Back to resultstDCS for Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sham transcranial direct current stimulation
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Back Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
sham tDCS
active tDCS
Arm Description
10 sessions sham transcranial direct current stimulation (tDCS)
10 sessions active transcranial direct current stimulation (tDCS)
Outcomes
Primary Outcome Measures
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]).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02771990
First Posted
May 12, 2016
Last Updated
March 27, 2023
Sponsor
Providence VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02771990
Brief Title
tDCS for Chronic Low Back Pain
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
10 sessions sham transcranial direct current stimulation (tDCS)
Arm Title
active tDCS
Arm Type
Experimental
Arm Description
10 sessions active transcranial direct current stimulation (tDCS)
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Intervention Description
sham stimulation
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
2 milliamp (mA) 20 minutes
Primary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Burgess, MD, PhD
Organizational Affiliation
Providence VA Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Greenberg, MD, PhD
Organizational Affiliation
Providence VA Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only de-identified data will be shared.
Learn more about this trial
tDCS for Chronic Low Back Pain
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