Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06137404




Registration number
NCT06137404
Ethics application status
Date submitted
29/10/2023
Date registered
18/11/2023
Date last updated
18/11/2023

Titles & IDs
Public title
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Scientific title
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Secondary ID [1] 0 0
WaikatoH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trigger Finger 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Splint

Active comparator: Splint M - Metacarpophalangeal joint blocking splint

Experimental: Splint R - Relative motion extension splint


Other interventions: Splint
Comparison of splints for trigger finger
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Green's classification for trigger finger
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
QuickDASH (Disability of Arm, Shoulder and Hand)
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Trigger finger patient
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diabetes, non-English speaking

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
Waikato Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.
Trial website
https://clinicaltrials.gov/study/NCT06137404
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aarti Parekh, B.Physio
Address 0 0
Waikato Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06137404