Neuropathic Pain in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

Evaluation of Neuropathic Pain in Patients With Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223049
• Other study ID #: 2020-06/95
• Status: Completed
• Start date: January 22, 2022
• Est. completion date: March 15, 2022

Study information

• Verified date: October 2022
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Neuralgia
• Psoriatic Arthritis

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disease activity in Psoriatic arthritis (DAPSA) score in two groups	The statistical difference between two groups in terms of disease activity	1 day
Primary	Numeric Rating Scale (rest, movement) in two groups	The statistical difference between two groups in terms of disease activity	1 day
Primary	Short form-36 survey in two groups	The statistical difference between two groups in terms of SF-36 and subdomains	1 day
Primary	SPARCC enthesitis index in two groups	he statistical difference between two groups in terms of SPARCC	1 day