Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls

January 2, 2021 updated by: Jonathan Vela, Aalborg University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Rheumatology Aalborg Universityhospital North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PsA and Hand-OA patients will be picked from primary and secondary care. Healthy volunteers will be picked from the community.

Description

Inclusion criteria Hand-OA

  • 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.

Inclusion criteria PsA

  • Patients (over 18 years) with PsA according to the Clarification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
  • 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.

Inclusion criteria healthy controls

  • Men and women age over18 years
  • Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

Exclusion Criteria:

  • 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Between group difference in Pressure pain threshold (PPT)
Time Frame: Day One
Difference PPT between groups measured in kPa
Day One

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 210417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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