Enhancing Inhibition With tDCS in Low Back Pain

Aalborg University12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Low Back Pain

Interventions

High-Definition Transcranial Direct Current StimulationDEVICE

Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

CNAP, SMI, Aalborg University

Aalborg, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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