search
Back to results

Enhancing Inhibition With tDCS in Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High-Definition Transcranial Direct Current Stimulation
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CNAP, SMI, Aalborg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA

30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes

Outcomes

Primary Outcome Measures

Conditioned Pain Modulation
Change in cuff pain threshold with contralateral cuff conditioning stimulus

Secondary Outcome Measures

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)
Pressure Pain Thresholds
Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles
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
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
Pain Area
Total number of pixels coloured on an electronic body chart (Navigate Pain)
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.
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.

Full Information

First Posted
March 1, 2019
Last Updated
December 10, 2020
Sponsor
Aalborg University
Collaborators
Danish National Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT03864822
Brief Title
Enhancing Inhibition With tDCS in Low Back Pain
Official Title
Enhancing Inhibition With tDCS in Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Danish National Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes
Intervention Type
Device
Intervention Name(s)
High-Definition Transcranial Direct Current Stimulation
Intervention Description
Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.
Primary Outcome Measure Information:
Title
Conditioned Pain Modulation
Description
Change in cuff pain threshold with contralateral cuff conditioning stimulus
Time Frame
Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Secondary Outcome Measure Information:
Title
Temporal Summation of Pain
Description
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
Title
Pressure Pain Thresholds
Description
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
Title
Pain Intensity
Description
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
Title
Pain Unpleasantness
Description
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
Title
Pain Area
Description
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
Title
Roland-Morris Disability Questionnaire
Description
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.
Time Frame
Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Title
Back Performance Scale
Description
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.
Time Frame
Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Other Pre-specified Outcome Measures:
Title
Flanker Task Learning
Description
Reaction time to selective attention based computer task
Time Frame
Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Title
Affect Manipulation
Description
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.
Time Frame
Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan E McPhee, BPhty MSc
Organizational Affiliation
Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CNAP, SMI, Aalborg University
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared after study completion and publication in necessary cases on request
Citations:
PubMed Identifier
33676009
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.
Results Reference
derived

Learn more about this trial

Enhancing Inhibition With tDCS in Low Back Pain

We'll reach out to this number within 24 hrs