Brain Network Stimulation for Chronic Low Back Pain.

Launched by UNIVERSITY OF OTAGO · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with chronic low back pain (CLBP) called non-invasive brain stimulation. The goal is to see how well this treatment can reduce pain and improve everyday function. Researchers want to find out if this method is safe, what side effects might occur, and how people feel about the treatment process. Participants will be randomly assigned to either receive the actual brain stimulation or a placebo (sham stimulation) that doesn’t have any therapeutic effects.

To be eligible for the study, participants should be between the ages of 18 and 75 and have been experiencing lower back pain for at least half of the days over the last six months. They should also have a moderate level of pain and some level of disability related to their back pain. Those who have serious spinal issues, recent injuries, certain health conditions, or implants like pacemakers are not eligible to participate. If chosen for the study, participants will attend twelve one-hour sessions over four weeks. They will be assessed before the treatment begins and at various points afterward to track their progress. This trial is not yet recruiting participants, but it offers a chance to explore an innovative approach to managing chronic low back pain.

Gender

ALL

Eligibility 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.