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

NCT03703934 | Suspended DMC

• 1 other identifier: 210417
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Psoriatic; Hand Osteoarthritis

Keywords

Pain phenotyping; Quantitative sensory testing

Outcome Measures

Primary Outcomes (1)

• Between group difference in Pressure pain threshold (PPT)

  Difference PPT between groups measured in kPa

  Day One

Study Arms (3)

Psoriatic Arthritis

Patients with painful psoriatic arthritis

Hand Osteoarthritis

Patients with painful nodal non-erosive hand osteoarthritis

Healthy Controls

Patients without a painful condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Department of Rheumatology Aalborg Universityhospital North

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 12, 2018
• Study Start: October 20, 2018
• Primary Completion: April 1, 2021
• Study Completion: July 30, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

DK (1)