Vestibular neuromodulation for the treatment of persistent pain: An open label case series

Not Applicable

• Conditions: Persistent pain; Neck pain; Back pain; Limb pain; Neuropathic pain; Complex regional pain syndrome; Persistent post-surgery spinal pain syndrome; Nociplastic pain with central sensitisation; Post stroke central pain; Phantom limb pain

• Registration Number: ACTRN12624000216516
• Lead Sponsor: Dr Steven Miller

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-05
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with persistent pain (PP). This includes any pain condition that can present to a pain specialist, with the exception of spinal cord injury pain, visceral/abdominal/pelvic pain, and purely nociceptive musculoskeletal pain. A non- exhaustive list of the types of PP patients to be recruited includes those with: persistent neck pain, back pain, upper or lower limb pain, neuropathic pain (such as due to diabetes, chemotherapy, post-herpetic neuralgia, occipital neuralgia, trigeminal neuralgia), complex regional pain syndrome, failed back surgery syndrome (persistent post-spinal surgery pain syndrome), nociplastic pain with central sensitisation, post-stroke central pain syndrome (thalamic pain syndrome), and phantom limb pain.

Exclusion Criteria

(i) Younger than 18 or older than 70 (simple precaution exclusion)
(ii) Spinal cord injury pain, visceral/abdominal/pelvic pain, purely nociceptive pain (spinal cord injury patients did not appear to respond well to the CVS treatment in a previous study; visceral/abdominal/pelvic pain conditions are outside the scope of this study; purely nociceptive pain is unlikely to respond)
(iii) Somatic symptom disorder with predominant pain (i.e., a primary psychiatric pain disorder) or significant abnormal illness behaviour/non-organic presentation features (psychiatric pain disorders are outside the scope of the study and abnormal illness behaviour features could complicate data interpretation)
(iv) unstable medical condition (e.g. unstable cardiac or respiratory issues) (simple precaution exclusion)
(v) epilepsy (simple precaution exclusion)
(vi) brain injury, other than stroke with central pain being the targeted PP condition (simple precaution exclusion)
(vii) currently pregnant (simple precaution exclusion)
(viii) bipolar disorder, schizophrenia or other psychotic disorder (simple precaution exclusion and theoretical risk of exacerbating mood disorder symptoms)
(ix) significant ear disease in the right ear (or left ear if considering left ear CVS) (avoids risk of worsening any significant ear condition through having water irrigated into the ear canal)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent pain[Brief Pain Inventory pain score Brief Pain Inventory - Baseline, after 3rd and 6th CVS session, 6 weeks after last CVS session (primary timepoint), 6 months after last CVS session];Functional capacity[Brief Pain Inventory pain interference score Baseline, after 3rd and 6th CVS session, 6 weeks after last CVS session (primary timepoint), 6 months after last CVS session];Allodynia (in cases who have this clinical feature)[Assessed using light finger stroke or tissue-paper stroke and gentle pressure over the painful area, with the patient rating the pain induced using a NRS score. Baseline, before and after CVS (10mins and 20mins), daily via pain diary, 6 weeks after last CVS session (primary timepoint), 6 months after last CVS session.<br>For the daily assessment in the pain diary between CVS sessions, the patient self-tests in a similar way rather than the examiner.]