Brain Network Stimulation for Chronic Low Back Pain.
NCT06902233, Not applicable, Recruiting, University of Otago
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Network Stimulation for Chronic Low Back Pain. | ClinicalTrials.gov |
| NCT number | NCT06902233 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 164 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Otago | ClinicalTrials.gov |
| Conditions | Chronic Low Back Pain (CLBP) | ClinicalTrials.gov |
| Interventions | High-definition transcranial infraslow grey noise stimulation, Sham Comparator | ClinicalTrials.gov |
| First posted | 2025-03-30 | ClinicalTrials.gov |
| Last updated | 2025-07-31 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pain intensity | 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 | ClinicalTrials.gov |
| Secondary | Pain intensity | Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Pain interference | Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment. | Brief Pain Inventory (BPI), a standardised, validated questionnaire, will be used to capture pain interference in daily activities | ClinicalTrials.gov |
| Secondary | Pain unpleasantness | Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment. | Pain unpleasantness (affective component) in past one week measured on an 11-point NPRS-unpleasantness scale. | ClinicalTrials.gov |
| Secondary | Pain Bothersomeness | Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment. | Pain bothersomeness in past one week measured on an 11-point NPRS-bothersomeness scale. | ClinicalTrials.gov |
| Secondary | Patient global impression of change | Recorded at one-week, one-month, three-months, and six-months post completion of treatment. | Patient global impression of change (PGIC) 7-point scale will be used to evaluate participants perception of overall improvement compared to baseline. | ClinicalTrials.gov |
| Secondary | Movement Evoked Pain: Repeated spinal bending | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Movement Evoked Pain: Back Performance scale | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Mechanical temporal summation | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Pressure Pain Threshold | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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 | ClinicalTrials.gov |
| Secondary | Function | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Roland-Morris Disability Questionnaire (RMDQ) will be used to assess self-reported functional abilities; within-group MCID is 30% decrease from baseline. | ClinicalTrials.gov |
| Secondary | Health Related Quality of Life | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Well-Being | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | World Health Organization- Five Well-Being Index (WHO-5) will be used to measure the participant's current mental wellbeing. | ClinicalTrials.gov |
| Secondary | Depression | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Depression and Somatic Symptoms Scale (DSSS) will be used to evaluate the severity of depression (cutoff score of ≥15). | ClinicalTrials.gov |
| Secondary | Catastrophizing | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Pain Catastrophizing Scale (PCS) will be used to measure the extent of catastrophic thoughts and feelings about their pain. | ClinicalTrials.gov |
| Secondary | Attention to pain | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Pain Vigilance and Awareness Questionnaire (PVAQ) will be used to measure the frequency of habitual 'attention to pain' over the past two weeks. | ClinicalTrials.gov |
| Secondary | Positive and Negative Affect | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Positive and Negative Affect Schedule (PANAS-short form) will be used to measure the two-dominant dimensions of affect style, positive and negative affect. | ClinicalTrials.gov |
| Secondary | Self-efficacy | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | Pain self-efficacy (PSE), a 2-item questionnaire, will be used to assess pain self-efficacy beliefs. | ClinicalTrials.gov |
| Secondary | Intolerance to Uncertainity scale short form | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
| Secondary | Tampa scale of Kinesiophobia | Recorded at baseline, and at one-week, one-month, three-months, and six-months post completion of treatment. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40850927 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)