Trial Outcomes & Findings for The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain (NCT NCT02483468)
NCT ID: NCT02483468
Last Updated: 2023-02-10
Results Overview
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."
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
160 participants
Primary outcome timeframe
3 months
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
tDCS (Active)
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
51
|
|
Overall Study
COMPLETED
|
46
|
30
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Cognitive Behavioral Therapy and Transcranial Current Stimulation (tDCS) on Chronic Lower Back Pain
Baseline characteristics by cohort
| Measure |
tDCS
n=65 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=51 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.03 years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
53.08 years
STANDARD_DEVIATION 10.84 • n=7 Participants
|
53.05 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsAverage 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."
Outcome measures
| Measure |
tDCS (Active)
n=46 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Average Daily Pain
|
5.41 score on a scale
Standard Error .33
|
5.96 score on a scale
Standard Error .38
|
PRIMARY outcome
Timeframe: 3 monthsPain 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"
Outcome measures
| Measure |
tDCS (Active)
n=46 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Pain Interference
|
5.00 score on a scale
Standard Error .39
|
5.30 score on a scale
Standard Error .44
|
PRIMARY outcome
Timeframe: 3 monthsPain 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.
Outcome measures
| Measure |
tDCS (Active)
n=46 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Pain Catastrophizing
|
20.58 score on a scale
Standard Error 2.14
|
18.11 score on a scale
Standard Error 2.55
|
SECONDARY outcome
Timeframe: 3 monthsCurrent 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.
Outcome measures
| Measure |
tDCS (Active)
n=46 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Opioid Misuse
|
10.76 score on a scale
Standard Deviation 9.82
|
9.80 score on a scale
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: 3 monthsDepression: 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.
Outcome measures
| Measure |
tDCS (Active)
n=47 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Psychiatric Functioning (Depression)
|
16.00 score on a scale
Standard Deviation 12.47
|
16.87 score on a scale
Standard Deviation 13.54
|
SECONDARY outcome
Timeframe: 3 MonthsBeck 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.
Outcome measures
| Measure |
tDCS (Active)
n=46 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=30 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Psychiatric Functioning (Anxiety)
|
15.88 score on a scale
Standard Deviation 12.94
|
16.38 score on a scale
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: 3 MonthsPTSD 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.
Outcome measures
| Measure |
tDCS (Active)
n=41 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=29 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Psychiatric Functioning (PTSD)
|
21.22 score on a scale
Standard Deviation 14.13
|
20.37 score on a scale
Standard Deviation 14.18
|
SECONDARY outcome
Timeframe: 3 MonthsThe 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.
Outcome measures
| Measure |
tDCS (Active)
n=8 Participants
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=13 Participants
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Psychiatric Functioning (Sleep)
|
10.75 score on a scale
Standard Deviation 5.8
|
11.23 score on a scale
Standard Deviation 3.94
|
Adverse Events
tDCS (Active)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
tDCS (Sham)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS (Active)
n=65 participants at risk
Active Transcranial Direct Current Stimulation - Stimulation of the left dorsolateral prefrontal cortex with 2mA of electrical current
Cognitive Behavioral Therapy for Pain: 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 Stimulation: Electrical stimulation of the prefrontal cortex using 2mA of direct current
|
tDCS (Sham)
n=51 participants at risk
Inactive (sham) Transcranial Direct Current Stimulation
Cognitive Behavioral Therapy for Pain: 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.
Sham Transcranial Direct Current Stimulation: Sham stimulation of the left dorsolateral prefrontal cortex
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation
|
1.5%
1/65 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
|
Social circumstances
Car accident
|
1.5%
1/65 • Number of events 1 • 6 months
|
0.00%
0/51 • 6 months
|
Additional Information
Jeffrey J Borckardt, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC & Medical University of South Carolina
Phone: 843.792.3295
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place