Clinical trial NCT05932628: Thumb Osteoarthritis Prognosis for Supported Self-managment
Official title: Outcome and Prognosis of Supported Self-management in Thumb Base Osteoarthritis: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis Thumb
Keywords: Education
Exercise
Splint
Prognosis
Experience
Quality of care
Mixed Methods
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Keele University
First posted: 2023-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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: -

1. Record changes in symptoms and quality of life at three and six months from when treatment began in a postal questionnaire/survey.
2. Discuss the experience of care and people's beliefs about what makes treatment a success by interviewing a small group of patients.
3. Analyse patient characteristics, to see if it is possible to determine how they will respond to treatment.
4. 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

1. 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.
2. To evaluate patient experiences with care and determine what factors patients and clinicians perceive contribute to outcome (candidate prognostic factors).
3. To investigate the association of prognostic factors with pain and function outcomes.
4. 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:

1. 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.
2. 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.
3. Stakeholder and PPIE meeting to discuss and disseminate the results with patients and clinicians and to generate recommendations for improving care for patients.

Eligibility criteria: 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).

Primary outcomes:
measure: Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain Subscale
timeFrame: 6 months
Secondary outcomes:
measure: Osteoarthritis Research Society International (OARSI) responder Criteria
timeFrame: 3 & 6 months
measure: Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain & Function Subscales
timeFrame: 3 & 6 months
measure: Numerical rating scale (NRS) Thumb pain (0-10)
timeFrame: 3 & 6 months
measure: Thumb Pain Frequency
timeFrame: 3 & 6 months
measure: PSEQ
timeFrame: 3 & 6 months
measure: EQ-5D-5L
timeFrame: 3 & 6 months
measure: PROMIS SF
timeFrame: 3 & 6 months
Other outcomes:
measure: Prognostic factor analysis
timeFrame: 6 months
measure: The Osteoarthritis Quality Indicator (OA-QI)
timeFrame: 3 & 6 months
measure: Qualitative data
timeFrame: 3-6 months
Locations:
city: Derby
country: United Kingdom
facility: Pulvertaft Hand Centre
city: Nottingham
country: United Kingdom
facility: MOSAIC Service, Nottingham City Care
city: Oldham
country: United Kingdom
facility: Pennine MSK Partnership Ltd
city: Sutton In Ashfield
country: United Kingdom
facility: Kings Mill Hospital, Hand Therapy Service
Study officials:
References: