An interventional study of High-Definition Transcranial Direct Current Stimulation in Low Back Pain, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Aalborg University · Not applicable, Interventional, and Basic science
This cross-over study intends to use consecutive days of active versus sham transcranial direct current stimulation (tDCS) to enhance descending inhibition and look at resulting clinical effects in people with low back pain.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA
Device: High-Definition Transcranial Direct Current Stimulation
30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes
Device: High-Definition Transcranial Direct Current Stimulation
Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.
Conditioned Pain Modulation
Change in cuff pain threshold with contralateral cuff conditioning stimulus
Time frame: Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Temporal Summation of Pain
Change in pain intensity ratings (i.e. on an electronic Visual Analogue Scale from 0=no pain to 10=worst pain imaginable) across series of 10 x 1s cuff stimuli at 0.5Hz (scores are normalized to first rating by subtraction and grouped into 3 epochs of 3 inflations with higher change scores indicating higher summation/facilitation)
Time frame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Pressure Pain Thresholds
Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles
Time frame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Pain Intensity
Visual Analogue Scale from 0=no pain to 10=worst pain imaginable currently at rest and with worst movement, as well as maximum in past week
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Pain Unpleasantness
Visual Analogue Scale from 0=not unpleasant at all to 10=most unpleasant sensation imaginable currently at rest and with worst movement, as well as maximum in past week
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Pain Area
Total number of pixels coloured on an electronic body chart (Navigate Pain)
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Roland-Morris Disability Questionnaire
Measures back-related disability for 24 statements of potentially afflicted tasks with dichotomous responses. Minimum 0 to maximum 24 with higher scores indicating worse disability.
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Back Performance Scale
5 Task scale rated as per performance as a functional measure of back-related disability (each task is rated on a 4 point Likert scale 0-3 and summed to give total), scored from 0-15 with higher scores indicating more pain and dysfunction during task performance. Here will be used to characterize functional disability.
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Flanker Task Learning
Reaction time to selective attention based computer task
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Affect Manipulation
Effect of image watching on ratings of mood and arousal. Mood and arousal will be measured with the Self Assessment Manikin - a 9 point Likert-type scale with 1 representing most negative/most calm, 5 as neutral, and 9 as most positive/most aroused.
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Plan to share: Undecided — Data will be shared after study completion and publication in necessary cases on request
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Aalborg University