Chronic Low Back PainNCT02768129
Transcranial Direct Current Stimulation for Chronic Low Back Pain
A study testing transcranial direct current stimulation in people with Chronic Low Back Pain, run by Butler Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to 4 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Holes in the skull made by trauma or surgery
- Pacemakers, medication pumps, and other implanted electronic hardware
- Pregnancy
About this study
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
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
- Chronic Low Back Pain
- Being tested
- transcranial direct current stimulation, sham transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
active stimulation: 2 milliamp (mA), 20 mins
sham transcranial direct current stimulationDevice
sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Sham comparator | 10 sessions sham transcranial direct current stimulation (tDCS) Receives: Device: sham transcranial direct current stimulation |
| active tDCS | Experimental | 10 sessions active transcranial direct current stimulation (tDCS) Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating
Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome).
Measured: 8 weeks total
Pain Anxiety Symptom Scale Rating
The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety.
Measured: 8 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startNov 2014
- Primary completionApr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768129
- Sponsor's protocol ID
- 1411-003
- Status last verified
- Jul 2019
- First submitted
- 9 May 2016
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02768129
- Acronym / sponsor ID
- 1411-003
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS | Sham comparator | Device: sham transcranial direct current stimulation10 sessions sham transcranial direct current stimulation (tDCS) |
| active tDCS | Experimental | Device: transcranial direct current stimulation10 sessions active transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationactive stimulation: 2 milliamp (mA), 20 mins | Device | active tDCS |
| sham transcranial direct current stimulationsham stimulation | Device | sham tDCS |
Primary outcome
West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating
Time frame: 8 weeks total
Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome).
Pain Anxiety Symptom Scale Rating
Time frame: 8 weeks total
The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Chronic Low Back Pain, run by Butler Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating (time frame: 8 weeks total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.