Actively Recruiting
Brain Network Stimulation for Chronic Low Back Pain.
Led by University of Otago · Updated on 2025-07-31
164
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
U
University of Otago
Lead Sponsor
D
Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 with chronic low back pain? * How safe non-invasive brain stimulation is and what side effects there may be? * What study participants think of the study procedures and of the non-invasive brain stimulation as a treatment technique for chronic low back pain. Participants will be assigned to receive either active brain stimulation group or sham stimulation group randomly. Participants will be required to attend a total of twelve treatment sessions (approximately 1-hour each, three sessions per week, for four consecutive weeks). Assessments will be done at baseline (in the week 0), immediately post-completion of the intervention (in the week 5), and at the follow-up of one-month (in the week 8), three-months (in the week 16) and six-months (in the week 28) post-completion of intervention.
CONDITIONS
Official Title
Brain Network Stimulation for Chronic Low Back Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 leg pain occurring at least half the days in the last six months
- Average pain intensity of 4 or higher on an 11-point pain scale in the week before enrollment
- Disability score of 5 or higher on the Roland-Morris Disability Questionnaire
You will not qualify if you...
- Known or suspected serious spinal conditions such as fracture, lumbar canal stenosis, malignant, inflammatory, or infectious spine diseases, cauda equina syndrome, or widespread neurological disorder
- Pregnancy or less than six months postpartum
- Inflammatory disorders or autoimmune conditions
- Recent soft tissue injuries of the back within the last 3 months
- Steroid injections to the back within the last 3 months
- Spinal surgery within the past 12 months or scheduled major surgery during the study period
- History of neurological or psychiatric disorders except depression and anxiety
- History of cancer or current cancer treatment
- Cognitive impairments indicated by a Mini-Mental State Examination score of 24 or below
- Alcohol or substance abuse
- History of epilepsy or seizures
- Presence of electronic implants, metal implants in the body especially head and neck, or spinal cord stimulators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
Dunedin, Otago, New Zealand, 9013
Actively Recruiting
Research Team
D
Divya Adhia, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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