Hand OsteoarthritisHOPE-cNCT05105854
Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort
An observational study of Hand Osteoarthritis, run by University of Oxford at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Jul 2021to 7 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with painful hand osteoarthritis
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, W6 8RF
Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7HE
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and define different pain trajectories in hand OA.
Average hand pain (daily rating)
Measured: 6 months
Secondary outcomes (5)
To identify predictors of pain trajectories in hand OA.
Trajectory Category (as determined by the primary objective), which may include persistent stable, persistent worsening, resolving, fluctuating, presence of flares
Measured: 6 months
To test whether there is an association between changes in sex hormone levels and hand pain severity over time within an individual
Hand pain (0 to 10 on a numerical rating scale)
Measured: The previous 7 days and for 7 days after the study visit, up to 6 months
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
Presence of flare/change in hand pain (yes/no) as self-reported by the participant
Measured: 6 months, 2 years 5 years
To characterise features of a flare in hand OA
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
Measured: At time of self reported flare (the previous 7 days and for 7 days after the study visit)
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
Daily weather recording, derived from a Meteorological Service website (including temperature, pressure, humidity, precipitation, wind speed)
Acoustic emissions from hand movements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start7 Jul 2021
- Primary completion7 Feb 2029 (estimated)
- Study completion7 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105854
- Sponsor's protocol ID
- 14602
- Acronym
- HOPE-c
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No data sharing policy established as yet. Potential collaborators may contact the Chief Investigator relating to bone fide research proposals.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Osteoarthritis: Investigating Pain Trajectories and Association With Biomarkers Including Estrogen Cohort
- ClinicalTrials.gov ID
- NCT05105854
- Acronym / sponsor ID
- HOPE-c / 14602
- Conditions
- Hand Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Versus Arthritis
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Feb 2029 (estimated)
- Study completion
- 7 Feb 2029 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with painful hand osteoarthritis
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- 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
- Initiation of new analgesic or change in usual dose or route; Use of oral steroids or intraarticular steroid to sites other than the hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify and define different pain trajectories in hand OA.
Time frame: 6 months
Average hand pain (daily rating)
5 secondary outcomes
To identify predictors of pain trajectories in hand OA.
Time frame: 6 months
To test whether there is an association between changes in sex hormone levels and hand pain severity over time within an individual
Time frame: The previous 7 days and for 7 days after the study visit, up to 6 months
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
Time frame: 6 months, 2 years 5 years
To characterise features of a flare in hand OA
Time frame: At time of self reported flare (the previous 7 days and for 7 days after the study visit)
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
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. No data sharing policy established as yet. Potential collaborators may contact the Chief Investigator relating to bone fide research proposals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Osteoarthritis, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify and define different pain trajectories in hand OA. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.