Methotrexate in Erosive Inflammatory Hand Osteoarthritis
NCT04579848
Erosive Osteoarthritis, Hand Osteoarthritis
Oslo, Norway
View Trial DetailsNCT Number: NCT05105854
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant may not enter the study if any of the following apply:
Initiation of new analgesic or change in usual dose or route; Use of oral steroids or intraarticular steroid to sites other than the hand
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
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
Time frame: 6 months
Average hand pain (daily rating)
Time frame: 6 months
Trajectory Category (as determined by the primary objective), which may include persistent stable, persistent worsening, resolving, fluctuating, presence of flares
Time frame: The previous 7 days and for 7 days after the study visit, up to 6 months
Hand pain (0 to 10 on a numerical rating scale)
Time frame: 6 months, 2 years 5 years
Presence of flare/change in hand pain (yes/no) as self-reported by the participant
Time frame: At time of self reported flare (the previous 7 days and for 7 days after the study visit)
Clinical history (antecedent events, sleep quality and disturbance, analgesic use); Pain measures: to identify a numerical definition (0-10 on NRS) of pain flare in hand OA; Duration of a flare; Morning stiffness (minutes); Clinical examination including Grip Strength; Hand Function (Functional Index for Hand Osteoarthritis (FIHOA) Questionnaire); Brief Pain Inventory Short Form; Global Well-being Visual Analogue Scale (0-100); Hospital Anxiety and Depression Scale (HADS); Anger/Frustration Short Form questionnaire (PROMIS); Features on hand photograph; Acoustic emission from hand movements
Time frame: 6 months
Daily weather recording, derived from a Meteorological Service website (including temperature, pressure, humidity, precipitation, wind speed)
Acoustic emissions from hand movements
University of Oxford
Other
Acronym: HOPE-c
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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