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Trial registered on ANZCTR


Registration number
ACTRN12622000661774
Ethics application status
Approved
Date submitted
11/04/2021
Date registered
5/05/2022
Date last updated
5/05/2022
Date data sharing statement initially provided
5/05/2022
Date results information initially provided
5/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Caloric Vestibular Stimulation in the Treatment of Persistent Pain
Scientific title
Bedside Neuromodulation of Persistent Pain and Allodynia with Caloric Vestibular Stimulation: An Effectiveness Trial
Secondary ID [1] 303202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent pain 320365 0
Allodynia 320366 0
Complex regional pain syndrome 320367 0
Non-specific persistent pain 320368 0
Phantom limb pain 320370 0
Spinal cord injury pain 320371 0
Condition category
Condition code
Neurological 318269 318269 0 0
Other neurological disorders
Mental Health 323428 323428 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caloric Vestibular Stimulation (CVS) administered at Alfred Health by a clinician in a single testing session or for up to three separate sessions, with CVS never repeated on the same day. Participants receive CVS alone (up to three sessions), or CVS and ice-pack (up to 6 sessions in total). No patients receive ice-pack alone. If ice-pack and CVS are administered on the same day, it is always ice-pack first, with CVS administered at least 30 minutes after ice-pack application. The number of days separating repeat interventions (CVS or ice-pack) varies according to patient availability/choice. The range of days between interventions is from 1 to 1300 days. The number of sessions (CVS or ice-pack) varies according to patient availability/choice. The clinician determines whether CVS or the icepack control condition is administered on any particular day (with no specific factors determining this allocation). This is a non-randomised trial. Because session number was determined by patient availability/choice, no specific strategies are used to monitor adherence to the intervention. Total study duration is 5 years. CVS administered with patients seated or lying with their head angled forward 30° from horizontal. Up to 50mls of iced water (0–4°C) slowly irrigated into the right external ear canal using a syringe with attached plastic cannula tubing (with the needle removed) which is situated close to, but not touching, the tympanic membrane. Only right ear CVS applied to avoid a theoretical risk of worsening comorbid depression. To ensure maximal stimulation, irrigation continues for 5–10 seconds after nystagmus onset. CVS administration duration is around 3-5 minutes (onset of water irrigation to cessation of nystagmus) and total session time including outcome measure collection is around 1 hour.
Intervention code [1] 319530 0
Treatment: Other
Comparator / control treatment
The clinician administers the ice-pack by applying it to the patient‘s forehead until cold-related discomfort is reported to be unbearable. Ice-pack administration duration is around 2-5 minutes (onset of ice-pack application to its removal) and total session time including outcome measure collection is around 1 hour. Participants receive CVS alone (up to three sessions), or CVS and ice-pack (up to 6 sessions in total). No patients receive ice-pack alone. If ice-pack and CVS are administered on the same day, it is always ice-pack first, with CVS administered at least 30 minutes after ice-pack application. The number of days separating repeat interventions (CVS or ice-pack) varies according to patient availability/choice. The range of days between interventions is from 1 to 1300 days. The number of sessions (CVS or ice-pack) varies according to patient availability/choice. The clinician determines whether CVS or the icepack control condition is administered on any particular day (with no specific factors determining this allocation). This is a non-randomised trial. Because session number was determined by patient availability/choice, no specific strategies are used to monitor adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 326256 0
Subjective rating of persistent pain using Numerical Rating Scale for Pain Intensity (NRS-PI) scores from 0 ('no pain‘) to 10 ('worst pain imaginable‘).
Timepoint [1] 326256 0
Collected at:
(i) baseline (before any intervention);
(ii) after nystagmus settled for CVS (for ice-pack, roughly the same time after ice-pack placement);
(iii) 10 minutes post-intervention;
(iv) 20 minutes post-intervention;
(v) 30 minutes post-intervention; and
(vi) patients who showed pain reductions within the initial 24 hours followed up at approximately weekly intervals for up to four weeks.

The primary endpoint was 30 minutes post-intervention. Follow-up NRS-PI for pain used average pain ratings in the previous 24 hours.
Primary outcome [2] 326764 0
Subjective rating of allodynia in complex regional pain syndrome using Numerical Rating Scale for Pain Intensity (NRS-PI) scores from 0 ('no pain‘) to 10 ('worst pain imaginable‘). Dynamic allodynia examined using light finger stroke or tissue-paper stroke.
Timepoint [2] 326764 0
Collected at:
(i) baseline (before any intervention);
(ii) after nystagmus settled for CVS;
(iii) 10 minutes post-intervention;
(iv) 20 minutes post-intervention;
(v) 30 minutes post-intervention; and
(vi) patients who show allodynia reductions within the initial 24 hours followed up at approximately weekly intervals for up to four weeks.

The primary endpoint is 24 hours for allodynia. Follow-up NRS-PI for allodynia used: (i) the same stimulus when the patient was assessed in person; or (ii) self-reported general allodynia levels in the previous 24 hours when follow-up was conducted by phone.
Secondary outcome [1] 390760 0
Numerical rating scale for mood from 0 ('worst you have ever felt‘) to 10 ('best you have ever felt‘)
Timepoint [1] 390760 0
Collected:
(i) after nystagmus settled for CVS; and
(v) 30 minutes post-intervention.
Secondary outcome [2] 392615 0
Self-reported instances and intensity of CVS-induced discomfort/pain. This is recorded on a Likert scale from 0 (none) to 10 (worst possible).
Timepoint [2] 392615 0
Collected:
(i) after nystagmus settled for CVS; and
(v) 30 minutes post-intervention.
Secondary outcome [3] 409072 0
Self-reported instances and intensity of CVS-induced headache. This is recorded on a Likert scale from 0 (none) to 10 (worst possible).
Timepoint [3] 409072 0
Collected:
(i) after nystagmus settled for CVS; and
(v) 30 minutes post-intervention.
Secondary outcome [4] 409073 0
Self-reported instances and intensity of CVS-induced nausea/vomiting. This is recorded on a Likert scale from 0 (none) to 10 (worst possible).
Timepoint [4] 409073 0
Collected:
(i) after nystagmus settled for CVS; and
(v) 30 minutes post-intervention.
Secondary outcome [5] 409074 0
Self-reported willingness to repeat the intervention if it reduced their pain by 50% or more for 1 week or for 1 month. Yes or no answer to each (1 week and 1 month).
Timepoint [5] 409074 0
Collected at the end of the session.
Secondary outcome [6] 409075 0
Narrative reports of pain: qualitative reports of sensations, perceptions, and beliefs concerning pain-affected limbs.
Timepoint [6] 409075 0
Collected at:
(i) baseline (before any intervention);
(ii) 30 minutes post-intervention (covering the whole 30 minute period since the intervention).
(iii) at follow-up

Eligibility
Key inclusion criteria
(i) persistent pain (>3 months) at or below deafferentation level for phantom limb pain and spinal cord injury pain;
(ii) persistent pain (> 3months) in complex regional pain syndrome as diagnosed by treating pain clinician;
(iii) musculoskeletal persistent pain (> 3 months) for non-specific persistent pain patients.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) epilepsy or any brain disorder;
(ii) ear disease within the past five years;
(iii) pregnancy;
(iv) cardiac or respiratory disease (unless cleared by treating specialist);
(v) alcohol or substance dependence, or psychiatric comorbidity (except depression).
Absence of these conditions was confirmed via medical records and clinical interview.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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


Intervention assignment
Other
Other design features
Convenience-based non-randomised effectiveness trial with a single-blinded placebo control for short-term pain modulation effects. CVS and ice-pack control administered in a single testing session or for up to three separate sessions, with CVS never repeated on the same day. The number of days separating repeat interventions varied according to patient availability. A minimum period of 30 minutes between ice-pack and CVS when these administered on the same day. CVS never administered before ice-pack on the same day. No formal randomisation or decision algorithm regarding whether or not patient receives ice-pack prior to CVS. The people receiving the treatment are considered masked/blinded because although participants are aware of whether they are receiving CVS versus ice-pack, they are not aware that CVS is the active treatment and ice-pack is the cold-arousal control that does not induce vestibular stimulation. Rather, participants are informed that 'thermal stimulation' techniques are being investigated and they are not told which thermal stimulation technique is active and which is the control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated-measures MANOVA

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/06/2008
Date of last participant enrolment
Anticipated
Actual
30/09/2013
Date of last data collection
Anticipated
Actual
29/11/2013
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18471 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment hospital [2] 18472 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 32781 0
3101 - Kew
Recruitment postcode(s) [2] 32782 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 307603 0
Government body
Name [1] 307603 0
Victorian Neurotrauma Initiative
Country [1] 307603 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 308296 0
University
Name [1] 308296 0
Monash University
Address [1] 308296 0
Wellington Road, Clayton VIC 3800
Country [1] 308296 0
Australia
Other collaborator category [1] 281661 0
Hospital
Name [1] 281661 0
Austin Health
Address [1] 281661 0
145 Studley Road
PO Box 5555
Heidelberg Victoria 3084
Country [1] 281661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307658 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 307658 0
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 307658 0
Australia
Date submitted for ethics approval [1] 307658 0
Approval date [1] 307658 0
01/05/2008
Ethics approval number [1] 307658 0
145/07

Summary
Brief summary
The purpose of the project is to examine if caloric vestibular stimulation improves symptoms of persistent pain in phantom limb pain, spinal cord injury pain, complex regional pain syndrome and non-specific persistent pain. The CVS technique is a simple, non-invasive procedure that involves irrigating the ear with iced water. The comparator condition is a cold-arousal control involving an ice-pack placed on the forehead. The hypothesis is that CVS, but not the control ice-pack condition, will treat persistent pain. If the study is successful, the technique could be important as a treatment for managing persistent pain in people who have tried other treatments that have not worked or have caused side-effects, or as a non-invasive alternative treatment to current treatments. The results may also have particular importance for treatment in the developing world, where medication and other therapies are often unavailable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108034 0
Dr Steven Miller
Address 108034 0
Biomedicine Discovery Institute, Monash University
Rm F114, Bldg 13F, 26 Innovation Walk
Clayton, VIC, 3800
Country 108034 0
Australia
Phone 108034 0
+61 407636249
Fax 108034 0
Email 108034 0
[email protected]
Contact person for public queries
Name 108035 0
Steven Miller
Address 108035 0
Biomedicine Discovery Institute, Monash University
Rm F114, Bldg 13F, 26 Innovation Walk
Clayton, VIC, 3800
Country 108035 0
Australia
Phone 108035 0
+61 407636249
Fax 108035 0
Email 108035 0
[email protected]
Contact person for scientific queries
Name 108036 0
Steven Miller
Address 108036 0
Biomedicine Discovery Institute, Monash University
Rm F114, Bldg 13F, 26 Innovation Walk
Clayton, VIC, 3800
Country 108036 0
Australia
Phone 108036 0
+61 407636249
Fax 108036 0
Email 108036 0
[email protected]

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.