Chronic Low Back Pain (CLBP)NCT06902233
Brain Network Stimulation for Chronic Low Back Pain.
A study testing High-definition transcranial infraslow grey noise stimulation in people with Chronic Low Back Pain (CLBP), run by University of Otago at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- High-definition transcranial infraslow grey noise stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteNew Zealand
- Study dates
- 12 Jun 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site, 1 recruiting
- Recruiting
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
Dunedin, Otago, 9013
Divya Adhia, Ph.D, 0064211167594, divya.adhia@otago.ac.nz
Divya Adhia, Ph.D
About this study
Official title: High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
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.
Read more
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
- Chronic Low Back Pain (CLBP)
- Being tested
- High-definition transcranial infraslow grey noise stimulation, Sham Comparator
- Keywords
- Chronic low back pain, Brain stimulation, Transcranial infraslow grey noise stimulation, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition transcranial infraslow grey noise stimulationDevice
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 electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) and four electrodes with zero current (FC1, FC2, FC4, and FCz)] will be placed on a neoprene head cap following the International 10-10 EEG system. The optimal montages has been created using the Stimweaver optimization software by the Neuroelectrics company, to specifically decrease the functional connectivity i.e., phase synchronization of the brain regions of the SN with the SMN and the DMN.
Sham ComparatorDevice
Also called Sham stimulation, Actisham stimulation
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 system to appropriately blind the participant. The electrodes would comprise of four stimulation electrodes (FC1, FC2, FC4, and FCz) and eleven electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) with zero current.
| Study group | Role | What they receive |
|---|---|---|
| High definition transcranial infraslow gray noise stimulation (HD-tIGNS) | Experimental | For the active stimulation group, the HD-tIGNS will be delivered for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA. Receives: Device: High-definition transcranial infraslow grey noise stimulation |
| Sham stimulation | Sham comparator | For the sham stimulation group, to create an identical skin sensation to the active stimulation, we will use the Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics. The current will be applied for a 5s ramp up and 5s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. The sham session will last as long as the HD-tIGNS session to blind the procedure appropriately. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Average pain intensity over the past week measured on a numeric pain rating scale (NPRS) of 0 to 10 (0=No pain to 10=Pain as bad as you can imagine) from the Brief Pain Inventory short form
Measured: 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 (22)
Pain intensity
Average pain intensity over the past week measured on a NPRS of 0 to 10 (0=No pain to 10=Pain as bad as you can imagine) from the Brief Pain Inventory short form.
Measured: 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
Brief Pain Inventory (BPI), a standardised, validated questionnaire, will be used to capture pain interference in daily activities
Measured: Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.
Pain unpleasantness
Pain unpleasantness (affective component) in past one week measured on an 11-point NPRS-unpleasantness scale.
Measured: Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.
Pain Bothersomeness
Pain bothersomeness in past one week measured on an 11-point NPRS-bothersomeness scale.
Measured: 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
Patient global impression of change (PGIC) 7-point scale will be used to evaluate participants perception of overall improvement compared to baseline.
Measured: Recorded at one-week, one-month, three-months, and six-months post completion of treatment.
Movement Evoked Pain: Repeated spinal bending
Participants will be asked to perform 20 repetitions each of 2 repeated spinal bending tasks (forward and backward bending) independently, with at least a 10-15 minute rest in between. Participants will rate their pain intensity on a NPRS (0=no pain to 100=worst pain imaginable) before commencing the movements, then following every 5 repetitions.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Movement Evoked Pain: Back Performance scale
Back Performance scale (BPS) will be used to assess movement evoked pain (MEP) intensity during five functional tasks. Participants will be asked to rate their "pain rating at worst" during each task on a 0 to 100 NPRS. An MEP intensity composite score will be calculated by averaging pain ratings for the 5 tasks, with higher scores indicating greater MEP intensity.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Mechanical temporal summation
Mechanical temporal summation (MTS): will be assessed using a nylon monofilament (Semmes monofilament 6.65, 300 g) at the most painful low back region (nominated by the participant) and the non-dominant wrist (distant region). Brief 10 repetitive contacts will be delivered at a rate of 1 Hz, externally cued by auditory stimuli. Participants will be asked to rate the level of pain experienced on NRS (0=no pain to 100=extreme pain) immediately after the first contact and to rate their greatest pain intensity after the 10th contact; with the difference representing the maximum amount of MTS across 10 contact points. Average of three trials will be calculated, with a positive score indicating an increase in MTS. The MTS index will be defined as the ratio of 'follow-up' pain rating divided by 'baseline' pain rating.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Pressure Pain Threshold
Pressure pain threshold (PPT) will be assessed over the most painful low back region (nominated by the participant) and the non-dominant wrist (distant region) using a computerized, handheld digital algometer (AlgoMed; Medoc, Ramat Yishai, Israel) probe pressed over marked test site at a rate of 30 kPa/s. Participants will press the algometer trigger button in the patient control unit when pressure sensation changes to first pain. Average of three trials will be calculated and used for analysis
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Function
Roland-Morris Disability Questionnaire (RMDQ) will be used to assess self-reported functional abilities; within-group MCID is 30% decrease from baseline.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Health Related Quality of Life
European Quality of Life-5 Dimensions scale will be used to assess the health-related quality of life; within-group MCID is 0.03 and 10.5 from baseline for the health index and the thermometer respectively.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Well-Being
World Health Organization- Five Well-Being Index (WHO-5) will be used to measure the participant's current mental wellbeing.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Depression
Depression and Somatic Symptoms Scale (DSSS) will be used to evaluate the severity of depression (cutoff score of ≥15).
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Catastrophizing
Pain Catastrophizing Scale (PCS) will be used to measure the extent of catastrophic thoughts and feelings about their pain.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Attention to pain
Pain Vigilance and Awareness Questionnaire (PVAQ) will be used to measure the frequency of habitual 'attention to pain' over the past two weeks.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Positive and Negative Affect
Positive and Negative Affect Schedule (PANAS-short form) will be used to measure the two-dominant dimensions of affect style, positive and negative affect.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Self-efficacy
Pain self-efficacy (PSE), a 2-item questionnaire, will be used to assess pain self-efficacy beliefs.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Intolerance to Uncertainity scale short form
Intolerance of uncertainty (IUS) scale- short form (12 item), will be used to assess how individuals perceive and respond to uncertainty in their daily lives. Total score ranges between 5 to 60 with higher scores indicating higher levels of intolerance to uncertainity.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Tampa scale of Kinesiophobia
Tampa Scale of Kinesiophobia (TSK-11), will be used to quantify fear of movement. The scores ranges from 11 to 44, where higher scores indicate greater fear of pain, movement, and injury.
Measured: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Rescue analgesics / Concomitant treatment
The Quantitative analgesic questionnaire (QAQ) will be used to capture daily medication usage and a score will be generated to calculate weekly average pain medication use throughout the study. Other concomitant treatments including exercises, healthcare visits, etc. with the type and dosage will also be recorded throughout the study period using a diary.
Measured: 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).
Electroencephalography
Resting-state eyes closed electroencephalogram (EEG) (~10 minutes) will be obtained using SynAmps RT Amplifier (Compudemics Neuroscan) with 64 electrodes placed in the standard 10-10 International placement. During the intervention phase, resting state EEG will be collected using the Neuroelectrics Starstim32 system.
Exact low-resolution brain electromagnetic tomography (eLORETA), will be used through the LORETA-key software package to estimate the intracerebral electrical sources that generate scalp-recorded electrical activity. Lagged phase synchronization will be used as a measure of functional connectivity and will be calculated between the targeted brain regions (i.e., dorsal anterior cingulate cortex, Somatosemsory cortex, motor cortex, Insula, pregenual anterior cingulate cortex) in the infraslow frequency band (0.1Hz).
Measured: 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).
Emotional Stroop Task
Participants will be presented with words from 3 interference categories (Sensory pain-related, Affective pain-related, and Positive-emotional) and 3 control categories (comprising of matched neutral words) in four different colours (blue, red, yellow, green) and will be asked to press one of four response keys to indicate the colour of the words regardless of their meaning. The participant's response, the correctness of the response, and the response latency (in ms) of each of the 6 different categories will be recorded. Each word will be displayed for 1.5s and there will be 16 words in a 24s block. A single trial will be conducted, and it will include 16 blocks, i.e., 2 blocks for each word-type, 2 blocks for each corresponding control word set, and four fixation-cross (rest) blocks (24s duration) presented on the screen at the beginning and twice within a trial. The average of two test blocks will be calculated and used for analysis.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start12 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Otago
- Sponsor type
- University, hospital or other
- Collaborators
- Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
- Responsible party
- Sponsor
- Investigators
- Divya Adhia, Ph.D, Principal investigator, Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902233
- Sponsor's protocol ID
- 2024 FULL 21891
- Other IDs
- 24-176
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised participant data will be available from the Principal Investigator upon reasonable request for future research.
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.
PubMed 40850927
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06902233
- Acronym / sponsor ID
- 2024 FULL 21891
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- Chronic low back pain, Brain stimulation, Transcranial infraslow grey noise stimulation, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High definition transcranial infraslow gray noise stimulation (HD-tIGNS) | Experimental | Device: High-definition transcranial infraslow grey noise stimulationFor the active stimulation group, the HD-tIGNS will be delivered for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA. |
| Sham stimulation | Sham comparator | Device: Sham ComparatorFor the sham stimulation group, to create an identical skin sensation to the active stimulation, we will use the Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics. The current will be applied for a 5s ramp up and 5s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. The sham session will last as long as the HD-tIGNS session to blind the procedure appropriately. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-definition transcranial infraslow grey noise stimulationHD-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 electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) and four electrodes with zero current (FC1, FC2, FC4, and FCz)] will be placed on a neoprene head cap following the International 10-10 EEG system. The optimal montages has been created using the Stimweaver optimization software by the Neuroelectrics company, to specifically decrease the functional connectivity i.e., phase synchronization of the brain regions of the SN with the SMN and the DMN. | Device | High definition transcranial infraslow gray noise stimulation (HD-tIGNS) |
| Sham ComparatorAlso: Sham stimulation, Actisham stimulationThe 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 system to appropriately blind the participant. The electrodes would comprise of four stimulation electrodes (FC1, FC2, FC4, and FCz) and eleven electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) with zero current. | Device | Sham stimulation |
Primary outcome
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.
Average pain intensity over the past week measured on a numeric pain rating scale (NPRS) of 0 to 10 (0=No pain to 10=Pain as bad as you can imagine) from the Brief Pain Inventory short form
22 secondary outcomes
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.
Depression
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Catastrophizing
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Attention to pain
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Positive and Negative Affect
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Self-efficacy
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Intolerance to Uncertainity scale short form
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Tampa scale of Kinesiophobia
Time frame: Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment.
Rescue analgesics / Concomitant treatment
Time frame: 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).
Electroencephalography
Time frame: 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).
Emotional Stroop Task
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 40850927Adhia 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.
- Individual participant dataSharing planned: Yes. All anonymised participant data will be available from the Principal Investigator upon reasonable request for future research.
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Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
RecruitingObservational study
Exploring Multidimensional Trajectories in People With Low Back Pain
Acute Low Back Pain, Chronic Low Back Pain (CLBP)
Recruiting
PRT for Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Nociplastic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Divya Adhia, Ph.D principal investigator
Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition transcranial infraslow grey noise stimulation in people with Chronic Low Back Pain (CLBP), run by University of Otago at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Divya Adhia, Ph.D (0064211167594, divya.adhia@otago.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.