Brain network stimulation to reduce chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.