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Trial registered on ANZCTR


Registration number
ACTRN12619001063101
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
31/07/2019
Date last updated
31/07/2019
Date data sharing statement initially provided
31/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of caloric vestibular stimulation on pain levels in phantom limb sensations
Scientific title
The effect of caloric vestibular stimulation on pain levels in phantom limb sensations
Secondary ID [1] 298232 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phantom limb pain 312831 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311329 311329 0 0
Other physical medicine / rehabilitation
Neurological 312152 312152 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the intervention group, ice cold water will be delivered via a plastic cannula to the external ear canal of the right ear, for 3 minutes. Water will be delivered continuously by gravity feed and under direct visual observation. After a 5 minute interval, this will be repeated for the contralateral (left) ear. Timing will be monitored by a digital stopwatch. The procedure will be performed by a medical officer. The intervention will be delivered in a single session at a rehabilitation facility.
Intervention code [1] 314474 0
Treatment: Other
Comparator / control treatment
For the first comparator group, ice cold water will be delivered via a plastic cannula to the external ear canal of the right ear, for 30 seconds. Water will be delivered continuously by gravity feed and under direct visual observation. After a 5 minute interval, this will be repeated for the contralateral (left) ear. Timing will be monitored by a digital stopwatch. The procedure will be performed by a medical officer. The intervention will be delivered in a single session at a rehabilitation facility.

For the second comparator group, ice cold water will be delivered via a plastic cannula to the pinna of the right ear, for 30 seconds. Water will be delivered continuously by gravity feed and under direct visual observation. After a 5 minute interval, this will be repeated for the contralateral (left) ear. Timing will be monitored by a digital stopwatch. The procedure will be performed by a medical officer. The intervention will be delivered in a single session at a rehabilitation facility.
Control group
Active

Outcomes
Primary outcome [1] 320577 0
Pain scored on visual analog scale
Timepoint [1] 320577 0
1 hour, 6 hours, 24 hours (primary timepoint), 3 days, 7 days, post-procedure
Secondary outcome [1] 372094 0
Phantom limb experience (normal/natural, deformed or painful) using a study-specific questionnaire
Timepoint [1] 372094 0
1 hour, 6 hours, 24 hours, 3 days, 7 days, post-procedure
Secondary outcome [2] 372095 0
Size of phantom hand/foot (normal, enlarged or shrunken) using a study-specific questionnaire
Timepoint [2] 372095 0
1 hour, 6 hours, 24 hours, 3 days, 7 days, post-procedure
Secondary outcome [3] 372096 0
Length of phantom hand/foot (normal, longer or shorter) using a study-specific questionnaire
Timepoint [3] 372096 0
1 hour, 6 hours, 24 hours, 3 days, 7 days, post-procedure

Eligibility
Key inclusion criteria
Amputees (upper and/or lower limb, unilateral or bilateral, due to any cause
Painful phantom limb(s)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment
Difficulties with speech or communication
Ongoing or history of ear perforation
Active otitis externa or otitis media

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Regression methods will be used to determine the influence of intervention/comparator (indicator variable) on pain score at the time endpoints.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
7/01/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14121 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 26922 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 302770 0
Hospital
Name [1] 302770 0
Department of Rehabilitation Medicine - Hampstead Rehabilitation Centre
Country [1] 302770 0
Australia
Primary sponsor type
Individual
Name
Minh-Son To
Address
Flinders Medical Centre
Flinders Dr
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 303163 0
None
Name [1] 303163 0
Address [1] 303163 0
Country [1] 303163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303367 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 303367 0
Ethics committee country [1] 303367 0
Australia
Date submitted for ethics approval [1] 303367 0
Approval date [1] 303367 0
28/02/2019
Ethics approval number [1] 303367 0
R20180813

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

Contacts
Principal investigator
Name 93426 0
Dr Minh-Son To
Address 93426 0
Flinders Medical Centre
Flinders Dr
Bedford Park, SA 5042
Country 93426 0
Australia
Phone 93426 0
+61 8 82045511
Fax 93426 0
Email 93426 0
minh-son.to@sa.gov.au
Contact person for public queries
Name 93427 0
Minh-Son To
Address 93427 0
Flinders Medical Centre
Flinders Dr
Bedford Park, SA 5042
Country 93427 0
Australia
Phone 93427 0
+61 8 82045511
Fax 93427 0
Email 93427 0
minh-son.to@sa.gov.au
Contact person for scientific queries
Name 93428 0
Minh-Son To
Address 93428 0
Flinders Medical Centre
Flinders Dr
Bedford Park, SA 5042
Country 93428 0
Australia
Phone 93428 0
+61 8 82045511
Fax 93428 0
Email 93428 0
minh-son.to@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient demographics and pain scores pre-/post-procedure
When will data be available (start and end dates)?
Following trial completion (estimated 2021), available for 5 years after publication
Available to whom?
On request to Principal Investigator on case by case at the discretion of the Principal Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By email contact with Principal Investigator (minh-son.to@sa.gov.au)


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.