Psoriatic ArthritisNCT05223049
Neuropathic Pain in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- painDETECT questionnaire, Douleur Neuropathique 4 questionnaire (DN4) and Short form-36
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2022to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult psoriatic arthritis patients
Who may be able to join
- being aged≥18
- being diagnosed PSA according to CASPAR criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- painDETECT questionnaire, Douleur Neuropathique 4 questionnaire (DN4), Short form-36, Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC), Numeric Rating Scale
- Keywords
- Neuropathic Pain, Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painDETECT questionnaireOther
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)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-36Other
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)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 ScaleOther
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Disease activity in Psoriatic arthritis (DAPSA) score in two groups
The statistical difference between two groups in terms of disease activity
Measured: 1 day
Numeric Rating Scale (rest, movement) in two groups
The statistical difference between two groups in terms of disease activity
Measured: 1 day
Short form-36 survey in two groups
The statistical difference between two groups in terms of SF-36 and subdomains
Measured: 1 day
SPARCC enthesitis index in two groups
he statistical difference between two groups in terms of SPARCC
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start22 Jan 2022
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223049
- Sponsor's protocol ID
- 2020-06/95
- Status last verified
- Oct 2022
- First submitted
- 23 Jan 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18003941Ramjeeawon 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.
PubMed 31325065
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuropathic Pain in Patients With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05223049
- Acronym / sponsor ID
- 2020-06/95
- Conditions
- Psoriatic Arthritis
- Keywords
- Neuropathic Pain, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis patients with neuropathic pain | – | 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)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. |
| Psoriatic Arthritis patients with nonneuropathic pain | – | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult psoriatic arthritis patients
Key inclusion criteria (2 listed)
- being aged≥18
- being diagnosed PSA according to CASPAR criteria
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| painDETECT questionnaireThe 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 | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic 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. | Other | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic pain |
| Short form-36The 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 | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic pain |
| 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 | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic pain |
| Numeric Rating ScaleSelf reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome. | Other | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic pain |
| 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). | Other | Psoriatic Arthritis patients with neuropathic pain, Psoriatic Arthritis patients with nonneuropathic pain |
Primary outcome
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.
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
Numeric Rating Scale (rest, movement) in two groups
Time frame: 1 day
The statistical difference between two groups in terms of disease activity
Short form-36 survey in two groups
Time frame: 1 day
The statistical difference between two groups in terms of SF-36 and subdomains
SPARCC enthesitis index in two groups
Time frame: 1 day
he statistical difference between two groups in terms of SPARCC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 18003941Treede 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.
- Background: PubMed 31325065Ramjeeawon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency neuropathic pain in psoriatic arthritis patients (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223049, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.