tDCS for Chronic Low Back Pain

• Sponsor: Providence VA Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02771990
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Duration (Months): 54

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Device: Sham transcranial direct current stimulation; Device: transcranial direct current stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: tDCS for Chronic Low Back Pain: A Study Examining the Effect of Transcranial Direct Current Stimulation on the Emotional Response to Chronic Low Back Pain
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 3, 2018
• Actual Study Completion Date: Apr 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: sham tDCS 10 sessions sham transcranial direct current stimulation (tDCS)	Device: Sham transcranial direct current stimulation; sham stimulation
Experimental: active tDCS 10 sessions active transcranial direct current stimulation (tDCS)	Device: transcranial direct current stimulation; 2 milliamp (mA) 20 minutes

Outcome Measures

Primary Outcome Measures

1. West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating [8 weeks]

   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]).

2. Pain Anxiety Symptom Scale (PASS-20) Rating [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Providence VA Medical Center

Investigators

• Principal Investigator: Frederick Burgess, MD, PhD, Providence VA Medical Center
• Principal Investigator: Benjamin Greenberg, MD, PhD, Providence VA Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2018

More Information

Publications

None provided.

• Responsible Party: Benjamin Greenberg, Associate Director, CfNN, Providence VA Medical Center
• ClinicalTrials.gov Identifier: NCT02771990
• Other Study ID Numbers: 2013-042
• First Posted: May 13, 2016
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Benjamin Greenberg, Associate Director, CfNN, Providence VA Medical Center: Back Pain
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

Participant Flow

Pre-assignment Detail	Of the 30 participants that were consented, 9 participants were ineligible, withdrew, or were lost to contact before commencing tDCS.

Arm/Group Title	Sham tDCS	Active tDCS
Arm/Group Description	10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham stimulation	10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
Period Title: Overall Study
STARTED	11	10
COMPLETED	11	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sham tDCS	Active tDCS	Total
Arm/Group Description	10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham stimulation	10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes	Total of all reporting groups
Overall Participants	11	10	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.7 (1.8)	65.7 (8.8)	63.1 (10.5)
Sex: Female, Male (Count of Participants)
Female	2 18.2%	1 10%	3 14.3%
Male	9 81.8%	9 90%	18 85.7%
Race/Ethnicity, Customized (Count of Participants)
White	7 63.6%	7 70%	14 66.7%
Black or African American	1 9.1%	0 0%	1 4.8%
Hispanic or Latino	0 0%	1 10%	1 4.8%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or other Pacific Islander	0 0%	0 0%	0 0%
Other	3 27.3%	2 20%	5 23.8%
Years of Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.7 (2.6)	14.0 (2.6)	14.4 (2.7)

Outcome Measures

1. Primary Outcome

Title	West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) General Activity Subscale Rating
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham tDCS	Active tDCS
Arm/Group Description	10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham	10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	35.3 (17.7)	48.4 (21.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham tDCS, Active tDCS
	Comments
	Type of Statistical Test	Other
	Comments	Pilot study
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	z-score
	Estimated Value	3.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Pain Anxiety Symptom Scale (PASS-20) Rating
Description	The PASS-20 contains 20 items and scores could range from 0 to 100 (higher scores indicate greater pain anxiety).
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham tDCS	Active tDCS
Arm/Group Description	10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham	10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	26.4 (22.0)	26.3 (23.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham tDCS, Active tDCS
	Comments
	Type of Statistical Test	Other
	Comments	Pilot study
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Regression, Linear
	Comments

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Sham tDCS		Active tDCS
Arm/Group Description	10 sessions sham transcranial direct current stimulation (tDCS) Sham transcranial direct current stimulation: sham stimultion		10 sessions active transcranial direct current stimulation (tDCS) transcranial direct current stimulation: 2 milliamp (mA) 20 minutes
All Cause Mortality
	Sham tDCS		Active tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Serious Adverse Events
	Sham tDCS		Active tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Sham tDCS		Active tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)

Limitations/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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.