Osteoarthritis ThumbTOPSNCT05932628
Thumb Osteoarthritis Prognosis for Supported Self-managment
An observational study of Osteoarthritis Thumb, run by University Hospitals of Derby and Burton NHS Foundation Trust at 4 sites in United Kingdom.
Trial summary
Background Thumb base osteoarthritis (OA) is common in adults 40 years and over. It affects a person's ability to work, be independent and care for others. Sufferers complain of severe pain and difficulty in completing everyday tasks. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- This study will observe participants who receive a supported self management approach for thumb base osteoarthritis but it is not an interventional study.
- How many people
- 150 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 8 Aug 2023to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- Adult, Older adult
Study population: This study will recruit participants seeking care for a painful thumb, with a clinical diagnosis (signs and symptoms) of thumb base OA. Radiographs are not required to diagnose and provide therapy treatment for thumb base OA, clinical assessment alone will be used (NICE guidelines).
Who may be able to join
- Symptomatic thumb base OA, confirmed with at least one of the following clinical signs:
- Hard tissue enlargement of the thumb carpometacarpal joint
- Squaring at the base of the thumb
- Crepitus on movement of the thumb carpometacarpal joint
- Positive adduction provocation test
- Positive extension provocation test
Show all 10Show fewer
- Positive pressure shear test
- Pain on palpation of the dorso-radial aspect of the thumb carpometacarpal joint
- Able to give written informed consent.
- Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions.
Who cannot join
- Currently receiving therapy care for thumb base OA.
- Fractures or significant injury or surgery to the wrist or hand on the included side in the previous 6 months.
- Previous surgery to the basal thumb joint on the included side.
- Red flags i.e., diagnosed rheumatic condition (gout, rheumatoid arthritis), progressive neurological signs, any acutely swollen hand joint, serious illness, or disease.
- Participants of any drug or medical device trial in the last 12 weeks.
- Recent steroid injection in their included basal thumb joint (2 months prior to baseline appointment).
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Pulvertaft Hand Centre
Derby, DE22 3NE
MOSAIC Service, Nottingham City Care
Nottingham, NG7 5HY
Pennine MSK Partnership Ltd
Oldham, OL1 1NL
Kings Mill Hospital, Hand Therapy Service
Sutton in Ashfield, NG17 4JL
About this study
Official title: Outcome and Prognosis of Supported Self-management in Thumb Base Osteoarthritis: A Prospective Cohort Study
Background Thumb base osteoarthritis (OA) is common in adults 40 years and over. It affects a person's ability to work, be independent and care for others. Sufferers complain of severe pain and difficulty in completing everyday tasks. The main treatment for the condition is advice on how a person can manage their condition (self-management), reduce their pain, strengthen their hands with exercises and practical tips on tackling painful tasks, sometimes providing a hand splint for support. The treatment is provided by occupational and physiotherapists. We know that this treatment helps suffers in the short term (up to three months). But the research was done in people with few other health problems and while self-management support helps provide pain relief for most people, there are some people who don't benefit. The aim of this research is to see how pain and other hand problems change over a period of six months after the start of treatment, to understand people's experience of care, and examine why some people improve, and some do not.
Research Plan In patients receiving treatment for thumb base OA at four NHS sites, who are willing to take part, this research will: -
- Record changes in symptoms and quality of life at three and six months from when treatment began in a postal questionnaire/survey.
- Discuss the experience of care and people's beliefs about what makes treatment a success by interviewing a small group of patients.
- Analyse patient characteristics, to see if it is possible to determine how they will respond to treatment.
- Develop recommendations for improving care.
Read the detailed description
Background
Thumb base osteoarthritis occurs in 21-45% of the adult population over 40 and can cause severe pain and difficulty with essential everyday hand use. Guidelines recommend that those seeking care should receive education and exercises (supported self-management), and, if needed, splints. However, these guidelines are based on research reporting outcomes at three months or less, often excluding those with other hand conditions and co-morbidities. In these studies, self-management was found to provide pain relief for about half of study participants, with the remaining individuals not benefiting significantly in terms of pain at three months. Furthermore, there is no research on the patient's experience of care.
The aim of this study is to investigate, using a mixed methods approach the outcomes, prognosis, and experiences of care in patients receiving usual National Health Service (NHS) care which consists of a supported self-management programme, and to generate recommendations for optimising care for thumb base Osteoarthritis (OA). The design will be a prospective longitudinal cohort study linked with a qualitative interview and focus group study. Four NHS sites will recruit 150 people with symptomatic thumb base OA. The primary outcome is the AUSCAN hand pain scale, additionally baseline assessments will be carried out for measures of hand function, quality of life and known musculoskeletal prognostic factors. The study endpoint is six months. Outcome assessments will be conducted by postal/online questionnaire (as applicable) at three and six months. The qualitative and quantitative results from this study will be integrated and presented to a stakeholder group meeting, where participants will be guided to generate recommendations for future care.
Objectives
- To determine the 6-month outcomes (change in pain, hand function, participation in social roles and activities, and quality of life) in a cohort of patients with thumb base OA receiving supported self-management in specialist NHS services. And to estimate the proportion of those who respond after treatment.
- To evaluate patient experiences with care and determine what factors patients and clinicians perceive contribute to outcome (candidate prognostic factors).
- To investigate the association of prognostic factors with pain and function outcomes.
- To integrate qualitative and quantitative findings to generate recommendations for optimising current care.
STUDY DESIGN
This study is a mixed methods convergent parallel design, and is divided into three parts:
- Prospective cohort study in people with symptomatic thumb base OA receiving a supported self-management programme to provide 3- and 6-month outcome data; and record any subsequent stepped care provided according to existing guidelines.
- Qualitative Research: semi-structured interviews will describe the experience of care and explore patient perception of factors related to outcome, and a focus group will explore treating therapist perceptions of factors related to outcome.
- Stakeholder and PPIE meeting to discuss and disseminate the results with patients and clinicians and to generate recommendations for improving care for patients.
- Conditions
- Osteoarthritis Thumb
- Being tested
- This study will observe participants who receive a supported self management approach for thumb base osteoarthritis but it is not an interventional study.
- Keywords
- Education, Exercise, Splint, Prognosis, Experience, Quality of care, Mixed Methods
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study will observe participants who receive a supported self management approach for thumb base osteoarthritis but it is not an interventional study.Other
Participants will receive an occupational or physiotherapist led supported self-management programme, which equates to normal NHS care, having been adopted by the sites involved. This involves education, progressive exercises and hand splints if required. The educational materials used, and a minimum number of appointments will be consistent across the study sites. Additional treatments for coexisting conditions will be provided, additional stepped care for thumb base osteoarthritis will also be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain Subscale
The AUSCAN is a patient-rated, disease-specific, and hand-specific questionnaire with a pain subscale comprising of five items measuring hand pain (0-20), greater scores indicate worse pain.
Measured: 6 months
Secondary outcomes (7)
Osteoarthritis Research Society International (OARSI) responder Criteria
Participants are evaluated as a responder or non-responder to treatment. This is calculated based on a global rating of change (GROC) question with 6 items (on a Likert scale ranging from completely recovered to much worse); and absolute or relative changes in AUSCAN scores for pain and function (Ref Pham 2004).
Measured: 3 & 6 months
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain & Function Subscales
The AUSCAN is a patient-rated, disease-specific, and hand-specific questionnaire comprising of five items measuring hand pain (0-20), one item measuring stiffness (0-4), and nine measuring hand function (0-36). The total score ranges from 0-60 with higher scores indicating more pain, stiffness, or functional limitation.
Measured: 3 & 6 months
Numerical rating scale (NRS) Thumb pain (0-10)
NRS specific to thumb pain severity over the last week, higher scores indicate greater pain severity.
Measured: 3 & 6 months
Thumb Pain Frequency
5 point Likert scale (never- always)
Measured: 3 & 6 months
PSEQ
Pain self efficacy questionnaire
Measured: 3 & 6 months
EQ-5D-5L
Generic health status and quality of life
Measured: 3 & 6 months
PROMIS SF
Social participation and difficulty in daily life
Measured: 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start8 Aug 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Keele University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932628
- Sponsor's protocol ID
- UHDB/2021/042
- Acronym
- TOPS
- Status last verified
- Oct 2024
- First submitted
- 27 Jun 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data is not being uploaded to an external repository. Keele University have a process for data sharing, and all requests would follow their usual process. The CTU can be contacted from the website https://www.keele.ac.uk/ctu/
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Prognosis of Supported Self-management in Thumb Base Osteoarthritis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05932628
- Acronym / sponsor ID
- TOPS / UHDB/2021/042
- Conditions
- Osteoarthritis Thumb
- Keywords
- Education, Exercise, Splint, Prognosis, Experience, Quality of care, Mixed Methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Keele University
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Jul 2023 (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.
Background Thumb base osteoarthritis (OA) is common in adults 40 years and over. It affects a person's ability to work, be independent and care for others. Sufferers complain of severe pain and difficulty in completing everyday tasks. The main treatment for the condition is advice on how a person can manage their condition (self-management), reduce their pain, strengthen their hands with exercises and practical tips on tackling painful tasks, sometimes providing a hand splint for support. The treatment is provided by occupational and physiotherapists. We know that this treatment helps suffers in the short term (up to three months). But the research was done in people with few other health problems and while self-management support helps provide pain relief for most people, there are some people who don't benefit. The aim of this research is to see how pain and other hand problems change over a period of six months after the start of treatment, to understand people's experience of care, and examine why some people improve, and some do not.
Research Plan In patients receiving treatment for thumb base OA at four NHS sites, who are willing to take part, this research will: -
- Record changes in symptoms and quality of life at three and six months from when treatment began in a postal questionnaire/survey.
- Discuss the experience of care and people's beliefs about what makes treatment a success by interviewing a small group of patients.
- Analyse patient characteristics, to see if it is possible to determine how they will respond to treatment.
- Develop recommendations for improving care.
Detailed description
Background
Thumb base osteoarthritis occurs in 21-45% of the adult population over 40 and can cause severe pain and difficulty with essential everyday hand use. Guidelines recommend that those seeking care should receive education and exercises (supported self-management), and, if needed, splints. However, these guidelines are based on research reporting outcomes at three months or less, often excluding those with other hand conditions and co-morbidities. In these studies, self-management was found to provide pain relief for about half of study participants, with the remaining individuals not benefiting significantly in terms of pain at three months. Furthermore, there is no research on the patient's experience of care.
The aim of this study is to investigate, using a mixed methods approach the outcomes, prognosis, and experiences of care in patients receiving usual National Health Service (NHS) care which consists of a supported self-management programme, and to generate recommendations for optimising care for thumb base Osteoarthritis (OA). The design will be a prospective longitudinal cohort study linked with a qualitative interview and focus group study. Four NHS sites will recruit 150 people with symptomatic thumb base OA. The primary outcome is the AUSCAN hand pain scale, additionally baseline assessments will be carried out for measures of hand function, quality of life and known musculoskeletal prognostic factors. The study endpoint is six months. Outcome assessments will be conducted by postal/online questionnaire (as applicable) at three and six months. The qualitative and quantitative results from this study will be integrated and presented to a stakeholder group meeting, where participants will be guided to generate recommendations for future care.
Objectives
- To determine the 6-month outcomes (change in pain, hand function, participation in social roles and activities, and quality of life) in a cohort of patients with thumb base OA receiving supported self-management in specialist NHS services. And to estimate the proportion of those who respond after treatment.
- To evaluate patient experiences with care and determine what factors patients and clinicians perceive contribute to outcome (candidate prognostic factors).
- To investigate the association of prognostic factors with pain and function outcomes.
- To integrate qualitative and quantitative findings to generate recommendations for optimising current care.
STUDY DESIGN
This study is a mixed methods convergent parallel design, and is divided into three parts:
- Prospective cohort study in people with symptomatic thumb base OA receiving a supported self-management programme to provide 3- and 6-month outcome data; and record any subsequent stepped care provided according to existing guidelines.
- Qualitative Research: semi-structured interviews will describe the experience of care and explore patient perception of factors related to outcome, and a focus group will explore treating therapist perceptions of factors related to outcome.
- Stakeholder and PPIE meeting to discuss and disseminate the results with patients and clinicians and to generate recommendations for improving care for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will recruit participants seeking care for a painful thumb, with a clinical diagnosis (signs and symptoms) of thumb base OA. Radiographs are not required to diagnose and provide therapy treatment for thumb base OA, clinical assessment alone will be used (NICE guidelines).
Key inclusion criteria (10 listed)
- Symptomatic thumb base OA, confirmed with at least one of the following clinical signs:
- Able to give written informed consent.
- Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions.
Key exclusion criteria (6 listed)
- Currently receiving therapy care for thumb base OA.
- Fractures or significant injury or surgery to the wrist or hand on the included side in the previous 6 months.
- Previous surgery to the basal thumb joint on the included side.
- Red flags i.e., diagnosed rheumatic condition (gout, rheumatoid arthritis), progressive neurological signs, any acutely swollen hand joint, serious illness, or disease.
- Participants of any drug or medical device trial in the last 12 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study will observe participants who receive a supported self management approach for thumb base osteoarthritis but it is not an interventional study.Participants will receive an occupational or physiotherapist led supported self-management programme, which equates to normal NHS care, having been adopted by the sites involved. This involves education, progressive exercises and hand splints if required. The educational materials used, and a minimum number of appointments will be consistent across the study sites. Additional treatments for coexisting conditions will be provided, additional stepped care for thumb base osteoarthritis will also be recorded. | Other | – |
Primary outcome
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain Subscale
Time frame: 6 months
The AUSCAN is a patient-rated, disease-specific, and hand-specific questionnaire with a pain subscale comprising of five items measuring hand pain (0-20), greater scores indicate worse pain.
7 secondary outcomes
Osteoarthritis Research Society International (OARSI) responder Criteria
Time frame: 3 & 6 months
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain & Function Subscales
Time frame: 3 & 6 months
Numerical rating scale (NRS) Thumb pain (0-10)
Time frame: 3 & 6 months
Thumb Pain Frequency
Time frame: 3 & 6 months
PSEQ
Time frame: 3 & 6 months
EQ-5D-5L
Time frame: 3 & 6 months
PROMIS SF
Time frame: 3 & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- 12 NICE Guidelines: osteoarthritis in the over 16s diagnosis and managementLink provided by the sponsor.
- TOPS study website for participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data is not being uploaded to an external repository. Keele University have a process for data sharing, and all requests would follow their usual process. The CTU can be contacted from the website https://www.keele.ac.uk/ctu/
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Thumb, run by University Hospitals of Derby and Burton NHS Foundation Trust at 4 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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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?
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain Subscale (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 27 Feb 2025.