Brain Network Stimulation for Chronic Low Back Pain.

Official title

High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.

Overview

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.

Interventions

• Device High-definition transcranial infraslow grey noise stimulation
  HD-tIGNS will be administered three times a week (30 minutes/ session) for a total of 4 weeks (i.e., 12 sessions in total) using a 32-channel transcranial current stimulator. The HD-tIGNS will be used to alter the functional connectivity strength between the three cortical networks \[namely the salience network (SN), the default mode network (DMN) and the somatomotor network (SMN)\] in the infraslow frequency spectrum (0.1 Hz). A total of fifteen circular Ag/AgCl electrodes \[eleven stimulation
• Device Sham Comparator
  The Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics will be used for the sham stimulation group. Similar to the active treatment group, the actisham will be administered three times a week (30 minutes/ session) for a total of 4 weeks (i.e., 12 sessions in total) using a 32-channel transcranial current stimulator.Similar to active group, a total of fifteen circular Ag/AgCl electrodes will be placed on a neoprene head cap following the International 10-10 EEG syst

Primary outcome measures

• Pain intensity [Time frame: The primary endpoint for efficacy assessment of HD-tIGNS will be change in the average pain intensity over the past week from baseline to one-week post completion of treatment.]

Secondary outcome measures (12)

• Pain intensity [Time frame: Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment.]
• Pain interference [Time frame: Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.]
• Pain unpleasantness [Time frame: Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.]
• Pain Bothersomeness [Time frame: Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment.]
• Patient global impression of change [Time frame: Recorded at one-week, one-month, three-months, and six-months post completion of treatment.]
• Movement Evoked Pain: Repeated spinal bending [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Movement Evoked Pain: Back Performance scale [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Mechanical temporal summation [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Pressure Pain Threshold [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Function [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Health Related Quality of Life [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]
• Well-Being [Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

New Zealand · 1 center

• Department of Surgical Sciences, Dunedin School of Medicine, University of Otago — Dunedin

Publications

• Adhia DB, Mani R, Reynolds J, Glue P, Potiki J, Vanneste S, De Ridder D. Functional connectivity-targeted high-definition transcranial infraslow grey noise stimulation for chronic low back pain: protocol for a double-blinded, randomised, controlled clinical trial. BMJ Open. 2025 Aug 24;15(8):e103019. doi: 10.1136/bmjopen-2025-103019. PMID 40850927

Identifiers

NCT: NCT06902233 · 2024 FULL 21891 · 24-176

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗