Low Back Pain
Conditions
Brief summary
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.
Interventions
Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.
Sponsors
Danish National Research Foundation
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Otherwise healthy men and women * Aged 18-60 years * Continuous pain (\>3days pain/week) episode lasting at least 3 months, sufficient to limit daily activities * Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at the time of recruitment * Able to speak, read and understand English
Exclusion criteria
* Pregnancy * Low back pain associated with menstruation * Currently seeking active treatment for low back pain * Red flags symptoms (i.e. fever, malaise, progressive neurologic deficit, significant trauma, prolonged corticosteroid use or osteoporosis, pain worst at night, urinary or faecal incontinence, or unintended weight loss) * Drug addiction defined as the use of cannabis, opioids or other drugs * Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial * Current or previous chronic or recurrent pain condition other than low back pain * Current regular use of analgesic medication or other medication which may affect the trial * Lack of ability to cooperate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conditioned Pain Modulation | Day 0 (Pre) to Day 3 (Post) in each stimulation phase | Change in cuff pain threshold with contralateral cuff conditioning stimulus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temporal Summation of Pain | Day 1 (Pre) to Day 3 (Post) in each stimulation phase | 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) |
| Pressure Pain Thresholds | Day 1 (Pre) to Day 3 (Post) in each stimulation phase | Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles |
| Pain Intensity | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | 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 |
| Pain Unpleasantness | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | 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 |
| Roland-Morris Disability Questionnaire | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | 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. |
| Back Performance Scale | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | 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. |
| Pain Area | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | Total number of pixels coloured on an electronic body chart (Navigate Pain) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Flanker Task Learning | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | Reaction time to selective attention based computer task |
| Affect Manipulation | Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase | 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. |
Countries
Denmark
Outcome results
None listed