processing. Clin Rheumatol. 2019 Nov;38(11):3153-3159. doi: 10.1007/s10067-019-04656-5. Epub 2019 Jul 19.

  PMID: 31325065 BACKGROUND

MeSH Terms

Conditions

Arthritis, Psoriatic; Neuralgia

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 3, 2022
• Study Start: January 22, 2022
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)