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Enhancing Inhibition With tDCS in Low Back Pain

NCT ID: NCT03864822

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2020-10-07

Brief Summary

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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

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

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Active tDCS

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

Group Type EXPERIMENTAL

High-Definition Transcranial Direct Current Stimulation

Intervention Type DEVICE

Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.

Sham tDCS

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

Group Type PLACEBO_COMPARATOR

High-Definition Transcranial Direct Current Stimulation

Intervention Type DEVICE

Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish National Research Foundation

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Megan McPhee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Megan E McPhee, BPhty MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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CNAP, SMI, Aalborg University

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33676009 (View on PubMed)

Other Identifiers

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VN-20170034-v5

Identifier Type: -

Identifier Source: org_study_id