Trial Review

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Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



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Trial registered on ANZCTR


Registration number
ACTRN12614000671662
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
25/06/2014
Date last updated
28/06/2019
Date data sharing statement initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Conservative management of first carpometacarpal (CMC) joint osteoarthritis: a single blinded randomised controlled trial
Scientific title
Clinical outcomes of adults with first carpometacarpal (CMC) joint osteoarthritis treated with either a push brace orthosis, corticosteroid injection, a basic hand therapy program or a combination of interventions
Secondary ID [1] 284821 0
None
Secondary ID [2] 295616 0
Nil known
Universal Trial Number (UTN)
U1111-1217-7818
Trial acronym
CMCOA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the first Carpometacarpal joint (of the thumb) 292207 0
Condition category
Condition code
Musculoskeletal 292541 292541 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 292613 292613 0 0
Occupational therapy
Physical Medicine / Rehabilitation 292614 292614 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group 1: Basic hand therapy program including a standardised exercise program; advice on pain management including thermal modalities; joint protection and activity modification provided in a 15 minute consultation with a qualified occupational therapist AND Push brace orthosis fitted by a qualified occupational therapist.

Intervention Group 2: Basic hand therapy program (as above) AND Ultra-sound guided Corticosteriod injection (1mL of celestone chronodose and 1mL 0.5% marcaine) to the CMC joint (of the thumb) provided by a qualified radiologist

Intervention Group 3: Basic hand therapy program (as above) AND Push brace orthosis (as above) AND Ultra-sound guided Corticosteriod injection (as above)
Intervention code [1] 289614 0
Treatment: Drugs
Intervention code [2] 289615 0
Treatment: Other
Intervention code [3] 289664 0
Rehabilitation
Comparator / control treatment
Control Group 1: Basic hand therapy program including a standardised exercise program; advice on pain management including thermal modalities; joint protection and activity modification provided in a 15 minute one-off consultation with a qualified occupational therapist.
Control group
Active

Outcomes
Primary outcome [1] 292409 0
Pain measured using a 100 point (10 cm) visual analogue scale
Timepoint [1] 292409 0
Baseline (pre-intervention); 3 months; 6 months; 12 months; 24 months
Primary outcome [2] 292410 0
Osteoarthritis Disease specific outcome Measure (AUSCAN Hand Osteoarthritis Index)
Timepoint [2] 292410 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months
Secondary outcome [1] 308883 0
Function using Patient Rated Wrist and Hand Evaluation
Timepoint [1] 308883 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months
Secondary outcome [2] 308884 0
Pinch Strength using a Pinch Gauge
Timepoint [2] 308884 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months
Secondary outcome [3] 308885 0
Global improvement measured using a Global Rating of Change Scale for symptoms and function
Timepoint [3] 308885 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months
Secondary outcome [4] 308886 0
Health rated quality of life measured using the EQ-5D
Timepoint [4] 308886 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months
Secondary outcome [5] 308887 0
Adverse events for the thumb orthosis which could include allergic dermatitis, skin maceration, pressure areas or heat rash. Adverse events for the injection could include allergic reaction, abnormal systemic responses, dizziness, nausea, cognitive dysfunction.
Timepoint [5] 308887 0
Baseline (pre-intervention); 3 months; 6 months; 12 months 24 months

Eligibility
Key inclusion criteria
1- 18 years and over
2- Clinical diagnosis of primary idiopathic 1st CMC joint osteoarthritis
3 - Minimal level of symptoms of either a pain score of at least 30 (out of 100) on VAS or 22 (out of 90) on the AUSCAN NRS 4.1 subscale
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Inflammatory joint conditions including rheumatoid arthritis and gout
2- Significant untreated Dupuytren's Disease resulting in severely impaired function
3- History of previous conservative management of 1st CMC joint arthritis including use of a splint within the last 3 months
4- History of corticosteriod injection or Hyaluronate injection in either of the hands
5- Previous soft tissue injury or fracture of the thumb or wrist joints that has resulted in significant function limitation
6- Pregnancy
7- High medical dependency that may interfere with ability to return for assessments or compliance with interventions

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)
The study patient population will be recruited from the private consulting practices of the orthopaedic surgeons at the Brisbane Hand and Upper Limb Clinic at the Brisbane Private Hospital. Once a participant has consented and completed their pre-treatment assessment, the patient will be randomised and allocated to an intervention group. This will be done by a research assistant who will not be blind to allocation for the duration of the study. They will open an envelope and reveal the allocation to the patient. They will then make referrals to hand therapy for orthosis and/or to the referring surgeon for the injection as required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer generated and concealed in sequentially numbered sealed, opaque envelopes by a person, not otherwise associated with recruitment, to eliminate any risk of randomisation bias. Each envelope will contain a sheet of paper with the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Update
Baseline demographic and clinical data will be reported using descriptive statistics and will be tabulated. Between groups differences in baseline data will be examined using unpaired conventional tests of hypothesis depending on the nature of the data. Between group and within group differences in outcome measures over time will be examined using a priori unpaired and paired conventional tests of hypothesis depending on the nature of the data. Linear mixed effects models will be used to examine the within and between group variability of the four groups. Bonferroni adjustments for multiple comparisons will be made where appropriate to mitigate risk of type-1 error.
The complication rates will be reported in terms of frequency. The frequencies of complications will be compared using statistical analysis such as the Pearson chi-square statistic.


276 participants will be recruited in the study (69 allocated to each group).

Recruitment is anticipated to take approximately 60 weeks based on historical patient presentation rate of this patient group and a 75% recruitment rate into the study.

In calculating our sample size we have allowed for:
1. 30% loss to follow up
2. Historical information from our unit that 25% of patients who are offered conservative management for this condition opt for surgery within 3 months.

This investigation has 95% power to detect a between group mean (SD) difference in the primary outcome pain (VAS) of 17 (3).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/08/2014
Actual
19/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
276
Accrual to date
96
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2655 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 8313 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 289434 0
Charities/Societies/Foundations
Name [1] 289434 0
Brisbane Hand and Upper Limb Research Institute
Country [1] 289434 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brisbane Hand and Upper Limb Research Institute
Address
9/259 Wickham Terrace, Brisbane, QLD 4000
Country
Australia
Secondary sponsor category [1] 288122 0
None
Name [1] 288122 0
None
Address [1] 288122 0
Country [1] 288122 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291192 0
Mater Human Research and Ethics Committee
Ethics committee address [1] 291192 0
Ethics committee country [1] 291192 0
Australia
Date submitted for ethics approval [1] 291192 0
17/06/2014
Approval date [1] 291192 0
03/11/2014
Ethics approval number [1] 291192 0
HREC/14/MHS/40

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2901 2901 0 0
/AnzctrAttachments/366557-CMCOA Participant Information Form v.1.5.pdf (Participant information/consent)
Attachments [2] 2902 2902 0 0
/AnzctrAttachments/366557-PatientPoster CMCOA.pdf (Other)
Attachments [3] 2903 2903 0 0
/AnzctrAttachments/366557-Hand_Therapy-2015-Peters-39-48.pdf (Publication)

Contacts
Principal investigator
Name 49286 0
Prof Mark Ross
Address 49286 0
Brisbane Hand and Upper Limb Research Institute 9/259 Wickham Terrace Brisbane QLD 4000
Country 49286 0
Australia
Phone 49286 0
+ 61 7 3834 7069
Fax 49286 0
Email 49286 0
[email protected]
Contact person for public queries
Name 49287 0
Silvia Manzanero
Address 49287 0
Brisbane Hand and Upper Limb Research Institute 9/259 Wickham Terrace Brisbane QLD 4000
Country 49287 0
Australia
Phone 49287 0
+61 7 3834 7069
Fax 49287 0
Email 49287 0
[email protected]
Contact person for scientific queries
Name 49288 0
Silvia Manzanero
Address 49288 0
Brisbane Hand and Upper Limb Research Institute 9/259 Wickham Terrace Brisbane QLD 4000
Country 49288 0
Australia
Phone 49288 0
+ 61 7 3834 7069
Fax 49288 0
Email 49288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Available to researchers with Ethics-approved projects (must provide protocol and evidence of approval).

Conditions for requesting access:
• -

What individual participant data might be shared?
• Data from participants who have given permission to share their data for research projects.
Names will be removed, dates of birth will be converted to ages and individual identifiers will be removed rendering the data non-identifiable

What types of analyses could be done with individual participant data?
• Available for analysis for any research with Ethics approval.

When can requests for individual participant data be made (start and end dates)?
From:
The start date of IPD availability will be 1/12/2025 with no end-date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• We intend to share the data in med.data.edu.au.
Licencing will be discussed with med.data.

Are there extra considerations when requesting access to individual participant data?
No


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
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of the Push BraceTM orthosis and corticosteroid injection for managing first carpometacarpal joint osteoarthritis: A factorial randomised controlled trial protocol.2015https://dx.doi.org/10.1177/1758998315584835
N.B. These documents automatically identified may not have been verified by the study sponsor.