CompletedNCT02771990Updated Mar 29, 2023Results posted

tDCS for Chronic Low Back Pain

An interventional study of Sham transcranial direct current stimulation and transcranial direct current stimulation in Chronic Low Back Pain, sponsored by Providence VA Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Providence VA Medical Center · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The goal of this study is to investigate the role of central neural pathways in mediating chronic pain. The aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS). Prior studies have used tDCS to target both sensory related cortical areas and those important for higher-order representations of pain. This study will target brain regions important for the behavioral response to the chronic sensation of pain. The hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. This hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (CLBP) of greater than six months using tDCS. To be part of this study, participants must meet all the inclusion and exclusion criteria.

Conditions studied

Chronic Low Back Pain

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Keywords

Back Pain

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Chronic Low Back Pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month
At least one trial of physician recommended medication (e.g. acetaminophen, NSAIDS, skeletal muscle relaxants)
Pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month)
Be able to understand, read and write English
If female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method)

Exclusion criteria

Exclusion Criteria:

Lifetime Diagnostic and Statistical Manual (DSM) IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition
Current DSM-IV diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine
Current cancer, infection, or inflammatory arthritis
Broken skin or other lesions in the area of the electrodes
Uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation
Presence of metal in the cranial cavity
Holes in the skull made by trauma or surgery
Pacemakers, medication pumps, and other implanted electronic hardware
Pregnancy

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 30 participants (actual)

Study arms

Sham comparator
sham tDCS
10 sessions sham transcranial direct current stimulation (tDCS)
Device: Sham transcranial direct current stimulation
Experimental
active tDCS
10 sessions active transcranial direct current stimulation (tDCS)
Device: transcranial direct current stimulation

Interventions

DeviceSham transcranial direct current stimulation
sham stimulation
Devicetranscranial direct current stimulation
2 milliamp (mA) 20 minutes

What researchers measure

Primary outcomes

West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating
The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity \[better\]).
Time frame: 8 weeks
Pain Anxiety Symptom Scale (PASS-20) Rating
The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety).
Time frame: 8 weeks

Results

Posted May 4, 2021

Limitations and caveats

small sample size (N = 21), participants were not stratified by premorbid anxiety levels, inability to guarantee optimal targeting of the left dorsal anterior cingulate cortex, inability to address laterality effects of pain perception

Participant flow

Participant flow — Overall Study
Milestone	Sham tDCS	Active tDCS
Started	11	10
Completed	11	10
Not completed	0	0

Outcome measures

PrimaryWest Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating

The WHY-MPI General Activity subscale contains 18 items summed to give a score ranging from 0 to 108 (higher scores indicate more activity \[better\]).

Time frame:: 8 weeks
Reported as:: Mean · score on a scale

West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating
score on a scale	Sham tDCS	Active tDCS
West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating	35.3 ± 17.7	48.4 ± 21.2

Statistical analysis

Sham tDCS vs Active tDCS · Regression, Linear · p = 0.002 · Z-score: 3.11

PrimaryPain Anxiety Symptom Scale (PASS-20) Rating

The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety).

Time frame:: 8 weeks
Reported as:: Mean · score on a scale

Pain Anxiety Symptom Scale (PASS-20) Rating
score on a scale	Sham tDCS	Active tDCS
Pain Anxiety Symptom Scale (PASS-20) Rating	26.4 ± 22.0	26.3 ± 23.6

Statistical analysis

Sham tDCS vs Active tDCS · Regression, Linear · p = 0.67

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sham tDCS	0/11 (0%)	0/11 (0%)	0/11 (0%)
Active tDCS	0/10 (0%)	0/10 (0%)	0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Sham tDCS	Active tDCS	Total
Mean	60.7 ± 1.8	65.7 ± 8.8	63.1 ± 10.5

Sex: Female, Male
Sex: Female, Male(Participants)	Sham tDCS	Active tDCS	Total
Female	2	1	3
Male	9	9	18

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Sham tDCS	Active tDCS	Total
White	7	7	14
Black or African American	1	0	1
Hispanic or Latino	0	1	1
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or other Pacific Islander	0	0	0
Other	3	2	5

Years of Education
Years of Education(years)	Sham tDCS	Active tDCS	Total
Mean	14.7 ± 2.6	14.0 ± 2.6	14.4 ± 2.7

Study locations

No study locations are listed for this record.

References and documents

Study documents

Protocol and statistical analysis plan · Jun 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Only de-identified data will be shared.

Registry details

Key details

Study ID: NCT02771990
Lead sponsor: Providence VA Medical Center
Responsible party: Benjamin Greenberg (Associate Director, CfNN, Providence VA Medical Center) — Principal investigator
First posted: May 13, 2016
Start date: Oct 2013
Primary completion: Apr 3, 2018
Completion: Apr 3, 2018
Results posted: May 4, 2021
Last update: Mar 29, 2023

Study contacts

Frederick Burgess, MD, PhD

principal investigator · Providence VA Medical Center

Benjamin Greenberg, MD, PhD

principal investigator · Providence VA Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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