Ignite Creation Date:
2025-12-25 @ 2:57 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT06902233
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Network Stimulation for Chronic Low Back Pain.
Sponsor:
University of Otago
Organization:
Study Overview
Official Title:
High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 24-176 | OTHER_GRANT | Health Research Council of New Zealand | View |