Status:
RECRUITING
Brain Network Stimulation for Chronic Low Back Pain.
Lead Sponsor:
University of Otago
Collaborating Sponsors:
Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
Conditions:
Chronic Low Back Pain (CLBP)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study looks at the non-invasive brain stimulation technique in people with chronic low back pain to see: * How effective non-invasive brain stimulation is at improving pain intensity in people w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06902233
Start Date
June 12 2025
End Date
January 1 2028
Last Update
July 31 2025
Active Locations (1)
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1
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
Dunedin, Otago, New Zealand, 9013