Brain network stimulation to reduce chronic low back pain
High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
NA · University of Otago · NCT06902233
This trial will try a non‑invasive brain stimulation technique called transcranial infraslow grey noise stimulation to reduce pain in adults with chronic low back pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Otago (other) |
| Locations | 1 site (Dunedin, Otago) |
| Trial ID | NCT06902233 on ClinicalTrials.gov |
What this trial studies
This randomized trial will assign participants with chronic low back pain to receive either active high‑definition transcranial infraslow grey noise stimulation or a sham (placebo) stimulation. Participants attend twelve roughly one‑hour sessions over four weeks (three sessions per week). Pain intensity, safety and participant experience will be measured at baseline, immediately after treatment, and at one, three, and six months after completion. The study aims to compare changes in pain and function between the active and sham groups and to document any side effects.
Who should consider this trial
Good fit: Adults aged 18–75 with chronic low back pain occurring at least half the days over the past six months, an average pain score of 4 or higher (0–10) in the week before enrolment, and a Roland‑Morris Disability Questionnaire score of 5 or more are the intended participants.
Not a fit: People with serious spinal pathology, recent back surgery or injections, active inflammatory or autoimmune disorders, suspected pregnancy, or other exclusionary medical conditions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If effective, this non‑invasive brain stimulation could reduce pain and improve function in people with chronic low back pain without requiring surgery or systemic medications.
How similar studies have performed: Other forms of non‑invasive brain stimulation for chronic pain have produced mixed but sometimes promising results, while transcranial infraslow grey noise stimulation is a newer, less‑tested variant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 to 75 years on the day of screening * Pain in the lower back (region between 12th rib and gluteal fold) with or without accompanying leg pain that occurs for at least half the days in the last six months * An average pain intensity of ≥4 on the 11-point NPRS (0=No pain to 10=Pain as bad as you can imagine) in the week prior to enrolment * A disability score of ≥5 on Roland-Morris Disability Questionnaire (RMDQ). Exclusion Criteria: * Known or suspected serious spinal pathology (fracture; lumbar canal stenosis, malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder) * Suspected or confirmed pregnancy or less than six months post-partum * Inflammatory disorders * Auto-immune conditions * Recent soft tissue injuries of the back in the last 3 months * Recent steroid injections to the back in the past 3 months * Recent spinal surgery in the past 12 months or scheduled/waiting for any major surgical procedures during the treatment or follow-up period or underwent rhizotomy or any neurosurgical procedures * History of neurological conditions, or psychiatric disorders (except depression and anxiety disorders) * History of cancer, or currently receiving/scheduled for receiving therapy for cancer * Cognitive impairments (dementia, Alzheimer's disease; indicated by a total score of 24 or below on Mini-Mental State Examination) * Alcohol or substance abuse * History of epilepsy or seizures * Presence of any electronic implants (e.g., pacemaker), metal implant in the body (particularly head and neck), or spinal cord stimulator.
Where this trial is running
Dunedin, Otago
- Department of Surgical Sciences, Dunedin School of Medicine, University of Otago — Dunedin, Otago, New Zealand (RECRUITING)
Study contacts
- Principal investigator: Divya Adhia, Ph.D — Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.
- Study coordinator: Divya Adhia, Ph.D
- Email: divya.adhia@otago.ac.nz
- Phone: 0064211167594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Low Back Pain, Chronic low back pain, Brain stimulation, Transcranial infraslow grey noise stimulation, Randomised controlled trial