Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001038785p
Ethics application status
Submitted, not yet approved
Date submitted
16/07/2022
Date registered
25/07/2022
Date last updated
25/07/2022
Date data sharing statement initially provided
25/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Carpal Tunnel Syndrome project: A prospective cohort study to determine the association between risk factors and clinical features of Carpal Tunnel Syndrome and its diagnosis.
Scientific title
Carpal Tunnel Syndrome project: A prospective cohort study to determine the association between risk factors and clinical features of Carpal Tunnel Syndrome and its electrophysiological diagnosis.
Secondary ID [1] 307585 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Syndrome 327032 0
Condition category
Condition code
Neurological 324206 324206 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This proposal involves prospective data collection from patients undergoing nerve conduction studies at the Lyell McEwin Hospital “Carpal Tunnel Syndrome clinic” to determine the clinical features and risk factors most associated with a diagnosis of carpal tunnel syndrome and response to treatment.

This involves prospective data collection using a standardised questionnaire administered both before and after nerve conduction studies are performed.

Information collected using the standardised questionnaire includes clinical symptoms and signs (such as abnormal sensation in the first 3 fingers) , medical risk factors (such as history of diabetes mellitus or thyroid disease) and pain score with the Visual Analog Scale.

Prospective data collection with a standardised questionnaire will take 5 minutes and folllow up phone calls will last between 2-3 minutes.

A prospective analysis of nerve conduction testing results will be performed to determine the likelihood of each factor contributing to the diagnosis of Carpal Tunnel Syndrome (CTS), as well as the severity of discomfort experienced during nerve conduction studies.

A follow up phone call will be performed at 6 and 12 months post-nerve conduction testing to determine the association between pain thresholds and benefit from surgery.
Intervention code [1] 324045 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332032 0
Participant clinical features and risk factors associated with high positive likelihood ratio for diagnosis of Carpal Tunnel Syndrome on nerve conduction testing as assessed by study-specific questionnaire
Timepoint [1] 332032 0
At time of nerve conduction testing
Secondary outcome [1] 411948 0
Severity of nerve conduction testing related pain as measured by the Visual Analog Scale
Timepoint [1] 411948 0
During initial nerve conduction testing, as well as 6 months and 12 months post-nerve conduction testing

Eligibility
Key inclusion criteria
1. Patients who are over 18 years of age
2. Patients presenting to LMH Carpal Tunnel Syndrome clinic for nerve conduction testing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication to nerve conduction testing e.g. skin breakdown

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1) The diagnostic performance of each variable (including risk factor and clinical feature) will be analyzed with descriptive statistics and diagnostic performance indicators, such as sensitivity and specificity.
2) When calculating these parameters, the presence of a particular feature (such as tingling in the first three digits) in the setting of a given diagnosis (such as carpal tunnel syndrome) will be considered a true positive result.
3) Likelihood ratios and associated confidence interval calculations will be performed using a bootstrapping method similar to that which has been described previously (with 10,000 bootstraps)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22843 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 38141 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 311856 0
Hospital
Name [1] 311856 0
Lyell McEwin Hospital
Country [1] 311856 0
Australia
Primary sponsor type
Hospital
Name
Lyell McEwin Hospital
Address
Haydown Road
Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 313329 0
Individual
Name [1] 313329 0
Dr Rudy Goh
Address [1] 313329 0
Neurology Department
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112
Country [1] 313329 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311295 0
CALHN HREC
Ethics committee address [1] 311295 0
Royal Adelaide Hospital
1 Port Road
Adelaide SA 5000
Ethics committee country [1] 311295 0
Australia
Date submitted for ethics approval [1] 311295 0
15/07/2022
Approval date [1] 311295 0
Ethics approval number [1] 311295 0

Summary
Brief summary
Carpal Tunnel Syndrome (CTS) is a disabling condition and treatments such as wrist bracing and carpal tunnel release surgery can improve patient symptoms and functional outcomes.

Nerve conduction testing has been proven to be a good diagnostic tool (both sensitive and specific) for the diagnosis of carpal tunnel syndrome.

The association between a combination of extended risk factors and clinical features of carpal tunnel syndrome and its diagnosis has never been estimated via likelihood ratios.

The association between pain experienced during nerve conduction testing and pain experienced from carpal tunnel syndrome has also never been established in the past.

We aim to prove that:
1. There are multiple risk factors and clinical features associated with high positive likelihood ratio for the diagnosis of carpal tunnel syndrome
2. Pain experienced during nerve conduction testing is more severe when pain related to carpal tunnel syndrome itself is more severe.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120606 0
Dr Rudy Goh
Address 120606 0
Neurology Department
Lyell McEwin Hospital
1 Haydown Road
Elizabeth Vale SA 5112
Country 120606 0
Australia
Phone 120606 0
+61 8 8182 9966
Fax 120606 0
Email 120606 0
rudy.goh@sa.gov.au
Contact person for public queries
Name 120607 0
Dr Rudy Goh
Address 120607 0
Neurology Department
Lyell McEwin Hospital
1 Haydown Road
Elizabeth Vale SA 5112
Country 120607 0
Australia
Phone 120607 0
+61 8 8182 9966
Fax 120607 0
Email 120607 0
rudy.goh@sa.gov.au
Contact person for scientific queries
Name 120608 0
Dr Rudy Goh
Address 120608 0
Neurology Department
Lyell McEwin Hospital
1 Haydown Road
Elizabeth Vale SA 5112
Country 120608 0
Australia
Phone 120608 0
+61 8 8182 9966
Fax 120608 0
Email 120608 0
rudy.goh@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.