Thumb Osteoarthritis Prognosis for Supported Self-managment

NCT05932628 | Active Not Recruiting

• 1 other identifier: UHDB/2021/042
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

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

Conditions

Osteoarthritis Thumb

Keywords

Education; Exercise; Splint; Prognosis; Experience; Quality of care; Mixed Methods

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Osteoarthritis Research Society International (OARSI) responder Criteria

  3 & 6 months

• Australian Canadian Osteoarthritis Hand Index (AUSCAN) Hand Pain & Function Subscales

  3 & 6 months

• Numerical rating scale (NRS) Thumb pain (0-10)

  3 & 6 months

• Thumb Pain Frequency

  3 & 6 months

• PSEQ

  3 & 6 months

Other Outcomes (3)

• Prognostic factor analysis

  6 months

• The Osteoarthritis Quality Indicator (OA-QI)

  3 & 6 months

• Qualitative data

  3-6 months

Interventions

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.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• Keele University: collaborator

Study Sites (4)

Pulvertaft Hand Centre

Derby, DE22 3NE, United Kingdom

Location

MOSAIC Service, Nottingham City Care

Nottingham, NG7 5HY, United Kingdom

Location

Pennine MSK Partnership Ltd

Oldham, OL1 1NL, United Kingdom

Location

Kings Mill Hospital, Hand Therapy Service

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Related Links

• 12 NICE Guidelines: osteoarthritis in the over 16s diagnosis and management
• TOPS study website for participants

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: August 8, 2023
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-10

Locations

GB (4)