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In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum acupuncture + real tDCS | Experimental |
| |
| sham acupuncture + real tDCS | Experimental |
| |
| verum acupuncture + sham tDCS | Experimental |
| |
| sham acupuncture + sham tDCS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verum acupuncture | Device | Participants will receive real acupuncture treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes | We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the periaqueductal gray (PAG). This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC, peak MNI coordinate (2, 38, 12) with a 2-mm radius sphere). Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln[(1 + r) / (1 - r)]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention reflect the degree and direction of connectivity modulation. | difference between Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - Post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes as Measured by LBP Intensity Scores | The Low Back Pain Numeric Rating Scale (LBP NRS) is a standardized adaptation of the Pain Numeric Rating Scale for assessing pain intensity specifically related to the lower back. It uses an 11-point scale from 0 ("no low back pain") to 10 ("worst low back pain imaginable"), allowing patients to rate their pain over the past week. | Difference between the Day 1 (pre-intervention) and post-intervention at Week 4 (post-intervention - pre-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129-2020 | United States |
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The recruitment started on Nov, 07, 2020. The study was conducted at Massachusetts General Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum Acupuncture + Real tDCS | verum acupuncture: Participants will receive real acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
| FG001 | Sham Acupuncture + Real tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
| FG002 | Verum Acupuncture + Sham tDCS | verum acupuncture: Participants will receive real acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
| FG003 | Sham Acupuncture + Sham tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Data analysis was performed based on group distribution.
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum Acupuncture + Real tDCS | verum acupuncture: Participants will receive real acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
| BG001 | Sham Acupuncture + Real tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes | We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the periaqueductal gray (PAG). This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC, peak MNI coordinate (2, 38, 12) with a 2-mm radius sphere). Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln[(1 + r) / (1 - r)]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention reflect the degree and direction of connectivity modulation. | Individuals with chronic low back pain | Posted | Mean | Standard Deviation | Fisher z-transformed correlation coeffic | difference between Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - Post-intervention) |
from baseline to post-intervention assessments, up to 6 weeks
Same as clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum Acupuncture + Real tDCS | verum acupuncture: Participants will receive real acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | SNOMED CT | Systematic Assessment | Some participants experienced headaches during and after the intervention, which resolved spontaneously without the need for additional treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jian Kong, PI of the clinical trial | Massachusetts General Hospital | 6177267893 | kongj@nmr.mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2023 | Jul 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomized to one of four groups: 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS.
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Both participants and study staff will be blinded to the treatment group of participants. Only the licensed acupuncturist will be aware of the type of acupuncture the participant will be receiving.
| sham acupuncture | Device | Participants will receive sham acupuncture treatment. |
|
| real tDCS | Device | Participants will receive real transcranial direct current stimulation. |
|
| sham tDCS | Device | Participants will receive sham transcranial direct current stimulation. |
|
| Cerebral Blood Flow (CBF) Differences Before and After Treatments | Investigators will examine Cerebral blood flow (CBF) changes before and after treatment in several pain-related brain areas. Cerebral blood flow represents the volume of blood delivered to brain tissue per unit time, CBF data will be collected during arterial spin labeling (ASL) scans that will take place before the first treatment and after the last treatment. Images from these scans will be aggregated to an average CBF-weighted image to be used for analysis. In this report, we focused on bilateral postcentral Gyrus (MNI coordinate: +/-18, -34, 56, 2 mm sphere) | Day 1 (pre-intervention); post-intervention at Week 4 |
| Quantitative Sensory Testing (QST) Differences | Participants' quantitative sensory testing (QST) ratings were analyzed before and after all treatments. Here, we report the heat pain threshold measured around the affected lower back area. | Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention) |
| Primary Motor Cortex (M1) rsFC Changes Before and After 4-week Treatments | We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the M1. This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC), using a seed defined by the rACC peak MNI coordinate (0, 34, 20) with a 2-mm radius sphere. Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln[(1 + r) / (1 - r)]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention | Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention) |
| Adverse Event |
|
| Lost to Follow-up |
|
sham acupuncture: Participants will receive sham acupuncture treatment.
real tDCS: Participants will receive real transcranial direct current stimulation.
| BG002 | Verum Acupuncture + Sham tDCS | verum acupuncture: Participants will receive real acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
| BG003 | Sham Acupuncture + Sham tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Verum Acupuncture + Real tDCS | verum acupuncture: Participants will receive real acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
| OG001 | Sham Acupuncture + Real tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. |
| OG002 | Verum Acupuncture + Sham tDCS | verum acupuncture: Participants will receive real acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
| OG003 | Sham Acupuncture + Sham tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. |
|
|
| Secondary | Clinical Outcomes as Measured by LBP Intensity Scores | The Low Back Pain Numeric Rating Scale (LBP NRS) is a standardized adaptation of the Pain Numeric Rating Scale for assessing pain intensity specifically related to the lower back. It uses an 11-point scale from 0 ("no low back pain") to 10 ("worst low back pain imaginable"), allowing patients to rate their pain over the past week. | individuals with chronic low back pain | Posted | Mean | 95% Confidence Interval | score on a scale | Difference between the Day 1 (pre-intervention) and post-intervention at Week 4 (post-intervention - pre-intervention) |
|
|
|
| Secondary | Cerebral Blood Flow (CBF) Differences Before and After Treatments | Investigators will examine Cerebral blood flow (CBF) changes before and after treatment in several pain-related brain areas. Cerebral blood flow represents the volume of blood delivered to brain tissue per unit time, CBF data will be collected during arterial spin labeling (ASL) scans that will take place before the first treatment and after the last treatment. Images from these scans will be aggregated to an average CBF-weighted image to be used for analysis. In this report, we focused on bilateral postcentral Gyrus (MNI coordinate: +/-18, -34, 56, 2 mm sphere) | chronic low back pain patients | Posted | Mean | Standard Deviation | mL/s | Day 1 (pre-intervention); post-intervention at Week 4 |
|
|
|
| Secondary | Quantitative Sensory Testing (QST) Differences | Participants' quantitative sensory testing (QST) ratings were analyzed before and after all treatments. Here, we report the heat pain threshold measured around the affected lower back area. | patients with chronic low back pain | Posted | Mean | Standard Deviation | degrees Celsius | Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention) |
|
|
|
| Secondary | Primary Motor Cortex (M1) rsFC Changes Before and After 4-week Treatments | We investigated whether tDCS and acupuncture treatments modulate resting-state functional connectivity (rsFC) of the M1. This was evaluated by comparing pre- and post-treatment MRI scans. In this report, we focused on the rsFC between the PAG and the rostral anterior cingulate cortex (rACC), using a seed defined by the rACC peak MNI coordinate (0, 34, 20) with a 2-mm radius sphere. Functional connectivity values were computed as Pearson's correlation coefficients between the mean time series of predefined regions of interest (ROIs). To improve normality and enable parametric statistical analysis, these correlation coefficients (r) were converted to Fisher z values using the transformation z = 0.5 × ln[(1 + r) / (1 - r)]. Higher Fisher z values indicate stronger positive connectivity, whereas lower values indicate weaker or negative connectivity. Changes in Fisher z values from baseline to post-intervention | low back pain patients | Posted | Mean | Standard Deviation | Fisher z-transformed correlation coeffic | Day 1 (pre-intervention); post-intervention at Week 4 (pre-intervention - post-intervention) |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Sham Acupuncture + Real tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. real tDCS: Participants will receive real transcranial direct current stimulation. | 0 | 25 | 0 | 25 | 1 | 25 |
| EG002 | Verum Acupuncture + Sham tDCS | verum acupuncture: Participants will receive real acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Sham Acupuncture + Sham tDCS | sham acupuncture: Participants will receive sham acupuncture treatment. sham tDCS: Participants will receive sham transcranial direct current stimulation. | 0 | 23 | 0 | 23 | 3 | 23 |
|
| Needle pain discomfort | General disorders | SNOMED CT | Systematic Assessment | A participant reported residual needle discomfort after the intervention. |
|
| Neck pain | General disorders | SNOMED CT | Systematic Assessment | a participant reported neck pain that believed not related to this study. |
|
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