- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05932628
Thumb Osteoarthritis Prognosis for Supported Self-managment (TOPS)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Victoria Jansen, MA
- Phone Number: 44 1332 786985
- Email: victoria.jansen@nhs.net
Study Contact Backup
- Name: Emma Marshall
- Phone Number: 44 1782 733909
- Email: E.J.M.Marshall@keele.ac.uk
Study Locations
-
-
-
Derby, United Kingdom, DE22 3NE
- Recruiting
- Pulvertaft Hand Centre
-
Contact:
- Chloe Kirk, MSc
- Email: chloe.kirk1@nhs.net
-
Contact:
- Anna Selby, PhD
- Email: anna.selby@nhs.net
-
Nottingham, United Kingdom, NG7 5HY
- Recruiting
- MOSAIC Service, Nottingham City Care
-
Contact:
- Rachael Bamford, MSc, BSc, AHT
- Email: rachaelbamford@nhs.net
-
Oldham, United Kingdom, OL1 1NL
- Recruiting
- Pennine MSK Partnership Ltd
-
Contact:
- Charlotte Critchley, BSc
- Email: charlotte.critchley2@nhs.net
-
Contact:
- Jill Firth, RGN PhD
- Email: jill.firth@nhs.net
-
Sutton In Ashfield, United Kingdom, NG17 4JL
- Recruiting
- Kings Mill Hospital, Hand Therapy Service
-
Contact:
- Cheryl Flint, Dip COT
- Email: cheryl.flint@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thumb Pain Frequency
Time Frame: 3 & 6 months
|
5 point Likert scale (never- always)
|
3 & 6 months
|
PSEQ
Time Frame: 3 & 6 months
|
Pain self efficacy questionnaire
|
3 & 6 months
|
EQ-5D-5L
Time Frame: 3 & 6 months
|
Generic health status and quality of life
|
3 & 6 months
|
PROMIS SF
Time Frame: 3 & 6 months
|
Social participation and difficulty in daily life
|
3 & 6 months
|
Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain & Function Subscales
Time Frame: 3 & 6 months
|
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.
|
3 & 6 months
|
Numerical rating scale (NRS) Thumb pain (0-10)
Time Frame: 3 & 6 months
|
NRS specific to thumb pain severity over the last week, higher scores indicate greater pain severity.
|
3 & 6 months
|
Osteoarthritis Research Society International (OARSI) responder Criteria
Time Frame: 3 & 6 months
|
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).
|
3 & 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prognostic factor analysis
Time Frame: 6 months
|
Candidate prognostic factors for response to conservative management will be collected at baseline only.
These factors have been identified from a systematic review of the prognosis for pain and function in hand and thumb base OA (61).
The prognostic factors fall into the following categories clinical signs, general health, psychological factors, and perceived symptom severity.
|
6 months
|
Qualitative data
Time Frame: 3-6 months
|
Topic guides have been created to explore the expereince of receiving care and on participant and therapist perceived prognostic factors.
|
3-6 months
|
The Osteoarthritis Quality Indicator (OA-QI)
Time Frame: 3 & 6 months
|
The OA-QI questionnaire will be used to assess patient-perceived quality of care.
|
3 & 6 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHDB/2021/042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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