Clinical trial NCT03864822: Enhancing Inhibition With tDCS in Low Back Pain
Official title: Enhancing Inhibition With tDCS in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Danish National Research Foundation
First posted: 2019-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Conditioned Pain Modulation
timeFrame: Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Secondary outcomes:
measure: Temporal Summation of Pain
timeFrame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
measure: Pressure Pain Thresholds
timeFrame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
measure: Pain Intensity
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
measure: Pain Unpleasantness
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
measure: Pain Area
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
measure: Roland-Morris Disability Questionnaire
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
measure: Back Performance Scale
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Other outcomes:
measure: Flanker Task Learning
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
measure: Affect Manipulation
timeFrame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Locations:
city: Aalborg
country: Denmark
facility: CNAP, SMI, Aalborg University
Study officials:
affiliation: Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University
name: Megan E McPhee, BPhty MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.