Enhancing Inhibition With tDCS in Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Device: High-Definition Transcranial Direct Current Stimulation

• Registration Number: NCT03864822
• Lead Sponsor: Aalborg University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Study Start: 2019-04-29
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active tDCS	High-Definition Transcranial Direct Current Stimulation	30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA
Sham tDCS	High-Definition Transcranial Direct Current Stimulation	30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes

Primary Outcome Measures

Name	Time	Method
Conditioned Pain Modulation	Day 0 (Pre) to Day 3 (Post) in each stimulation phase	Change in cuff pain threshold with contralateral cuff conditioning stimulus

Secondary Outcome Measures

Name	Time	Method
Temporal Summation of Pain	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)
Pressure Pain Thresholds	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
Pain Intensity	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
Pain Unpleasantness	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
Pain Area	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)
Roland-Morris Disability Questionnaire	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.
Back Performance Scale	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.

Trial Locations

Locations (1)

CNAP, SMI, Aalborg University; 🇩🇰 Aalborg, Denmark