Enhancing Inhibition With tDCS in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Enhancing Inhibition With tDCS in Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864822
• Other study ID #: VN-20170034-v5
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: October 7, 2020

Study information

• Verified date: December 2020
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• High-Definition Transcranial Direct Current Stimulation
Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.

Locations

Country	Name	City	State
Denmark	CNAP, SMI, Aalborg University	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Danish National Research Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Flanker Task Learning	Reaction time to selective attention based computer task	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Other	Affect Manipulation	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.	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Primary	Conditioned Pain Modulation	Change in cuff pain threshold with contralateral cuff conditioning stimulus	Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Secondary	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)	Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Secondary	Pressure Pain Thresholds	Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles	Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Secondary	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	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Secondary	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	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Secondary	Pain Area	Total number of pixels coloured on an electronic body chart (Navigate Pain)	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Secondary	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.	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Secondary	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.	Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase