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Completed

NCT Number: NCT03864822

Enhancing Inhibition With tDCS in Low Back Pain

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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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CNAP, SMI, Aalborg University

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Conditioned Pain Modulation

    Time frame: Day 0 (Pre) to Day 3 (Post) in each stimulation phase

    Change in cuff pain threshold with contralateral cuff conditioning stimulus

Secondary outcomes

  1. Temporal Summation of Pain

    Time frame: 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)

  2. Pressure Pain Thresholds

    Time frame: 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

  3. Pain Intensity

    Time frame: 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

  4. Pain Unpleasantness

    Time frame: 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

  5. Pain Area

    Time frame: 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)

  6. Roland-Morris Disability Questionnaire

    Time frame: 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.

  7. Back Performance Scale

    Time frame: 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.

Other outcomes

  1. Flanker Task Learning

    Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase

    Reaction time to selective attention based computer task

  2. Affect Manipulation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Danish National Research Foundation

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2019
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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