NCT05105854进行中（未招募）不适用
Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To identify and define different pain trajectories in hand OA.
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To identify and define different pain trajectories in hand OA.
时间窗: 6 months
Average hand pain (daily rating)
次要结局
- To identify predictors of pain trajectories in hand OA.(6 months)
- To characterise features of a flare in hand OA(At time of self reported flare (the previous 7 days and for 7 days after the study visit))
- 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(6 months, 2 years 5 years)
- To test whether there is an association between changes in sex hormone levels and hand pain severity over time within an individual(The previous 7 days and for 7 days after the study visit, up to 6 months)
- 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(6 months)
研究者
研究点 (2)
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