Clinical trial NCT06902233: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: Chronic low back pain
Brain stimulation
Transcranial infraslow grey noise stimulation
Randomised controlled trial
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
First posted: 2025-03-30
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Pain intensity
timeFrame: 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 outcomes:
measure: Pain intensity
timeFrame: Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment.
measure: Pain interference
timeFrame: Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.
measure: Pain unpleasantness
timeFrame: Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.
measure: Pain Bothersomeness
timeFrame: Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment.
measure: Patient global impression of change
timeFrame: Recorded at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Movement Evoked Pain: Repeated spinal bending
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Movement Evoked Pain: Back Performance scale
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Mechanical temporal summation
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Pressure Pain Threshold
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Function
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Health Related Quality of Life
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Well-Being
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Depression
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Catastrophizing
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Attention to pain
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Positive and Negative Affect
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Self-efficacy
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Intolerance to Uncertainity scale short form
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Tampa scale of Kinesiophobia
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
measure: Rescue analgesics / Concomitant treatment
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. QAQ will also be collected during intervention period, either at start of sessions (S1, S4, S7, S10) or after completion of the session (S12).
measure: Electroencephalography
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. EEG will also be collected during intervention phase either at start of the sessions (S1,S4,S7,S10) or after completion of sessions (S1 and S12).
measure: Emotional Stroop Task
timeFrame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. Stroop testing will be also be done during the intervention phase either at start of sessions (S4, S7, S10) or after completion of session (S12).
Other outcomes:
measure: Safety of the intervention
timeFrame: Recorded at all the intervention sessions and at one-week, one-month, three-months and six-months post-completion of intervention.
Locations:
city: Dunedin
country: New Zealand
facility: Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
state: Otago
Study officials:
affiliation: Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.
name: Divya Adhia, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: