NCT03864822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

March 1, 2019

Last Update Submit

December 10, 2020

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Temporal Summation of Pain

    Day 1 (Pre) to Day 3 (Post) in each stimulation phase

  • Pressure Pain Thresholds

    Day 1 (Pre) to Day 3 (Post) in each stimulation phase

  • Pain Intensity

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

  • Pain Unpleasantness

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

  • Pain Area

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

  • +2 more secondary outcomes

Other Outcomes (2)

  • Flanker Task Learning

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

  • Affect Manipulation

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

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Device: High-Definition Transcranial Direct Current Stimulation

Sham tDCS

PLACEBO COMPARATOR

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

Device: High-Definition Transcranial Direct Current Stimulation

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.

Active tDCSSham tDCS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNAP, SMI, Aalborg University

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 33676009DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Megan E McPhee, BPhty MSc

    Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 6, 2019

Study Start

April 29, 2019

Primary Completion

October 7, 2020

Study Completion

October 7, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations

DK(1)