Neuropathic Pain in Psoriatic Arthritis

NCT ID: NCT05223049

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-22

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

painDETECT questionnaire

Intervention Type 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.

Douleur Neuropathique 4 questionnaire (DN4)

Intervention Type 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.

Short form-36

Intervention Type 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.

Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)

Intervention Type 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.

Numeric Rating Scale

Intervention Type OTHER

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

Disease activity in psoriatic arthritis (DAPSA)

Intervention Type 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 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.

painDETECT questionnaire

Intervention Type 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.

Douleur Neuropathique 4 questionnaire (DN4)

Intervention Type 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.

Short form-36

Intervention Type 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.

Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)

Intervention Type 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.

Numeric Rating Scale

Intervention Type OTHER

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

Disease activity in psoriatic arthritis (DAPSA)

Intervention Type 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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Numeric Rating Scale

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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18003941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31325065 (View on PubMed)

Other Identifiers

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2020-06/95

Identifier Type: -

Identifier Source: org_study_id

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