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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703934
Recruitment Status : Suspended (COVID-19)
First Posted : October 12, 2018
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Jonathan Vela, Aalborg University Hospital

Brief 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 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.


Condition or disease
Arthritis, Psoriatic Hand Osteoarthritis

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Central Pain Mechanisms in Patients With Hand-Osteoarthritis, Psoriatic Arthritis and Healthy Controls
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Group/Cohort
Psoriatic Arthritis
Patients with painful psoriatic arthritis
Hand Osteoarthritis
Patients with painful nodal non-erosive hand osteoarthritis
Healthy Controls
Patients without a painful condition



Primary Outcome Measures :
  1. Between group difference in Pressure pain threshold (PPT) [ Time Frame: Day One ]
    Difference PPT between groups measured in kPa



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703934


Locations
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Denmark
Department of Rheumatology Aalborg Universityhospital North
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Aalborg University

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Responsible Party: Jonathan Vela, Medical Doctor, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03703934    
Other Study ID Numbers: 210417
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Vela, Aalborg University Hospital:
Pain phenotyping
Quantitative sensory testing
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases