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| Name | Class |
|---|---|
| Danish National Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | 30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA |
|
| Sham tDCS | Placebo Comparator | 30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Definition Transcranial Direct Current Stimulation | Device | Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conditioned Pain Modulation | Change in cuff pain threshold with contralateral cuff conditioning stimulus | Day 0 (Pre) to Day 3 (Post) in each stimulation phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 (Pre) to Day 3 (Post) in each stimulation phase |
| Measure | Description | Time Frame |
|---|---|---|
| Flanker Task Learning | Reaction time to selective attention based computer task | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan E McPhee, BPhty MSc | Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNAP, SMI, Aalborg University | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33676009 | Derived | McPhee ME, Graven-Nielsen T. Medial Prefrontal High-Definition Transcranial Direct Current Stimulation to Improve Pain Modulation in Chronic Low Back Pain: A Pilot Randomized Double-blinded Placebo-Controlled Crossover Trial. J Pain. 2021 Aug;22(8):952-967. doi: 10.1016/j.jpain.2021.02.012. Epub 2021 Mar 4. |
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Data will be shared after study completion and publication in necessary cases on request
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Stimulation type will be randomized by a colleague not involved in the study. A single investigator will assess all outcomes on all participants before and after each phase of stimulation, but participants not the investigator will be aware of Active/Sham assignment until after study completion
| Pressure Pain Thresholds | Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles | 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 | 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 | 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) | 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. | 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. | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase |
| Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase |
| D013568 |
| Pathological Conditions, Signs and Symptoms |