Arthritis, PsoriaticNCT03703934
Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
An observational study of Arthritis, Psoriatic and Hand Osteoarthritis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
In this trial different parts of the pain signalling system involved in two rheumatic diseases - painful hand osteoarthritis and psoriatic arthritis, is examined. These measurements will be compared to those of healthy volunteers The hypothesis is that patients with hand osteoarthritis and psoriatic arthritis react… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Psoriatic, Hand Osteoarthritis
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Oct 2018to 30 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: PsA and Hand-OA patients will be picked from primary and secondary care. Healthy volunteers will be picked from the community.
Who may be able to join
- Patients (above 18 years) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)
- Hand-OA of the phenotype: Nodal, Non-erosive.
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment.
- Patients (over 18 years) with PsA according to the Clarification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
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- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum human chorionic gonadotropin (HCG)) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment.
- Men and women age over18 years
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
Who cannot join
- Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout) *
- Erosive Hand-OA (One or more erosive joints on plain x-ray)
- Isolated Hand-OA of the first metacarpal joint or this joint as the most painful*
- Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
- Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowl disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
- Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
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- Planned major surgery or recent major surgery (last 8weeks)
- Verified malignant disease
- History of epilepsy or severe cramps
- History of serious cardiovascular pathology
- Lacking ability to corporate with the research staff.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Rheumatology Aalborg Universityhospital North
Aalborg, 9000
About this study
In this trial different parts of the pain signalling system involved in two rheumatic diseases - painful hand osteoarthritis and psoriatic arthritis, is examined. These measurements will be compared to those of healthy volunteers
The hypothesis is that patients with hand osteoarthritis and psoriatic arthritis react differently to painful and non-painful stimuli compared with the healthy volunteers.
Read more
The aim is to recruit 66 patients with painful hand-osteoarthritis, 66 patients with painful psoriatic arthritis and 66 healthy subjects not currently suffering from any pain conditions.
After completing an informed consent form subjects will participate in a single clinical visit. The pain signalling system is examined using pressure algometry and cuff algometry. A pressure algometer is a pistol shaped device that elicits pressure through a rod and a cuff algometer is akin to a blood pressure cuff. Different thresholds will be measured, such as when the sensation of pressure becomes painful and when the painful pressure becomes unbearable.
Participants will also get hand strength tested, have their joints examined and answer questionnaires regarding daily function and quality of life.
Furthermore participants will get blood drawn which is analysed for the presence of markers of inflammation and joint degeneration.
Read the detailed description
Purpose and rationale for this study:
Treating painful hand osteoarthritis (Hand-OA) and psoriatic arthritis (PsA) is a clinical challenge because the exact pain mechanisms remain unknown. Both conditions seem to involve both central and peripheral pain mechanisms and inflammation to some degree. However, it remains unknown whether the pain mechanisms are homogenous among patients with said conditions or if different pain phenotypes exist that may respond differently to treatments.
The initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consortium has recognized this. IMMPACT recommends that clinical trials with chronic pain patients assess different domains of the pain experience (psychosocial, pain qualities, sleep, and pain pathways) to examine if pain phenotypes exist and whether different treatment modalities are more effective for certain phenotypes.
Methods: A cross-sectional study examining the difference in pain phenotype and pain mechanisms between patients with Hand-OA, PsA and healthy pain free controls using questionnaire assessments and quantitative sensory testing aiming at investigating pain pathways in the central nervous system. Participants will also have blood drawn to evaluate serological biomarkers for inflammation and joint degeneration.
Aim: To examine the pain phenotypes and assess differences in pressure pain threshold between patients with Hand-OA, PsA and healthy pain free controls.
Patients and controls: Patients with nodal non-erosive Hand-OA or PsA and visual analogue scale for pain (VAS pain) during the last 24hours of 30mm or more.
Controls are healthy age and gender matched subjects with no known chronic pain conditions and maximal pain during last 24 hours under 10mm on a 100mm VAS.
Examination programme: All participants will receive a full medical interview and a physical examination which includes auscultation, blood pressure, heart rate and saturation measurements and BMI calculation. All participants will have blood drawn for later examination for markers of inflammation and degeneration. All participants will go through Quantitative Sensory Testing (QST). QST covers a wide range of different examinations techniques used to assess the functional status of the somatosensory system33. In the present study pressure algometry and cuff algometry will be performed.
Pain phenotyping: Participants will answer a series of questionnaires related to the pain experience to assess: Anxiety and depression (the hospital anxiety and depression scale), pain catastrophizing (the pain catastrophizing scale), pain description (The short form McGill questionnaire and pain detect questionnaire), sleep quality (Pittsburgh sleep quality index) and a widespread pain assessment questionnaire. To assess function and quality of life the Short form 36 and Health assessment questionnaire will be used.
Patients with PsA: Will receive an examination for disease specific tests including: joint tenderness and swelling using the European league against rheumatism (EULAR) 66/68 regiment, dactylitis evaluation using Leeds dactylitis index basic, skin involvement using the psoriasis area and severity index and nail psoriasis via nail psoriasis severity index.
Patients with Hand-OA: Will receive the following disease specific examinations evaluation of tender and swollen joints of the hands and wrists. Grip and pinch strength measurements using a hand-held dynamometer.
- Conditions
- Arthritis, Psoriatic, Hand Osteoarthritis
- Keywords
- Pain phenotyping, Quantitative sensory testing
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Patients with painful psoriatic arthritis | |
| Hand Osteoarthritis | Patients with painful nodal non-erosive hand osteoarthritis | |
| Healthy Controls | Patients without a painful condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group difference in Pressure pain threshold (PPT)
Difference PPT between groups measured in kPa
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start20 Oct 2018
- Primary completion1 Apr 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Jonathan Vela, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703934
- Sponsor's protocol ID
- 210417
- Status last verified
- Jan 2021
- First submitted
- 1 Oct 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vela J, Dreyer L, Petersen KK, Arendt-Nielsen L, Duch KS, Amris K, Kristensen S. Quantitative sensory testing, psychological profiles and clinical pain in patients with psoriatic arthritis and hand osteoarthritis experiencing pain of at least moderate intensity. Eur J Pain. 2024 Feb;28(2):310-321. doi: 10.1002/ejp.2183. Epub 2023 Sep 15.
PubMed 37712295
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
- ClinicalTrials.gov ID
- NCT03703934
- Acronym / sponsor ID
- 210417
- Conditions
- Arthritis, Psoriatic, Hand Osteoarthritis
- Keywords
- Pain phenotyping, Quantitative sensory testing
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 12 Oct 2018 (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.
In this trial different parts of the pain signalling system involved in two rheumatic diseases - painful hand osteoarthritis and psoriatic arthritis, is examined. These measurements will be compared to those of healthy volunteers
The hypothesis is that patients with hand osteoarthritis and psoriatic arthritis react differently to painful and non-painful stimuli compared with the healthy volunteers.
The aim is to recruit 66 patients with painful hand-osteoarthritis, 66 patients with painful psoriatic arthritis and 66 healthy subjects not currently suffering from any pain conditions.
After completing an informed consent form subjects will participate in a single clinical visit. The pain signalling system is examined using pressure algometry and cuff algometry. A pressure algometer is a pistol shaped device that elicits pressure through a rod and a cuff algometer is akin to a blood pressure cuff. Different thresholds will be measured, such as when the sensation of pressure becomes painful and when the painful pressure becomes unbearable.
Participants will also get hand strength tested, have their joints examined and answer questionnaires regarding daily function and quality of life.
Furthermore participants will get blood drawn which is analysed for the presence of markers of inflammation and joint degeneration.
Detailed description
Purpose and rationale for this study:
Treating painful hand osteoarthritis (Hand-OA) and psoriatic arthritis (PsA) is a clinical challenge because the exact pain mechanisms remain unknown. Both conditions seem to involve both central and peripheral pain mechanisms and inflammation to some degree. However, it remains unknown whether the pain mechanisms are homogenous among patients with said conditions or if different pain phenotypes exist that may respond differently to treatments.
The initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consortium has recognized this. IMMPACT recommends that clinical trials with chronic pain patients assess different domains of the pain experience (psychosocial, pain qualities, sleep, and pain pathways) to examine if pain phenotypes exist and whether different treatment modalities are more effective for certain phenotypes.
Methods: A cross-sectional study examining the difference in pain phenotype and pain mechanisms between patients with Hand-OA, PsA and healthy pain free controls using questionnaire assessments and quantitative sensory testing aiming at investigating pain pathways in the central nervous system. Participants will also have blood drawn to evaluate serological biomarkers for inflammation and joint degeneration.
Aim: To examine the pain phenotypes and assess differences in pressure pain threshold between patients with Hand-OA, PsA and healthy pain free controls.
Patients and controls: Patients with nodal non-erosive Hand-OA or PsA and visual analogue scale for pain (VAS pain) during the last 24hours of 30mm or more.
Controls are healthy age and gender matched subjects with no known chronic pain conditions and maximal pain during last 24 hours under 10mm on a 100mm VAS.
Examination programme: All participants will receive a full medical interview and a physical examination which includes auscultation, blood pressure, heart rate and saturation measurements and BMI calculation. All participants will have blood drawn for later examination for markers of inflammation and degeneration. All participants will go through Quantitative Sensory Testing (QST). QST covers a wide range of different examinations techniques used to assess the functional status of the somatosensory system33. In the present study pressure algometry and cuff algometry will be performed.
Pain phenotyping: Participants will answer a series of questionnaires related to the pain experience to assess: Anxiety and depression (the hospital anxiety and depression scale), pain catastrophizing (the pain catastrophizing scale), pain description (The short form McGill questionnaire and pain detect questionnaire), sleep quality (Pittsburgh sleep quality index) and a widespread pain assessment questionnaire. To assess function and quality of life the Short form 36 and Health assessment questionnaire will be used.
Patients with PsA: Will receive an examination for disease specific tests including: joint tenderness and swelling using the European league against rheumatism (EULAR) 66/68 regiment, dactylitis evaluation using Leeds dactylitis index basic, skin involvement using the psoriasis area and severity index and nail psoriasis via nail psoriasis severity index.
Patients with Hand-OA: Will receive the following disease specific examinations evaluation of tender and swollen joints of the hands and wrists. Grip and pinch strength measurements using a hand-held dynamometer.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | – | –Patients with painful psoriatic arthritis |
| Hand Osteoarthritis | – | –Patients with painful nodal non-erosive hand osteoarthritis |
| Healthy Controls | – | –Patients without a painful condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PsA and Hand-OA patients will be picked from primary and secondary care. Healthy volunteers will be picked from the community.
Key inclusion criteria (11 listed)
- Patients (above 18 years) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)
- Hand-OA of the phenotype: Nodal, Non-erosive.
- Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
- VAS pain during the last 24 hours 30mm or more
- Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment.
Key exclusion criteria (11 listed)
- Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout) *
- Erosive Hand-OA (One or more erosive joints on plain x-ray)
- Isolated Hand-OA of the first metacarpal joint or this joint as the most painful*
- Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
- Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowl disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Between group difference in Pressure pain threshold (PPT)
Time frame: Day One
Difference PPT between groups measured in kPa
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 37712295Vela J, Dreyer L, Petersen KK, Arendt-Nielsen L, Duch KS, Amris K, Kristensen S. Quantitative sensory testing, psychological profiles and clinical pain in patients with psoriatic arthritis and hand osteoarthritis experiencing pain of at least moderate intensity. Eur J Pain. 2024 Feb;28(2):310-321. doi: 10.1002/ejp.2183. Epub 2023 Sep 15.
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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 Arthritis, Psoriatic and Hand Osteoarthritis, run by Aalborg University Hospital at 1 site in Denmark.
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 11 inclusion and 11 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: paused, as of the sponsor's last update on 5 Jan 2021. 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 Denmark. 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?
Results are not available in the source record.
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?
Between group difference in Pressure pain threshold (PPT) (time frame: Day One). 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 NCT03703934, which also lists 1 linked publication.
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 Jan 2021.