Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort

NCT ID: NCT05105854

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2029-02-07

Brief Summary

Adults with painful hand osteoarthritis are invited to take part in this observational cohort study. The course of hand pain can vary and is not well understood - some people seem to have short episodes of worsening pain ('flares') and the trend (or 'trajectory') over a longer period of time may be of improvement, staying stable or worsening. The study aims to identify and define different pain trajectories in hand OA, including factors which may predict the future course of pain in the condition.

Due to the Covid-19 pandemic, currently all study related activities are being carried out remotely (online, by post, by phone).

Conditions

Hand Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to give informed consent to participate in the study.
• Aged 18 years or above
• The participant reports a diagnosis of hand osteoarthritis made by a health care professional OR (Optional inclusion, for review after 3 months*) The participant reports a diagnosis of hand osteoarthritis

• Given the Covid-19 pandemic, it is not clear if requiring a health care professional diagnosis will limit participation in the study. If, after 3 months of recruitment, fewer than 24 participants have been recruited, self-reported diagnosis, supported by additional materials available on the study website or by discussion with a study team member by phone will be acceptable. Numbers in each of these two categories will be recorded.
• Two or more painful hand joints: interphalangeal and/or base of thumb
• Hand pain on most days of the last month i.e. ≥15 days in the last month
• Competency of English language that permits written informed consent and independent completion of questionnaires

Exclusion Criteria

The participant may not enter the study if any of the following apply:

• Other cause for hand pain including rheumatoid arthritis, psoriatic arthritis, gout, haemochromatosis or connective tissue disease.
• Current or previous diagnosis of psoriasis
• Any additional condition which is substantially contributing to hand pain or would confound the measurement of hand pain, including but not limited to: chronic widespread pain, active tenosynovitis causing hand pain, active carpal tunnel syndrome, active cervical radiculopathy
• Recent change in treatments

• Within the last four weeks:

Initiation of new analgesic or change in usual dose or route; Use of oral steroids or intraarticular steroid to sites other than the hand

• Within the last three months:

Use of intraarticular steroid to the hand; Initiation of glucosamine, chondroitin, hand exercises or other relevant non- pharmacological therapy for hand pain; Initiation or change in dose, route or formulation of hormonal therapy (such as hormone replacement or contraceptive); Use of intramuscular steroid

• Within the last six months:

Use of immunosuppressive treatment; Hand surgery within the last six months, or planned within the next six months; Use of intra-articular hyaluronan to the hand in the last six months

• Current participant in an interventional research trial that involves blinding of treatment allocation
• Any other significant or uncontrolled disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versus Arthritis

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, , United Kingdom

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Countries

United Kingdom

Related Links

http://www.hopecohort.org.uk

This link will take you to the study website which contains more information about the study as well as information about how to take part.

Other Identifiers

14602

Identifier Type: -

Identifier Source: org_study_id