None listed
Conditions
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.
Interventions
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
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.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed