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Trial registered on ANZCTR


Registration number
ACTRN12618001639213
Ethics application status
Approved
Date submitted
1/10/2018
Date registered
3/10/2018
Date last updated
19/11/2020
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Splinting for thumb base osteoarthritis: a feasibility study
Scientific title
Splinting for thumb carpometacarpal osteoarthritis: a feasibility randomised controlled trial
Secondary ID [1] 296218 0
Nil
Universal Trial Number (UTN)
U1111-1221-4460
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thumb carpometacarpal osteoarthritis 309855 0
Condition category
Condition code
Musculoskeletal 308647 308647 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomized to the intervention group will be fitted with a soft neoprene hand-based splint (Procool T/R Splint Bound, @Therapy) and instructed to wear the splint 20 hours out of 24 for a total duration of 4 weeks, in addition to standardised usual care. An explanation of the rationale and wearing schedule for the splint will be given. A simple behavioural intervention will accompany the splint prescription, comprising dedicated time for skill acquisition and practice within the treatment session for donning and doffing the splint; providing feedback and encouragement; and fostering self-efficacy through problem solving to incorporate the splint in everyday life. Minor modifications may be made to the splint (shorten or alter shape of the thumb exit space by cutting; alter length of strap through web space or wrist using NRX Strap, @Therapy) for optimal fitting while maintaining splint aesthetic. Two splints will be issued – one to wash, one to wear. Splint intervention procedure will comprise a one-off face-to-face consult in a health setting in two centres (School of Physiotherapy, Dunedin, and Southland Hospital, Invercargill), anticipated to take 20 minutes per participant.
A registered physiotherapist and hand therapist with 17 years clinical experience (Principal Investigator) will implement the intervention. If participants in either group require any assistance during the 4-week treatment period, they may contact the research administrator for the treating therapist to make an arranged call to the participant. If any issue is unable to be resolved by telephone consult, then a follow up treatment session will be arranged.
Measures to optimize adherence to the intervention include: ensuring the splint is comfortable, well fitted and aesthetically acceptable; advising how to successfully adapt activities without compromising the splint regime; establishing a trusting relationship by providing education and rationale for treatments; catering for different learning styles; and implementing simple behavioural intervention. Actual adherence will be measured by a daily patient log to record splint wearing time. The clinical research administrator will telephone or text reminders on a weekly basis to remind the participant to complete the daily log.
Quality and consistency of implementation of the intervention will be monitored by a senior co-investigator using a tailored quality audit tool.
Intervention code [1] 312548 0
Treatment: Devices
Comparator / control treatment
Both the intervention and control group will receive standardized usual care based on a two-sided A4 size printed information designed specifically for this study: education and rationale regarding osteoarthritis at the thumb CMC joint and joint care principles, simple hand exercises to perform three times weekly (active thumb opposition, active thumb palmar abduction), advice to increase general activity levels (walking or pool), and continue with usual physician care. The same behavioural approach will be taken as for the splint intervention. Standardised usual care treatment will comprise a one-off face-to-face consult in a health setting in two centres (School of Physiotherapy, Dunedin, and Southland Hospital, Invercargill), anticipated to take 25 minutes per participant.
A registered physiotherapist and hand therapist with 17 years clinical experience (Principal Investigator) will implement the standardised usual care.
If participants in either group require any assistance during the 4-week treatment period, they may contact the research administrator for the treating therapist to make an arranged call to the participant. If any issue is unable to be resolved by telephone consult, then a follow up treatment session will be arranged.
Measures to optimize adherence to the standardized usual care include: establishing a trusting relationship by providing education and rationale for treatments; catering for different learning styles; and implementing simple behavioural intervention. Actual adherence will be measured by a daily patient log to record uptake of standardized usual care in both the intervention and the control group. The clinical research administrator will telephone or text reminders on a weekly basis to remind the participant to complete the daily log.
Quality and consistency of implementation of the standardized usual care will be monitored by a senior co-investigator using a tailored quality audit tool.
Control group
Active

Outcomes
Primary outcome [1] 307605 0
Feasibility of study recruitment and retention, as assessed against a-priori feasibility criteria (recruitment of 30 participants in 4 month period, and retention >85% at 6 months) - composite primary outcome.
Timepoint [1] 307605 0
6 months post-commencement of intervention
Primary outcome [2] 307606 0
Feasibility of intervention, as assessed against a-priori feasibility criteria (adherence to intervention greater than or equal to 90% of that prescribed as recorded in daily log; no major adverse events; less than or equal to 10%. minor adverse events; auditor satisfied treatment delivery is consistent and unbiased, as evaluated using quality audit tool; uptake of standardised usual care comparable between groups as recorded in daily log and exit interview) - composite primary outcome.
Timepoint [2] 307606 0
4 weeks and 6 months (primary timepoint) post-commencement of intervention
Primary outcome [3] 307607 0
Feasibility of assessments, as assessed against a-priori feasibility criteria (acceptable to greater than or equal to 90% participants; auditor satisfied assessments are consistent, as evaluated using quality audit too) - composite primary outcome
Timepoint [3] 307607 0
4 weeks and 6 months (primary timepoint) post-commencement of intervention
Secondary outcome [1] 352411 0
Pain at base of thumb on average in past week (Numeric Rating Scale, 0-10)
Timepoint [1] 352411 0
4 weeks and 6 months post-commencement of intervention
Secondary outcome [2] 352412 0
Quick Disability of the Arm, Hand and Shoulder (QuickDASH)
Timepoint [2] 352412 0
4 weeks and 6 months post-commencement of intervention
Secondary outcome [3] 352413 0
Patient-reported health status (EQ5D)
Timepoint [3] 352413 0
4 weeks and 6 months post-commencement of intervention

Eligibility
Key inclusion criteria
• English-speaking adults with thumb carpometacarpal joint osteoarthritis
• Aged 40+ years
• Answer “yes” to the question, “Have you experienced aching, discomfort, pain and/or stiffness in or around the joint at the base of either thumb on most days for at least 1 month (15 or more days of the month) during the past year?” and have no other specific diagnosis.
• Minimum severity pain VAS 4/10
• Minimum score FIHOA 6/30
• Tenderness on palpation of the trapeziometacarpal joint
• Positive grind test OR traction-shift test OR observable “step-off” sign.
• Give written informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Thumb non-symptomatic for the past month
• Previous surgery of the symptomatic joint
• Steroid injection in the past 6 months
• Previous splint intervention prescribed by health professional
• Concurrent rheumatoid arthritis or any other significant inflammatory or autoimmune conditions affecting the hand such as scleroderma, systemic lupus erythematosus and psoriatic arthritis, or another kind of chronic pain syndrome or metabolic disorder, such as fibromyalgia, diabetic neuropathy, or gout.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified by hand dominance. The randomisation schedule will be prepared by the clinical research administrator. Specific information about the block randomization will be provided in a separate document with restricted access, to avoid undermining randomisation by facilitating deciphering of the allocation sequence.
The block size will be concealed until the primary endpoint will be analysed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pragmatic, assessor-blinded and partial participant blinded parallel-group feasibility RCT
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive analysis of findings of feasibility outcomes and appraisal against feasibility criteria. Participant characteristic variables will be presented and the baseline comparability of the two groups assessed. Descriptive statistics will be presented for each group with the mean value (standard deviation, 95% confidence interval) for outcomes at each time point.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
19/04/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
15/08/2019
Date of last data collection
Anticipated
28/02/2020
Actual
5/03/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 20884 0
New Zealand
State/province [1] 20884 0
Otago and Southland

Funding & Sponsors
Funding source category [1] 300815 0
Charities/Societies/Foundations
Name [1] 300815 0
Otago Medical Research Foundation Jack Thomson Arthritis Fund
Country [1] 300815 0
New Zealand
Primary sponsor type
Individual
Name
Miranda Buhler
Address
University of Otago School of Physiotherapy
PO Box 56, Dunedin 9054, New Zealand
Country
New Zealand
Secondary sponsor category [1] 300361 0
Individual
Name [1] 300361 0
Dr Catherine M. Chapple
Address [1] 300361 0
University of Otago School of Physiotherapy
PO Box 56, Dunedin 9054, New Zealand
Country [1] 300361 0
New Zealand
Secondary sponsor category [2] 300364 0
Individual
Name [2] 300364 0
Associate Professor Simon Stebbings
Address [2] 300364 0
University of Otago Dunedin School of Medicine,
PO Box 56, Dunedin 9054, New Zealand
Country [2] 300364 0
New Zealand
Secondary sponsor category [3] 300365 0
Individual
Name [3] 300365 0
Professor G. David Baxter
Address [3] 300365 0
University of Otago School of Physiotherapy
PO Box 56, Dunedin 9054, New Zealand
Country [3] 300365 0
New Zealand
Other collaborator category [1] 280372 0
Individual
Name [1] 280372 0
Associate Professor David Gwynne-Jones
Address [1] 280372 0
University of Otago Dunedin School of Medicine, Dunedin, New Zealand
PO Box 56, Dunedin 9054, New Zealand
Country [1] 280372 0
New Zealand
Other collaborator category [2] 280373 0
Individual
Name [2] 280373 0
Professor Jo Adams
Address [2] 280373 0
Southampton University School of Health Sciences,
University Road, Southampton SO17 1BJ, United Kingdom
Country [2] 280373 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301584 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 301584 0
Ethics committee country [1] 301584 0
New Zealand
Date submitted for ethics approval [1] 301584 0
18/12/2018
Approval date [1] 301584 0
14/03/2019
Ethics approval number [1] 301584 0
18/NTB/240

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87470 0
Ms Miranda Buhler
Address 87470 0
University of Otago School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 87470 0
New Zealand
Phone 87470 0
64 3 479 7460
Fax 87470 0
64 3 479 8414
Email 87470 0
Miranda.Buhler@postgrad.otago.ac.nz
Contact person for public queries
Name 87471 0
Miranda Buhler
Address 87471 0
University of Otago School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 87471 0
New Zealand
Phone 87471 0
64 3 479 7460
Fax 87471 0
64 3 479 8414
Email 87471 0
Miranda.Buhler@postgrad.otago.ac.nz
Contact person for scientific queries
Name 87472 0
Miranda Buhler
Address 87472 0
University of Otago School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 87472 0
New Zealand
Phone 87472 0
64 3 479 7460
Fax 87472 0
64 3 479 8414
Email 87472 0
Miranda.Buhler@postgrad.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not yet determined what data will be shared, when, where and how


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.