Chronic Low Back PainPhase 2/3NCT02483468
The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
A Phase 2/3 study testing Cognitive Behavioral Therapy for Pain and Transcranial Direct Current Stimulation in people with Chronic Low Back Pain and Opioid Use, Unspecified, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g.… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain, Opioid Use, Unspecified
- What is being tested?
- Cognitive Behavioral Therapy for Pain and Transcranial Direct Current Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 28 Apr 2021
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 70.
- United States Veteran or family member of a Veteran.
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
- Subjects must be able to comprehend English.
- Have a chronic pain condition and ≥3months duration of pain.
- BPI score >4/10.
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- Meet DSM-5 criteria for current (i.e., past 6 months) prescription opioid use disorder (assessed via the MINI 7.0).
- COMM score>7.
- Subjects may also meet criteria for a mood disorder if asymptomatic or anxiety disorders (PTSD, panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with chronic pain and prescription opioid use disorders.
- Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
- Must consent to random assignment to CBT + tDCS or CBT + sham tDCS.
- Must consent to complete all treatment and follow-up visits.
- Must live within 100 miles of the Medical University of South Carolina.
Who cannot join
- Subjects with symptomatic psychotic/bipolar disorder and/or deemed too high risk by the study physician
- Subjects with current suicidal or homicidal ideation and intent.
- Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy in addition to the proposed therapy for stabilization.
- Subjects who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.
- Subjects enrolled in ongoing behavioral therapy for pain or substance use disorders, who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.
- Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks. If it is determined, based on clinical criteria, that a subject needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the course of the study, they will be discontinued from the treatment trial.
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- Subjects with organic mental syndrome.
- Pregnant women.
- History of seizures.
- Implanted medical devices above the waist.
- Latex allergy.
- Diagnosis of Fibromyalgia.
- History of eczema or other sensitive skin conditions.
- Known brain tumors or lesions that intersect the area of stimulation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity.
Read the detailed description
As a result of sustained operations in Afghanistan and Iraq, an increasing number of U.S. military personnel and Veterans are in need of effective pain management treatment. Chronic low back pain (CLBP) is the most common pain condition among returning Veterans and is associated with high levels of opioid analgesic prescribing in VA clinics. Although opioids are effective for acute pain, they are not very effective as a long-term treatment strategy. Furthermore, opioids are associated with significantly increased risk of misuse, addiction, diversion, overdose and death. Consequently, there is a critical need for the development of alternative, effective treatments for CLBP that can be implemented in VA-based healthcare settings. The proposed study will answer critical questions regarding the ability of Transcranial Direct Current Stimulation (tDCS) to augment the effects of cognitive behavioral therapy (CBT) for pain, and elucidate possible mechanisms underlying improved outcomes. tDCS is inexpensive and highly portable, making it a very scalable tool to add to current CBT interventions within the VA healthcare system. This study has the particular advantages of building directly on positive preliminary findings among civilians and is being led by a multi-disciplinary team of experts who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The primary objective of the proposed Stage II study is to evaluate the effects of CBT in combination with tDCS in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity. Secondary objectives are to evaluate acute lab-based pain markers and neural correlates of improvement in chronic pain using quantitative sensory testing. In order to accomplish this the investigators are: using a manualized, evidence-based CBT intervention that is already widely-disseminated within the VA system; employing a randomized, between-groups, double-blind experimental design; and examining standardized, repeated, dependent measures of change in: (a) clinical outcomes such as pain, opioid and other substance use disorders (e.g., alcohol, illicit drugs, other prescription drugs), depression, anxiety, sleep and PTSD symptomatology; and (b) process variables such as participant satisfaction, quality of life and treatment retention. The results of this study will provide important information regarding two non-pharmacologic, evidence-based interventions (CBT and tDCS), and will help inform policies and programs to better serve the needs of U.S. military personnel, Veterans, and their families. The findings from this study may help reduce public health costs and morbidity/mortality associated with chronic pain and co-morbid prescription opiate use disorders among our nation's Veterans.
- Conditions
- Chronic Low Back Pain, Opioid Use, Unspecified
- Being tested
- Cognitive Behavioral Therapy for Pain, 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.
Cognitive Behavioral Therapy for PainBehavioural
Also called CBT
Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities.
Transcranial Direct Current StimulationDevice
Also called tDCS
Electrical stimulation of the prefrontal cortex using 2mA of direct current
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
Sham stimulation of the left dorsolateral prefrontal cortex
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current Receives: Behavioral: Cognitive Behavioral Therapy for Pain; Device: Transcranial Direct Current Stimulation |
| tDCS (sham) | Sham comparator | Inactive (sham) Transcranial Direct Current Stimulation Receives: Behavioral: Cognitive Behavioral Therapy for Pain; Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Pain
Average daily pain defined by item #5 on the Brief Pain Inventory (BPI). Scale on scale of 0-10; anchored with "0-no pain" and "10- pain as bad as you can imagine."
Measured: 3 months
Pain Interference
Pain interference defined by the mean of items 9.a ---9.i; the measure is scored on a scale of 0--10, anchored by "0-does not interfere" and "10- completely interferes"
Measured: 3 months
Pain Catastrophizing
Pain catastrophizing defined by total score of 13 items pain catastrophizing scale. This measure has a total score range of 0-52 where for each item is anchored by "0-not at all" and "4-all the time." Larger total score indicates more catastrophizing.
Measured: 3 months
Secondary outcomes (5)
Opioid Misuse
Current Opioid Misuse Measure scores. 17-item Likert-type scale (For each opioid misuse risk behavior item, 0="Never and 4="Very often"). Possible range is 0 to 68. Higher scores indicate more opioid misuse concerns.
Measured: 3 months
Psychiatric Functioning (Depression)
Depression: Beck Depression Inventory-II (BDI-II): The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Possible range is 0 to 63 points. Higher scores mean more depression symptoms.
Measured: 3 months
Psychiatric Functioning (Anxiety)
Beck Anxiety Inventory (BAI): 21-item self-report inventory used to assess anxiety levels in adults and adolescents. The score range is 0-63. Higher scores mean more anxiety symptoms.
Measured: 3 Months
Psychiatric Functioning (PTSD)
PTSD Checklist (PCL) 20-item self-report measure of the DSM-5 symptoms of PTSD: Score range: 0-80. Higher scores mean more post-traumatic stress symptoms.
Measured: 3 Months
Psychiatric Functioning (Sleep)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated. questionnaire which assesses sleep quality and disturbances. Range of scores: 0-21. Higher scores mean more sleep disturbance.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startAug 2015
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
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.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Borckardt, Medical University of South Carolina
- Investigators
- Jeffrey J Borckardt, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483468
- Sponsor's protocol ID
- Pro00036590
- Status last verified
- Jan 2023
- First submitted
- 12 Jun 2015
- Last updated
- 10 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT02483468
- Acronym / sponsor ID
- Pro00036590
- Conditions
- Chronic Low Back Pain, Opioid Use, Unspecified
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 10 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effects of cognitive-behavioral therapy in combination with transcranial direct current stimulation in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity.
Detailed description
As a result of sustained operations in Afghanistan and Iraq, an increasing number of U.S. military personnel and Veterans are in need of effective pain management treatment. Chronic low back pain (CLBP) is the most common pain condition among returning Veterans and is associated with high levels of opioid analgesic prescribing in VA clinics. Although opioids are effective for acute pain, they are not very effective as a long-term treatment strategy. Furthermore, opioids are associated with significantly increased risk of misuse, addiction, diversion, overdose and death. Consequently, there is a critical need for the development of alternative, effective treatments for CLBP that can be implemented in VA-based healthcare settings. The proposed study will answer critical questions regarding the ability of Transcranial Direct Current Stimulation (tDCS) to augment the effects of cognitive behavioral therapy (CBT) for pain, and elucidate possible mechanisms underlying improved outcomes. tDCS is inexpensive and highly portable, making it a very scalable tool to add to current CBT interventions within the VA healthcare system. This study has the particular advantages of building directly on positive preliminary findings among civilians and is being led by a multi-disciplinary team of experts who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The primary objective of the proposed Stage II study is to evaluate the effects of CBT in combination with tDCS in (1) improving pain and functionality, (2) reducing severity of opioid use disorders, and (3) reducing impairment in associated mental health areas (e.g., depression, anxiety, PTSD, sleep). The investigators will also determine the effects of treatment on neural activity in cognitive and limbic brain regions involved in pain regulation using functional magnetic resonance imaging (fMRI), and examine its relationship to opioid use severity. Secondary objectives are to evaluate acute lab-based pain markers and neural correlates of improvement in chronic pain using quantitative sensory testing. In order to accomplish this the investigators are: using a manualized, evidence-based CBT intervention that is already widely-disseminated within the VA system; employing a randomized, between-groups, double-blind experimental design; and examining standardized, repeated, dependent measures of change in: (a) clinical outcomes such as pain, opioid and other substance use disorders (e.g., alcohol, illicit drugs, other prescription drugs), depression, anxiety, sleep and PTSD symptomatology; and (b) process variables such as participant satisfaction, quality of life and treatment retention. The results of this study will provide important information regarding two non-pharmacologic, evidence-based interventions (CBT and tDCS), and will help inform policies and programs to better serve the needs of U.S. military personnel, Veterans, and their families. The findings from this study may help reduce public health costs and morbidity/mortality associated with chronic pain and co-morbid prescription opiate use disorders among our nation's Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Behavioral: Cognitive Behavioral Therapy for Pain, Device: Transcranial Direct Current StimulationActive Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current |
| tDCS (sham) | Sham comparator | Behavioral: Cognitive Behavioral Therapy for Pain, Device: Sham Transcranial Direct Current StimulationInactive (sham) Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ages 18 to 70.
- United States Veteran or family member of a Veteran.
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
- Subjects must be able to comprehend English.
- Have a chronic pain condition and ≥3months duration of pain.
Key exclusion criteria (14 listed)
- Subjects with symptomatic psychotic/bipolar disorder and/or deemed too high risk by the study physician
- Subjects with current suicidal or homicidal ideation and intent.
- Subjects with a current eating disorder (bulimia, anorexia nervosa) or with dissociative identity disorder, as they are likely to require specific time-intensive psychotherapy in addition to the proposed therapy for stabilization.
- Subjects who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.
- Subjects enrolled in ongoing behavioral therapy for pain or substance use disorders, who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.
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 |
|---|---|---|
| Cognitive Behavioral Therapy for PainAlso: CBTCognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities. | Behavioural | tDCS, tDCS (sham) |
| Transcranial Direct Current StimulationAlso: tDCSElectrical stimulation of the prefrontal cortex using 2mA of direct current | Device | tDCS |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSSham stimulation of the left dorsolateral prefrontal cortex | Device | tDCS (sham) |
Primary outcome
Average Daily Pain
Time frame: 3 months
Average daily pain defined by item #5 on the Brief Pain Inventory (BPI). Scale on scale of 0-10; anchored with "0-no pain" and "10- pain as bad as you can imagine."
Pain Interference
Time frame: 3 months
Pain interference defined by the mean of items 9.a ---9.i; the measure is scored on a scale of 0--10, anchored by "0-does not interfere" and "10- completely interferes"
Pain Catastrophizing
Time frame: 3 months
Pain catastrophizing defined by total score of 13 items pain catastrophizing scale. This measure has a total score range of 0-52 where for each item is anchored by "0-not at all" and "4-all the time." Larger total score indicates more catastrophizing.
5 secondary outcomes
Opioid Misuse
Time frame: 3 months
Psychiatric Functioning (Depression)
Time frame: 3 months
Psychiatric Functioning (Anxiety)
Time frame: 3 Months
Psychiatric Functioning (PTSD)
Time frame: 3 Months
Psychiatric Functioning (Sleep)
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- 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.
Jeffrey J Borckardt, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Behavioral Therapy for Pain and Transcranial Direct Current Stimulation in people with Chronic Low Back Pain and Opioid Use, Unspecified, run by Medical University of South Carolina at 1 site in United States.
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 13 inclusion and 14 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2023). 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?
Average Daily Pain (time frame: 3 months). The study lists 3 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 10 Feb 2023.