Clinical trial NCT05105854: Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort
Official title: Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hand Osteoarthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Versus Arthritis
First posted: 2021-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with painful hand osteoarthritis

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).


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

Primary outcomes:
measure: To identify and define different pain trajectories in hand OA.
timeFrame: 6 months
Secondary outcomes:
measure: To identify predictors of pain trajectories in hand OA.
timeFrame: 6 months
measure: To test whether there is an association between changes in sex hormone levels and hand pain severity over time within an individual
timeFrame: The previous 7 days and for 7 days after the study visit, up to 6 months
measure: To identify whether pre-defined variables are: a) Baseline predictors of flare/change during the study b) Associated with the presence of flare/change in hand symptoms
timeFrame: 6 months, 2 years 5 years
measure: To characterise features of a flare in hand OA
timeFrame: At time of self reported flare (the previous 7 days and for 7 days after the study visit)
measure: To assess the following optional features: a) Use of local daily weather recordings and study its association with daily hand pain rating b) Identification of any acoustic emissions that are associated with features of hand OA
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital, Imperial College Healthcare NHS Trust
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
Study officials:
References: