Low Back PainNCT03864822
Enhancing Inhibition With tDCS in Low Back Pain
A study testing High-Definition Transcranial Direct Current Stimulation in people with Low Back Pain, run by Aalborg University at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- High-Definition Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Apr 2019to 7 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- High-Definition Transcranial Direct Current Stimulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | 30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA Receives: 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 Receives: Device: High-Definition Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
Change in cuff pain threshold with contralateral cuff conditioning stimulus
Measured: Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Secondary outcomes (7)
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)
Measured: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Pressure Pain Thresholds
Handheld algometry over the extensor carpi radialis, upper trapezius, lower back and gastrocnemius muscles
Measured: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
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
Measured: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
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
Measured: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Pain Area
Total number of pixels coloured on an electronic body chart (Navigate Pain)
Measured: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
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.
Measured: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
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.
Measured: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start29 Apr 2019
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Danish National Research Foundation
- Responsible party
- Principal investigator, Megan McPhee, Aalborg University
- Investigators
- Megan E McPhee, BPhty MSc, Principal investigator, Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864822
- Sponsor's protocol ID
- VN-20170034-v5
- Status last verified
- Dec 2020
- First submitted
- 1 Mar 2019
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared after study completion and publication in necessary cases on request
Publications
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.
PubMed 33676009
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Inhibition With tDCS in Low Back Pain
- ClinicalTrials.gov ID
- NCT03864822
- Acronym / sponsor ID
- VN-20170034-v5
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Danish National Research Foundation
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: High-Definition Transcranial Direct Current Stimulation30s ramp to 2mA with 20 minute session of active High-Definition Transcranial Direct Current Stimulation at 2mA |
| Sham tDCS | Placebo comparator | Device: High-Definition Transcranial Direct Current Stimulation30s ramp to 2mA with High-Definition Transcranial Direct Current Stimulation, then device stops stimulating for 20 minutes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Definition Transcranial Direct Current StimulationDevice uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current. | Device | Active tDCS, Sham tDCS |
Primary outcome
Conditioned Pain Modulation
Time frame: Day 0 (Pre) to Day 3 (Post) in each stimulation phase
Change in cuff pain threshold with contralateral cuff conditioning stimulus
7 secondary outcomes
Temporal Summation of Pain
Time frame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Pressure Pain Thresholds
Time frame: Day 1 (Pre) to Day 3 (Post) in each stimulation phase
Pain Intensity
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Pain Unpleasantness
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Pain Area
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Roland-Morris Disability Questionnaire
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Back Performance Scale
Time frame: Day 0 (Pre) to Day 3 (Post) and 2 weeks post for each stimulation phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 33676009McPhee 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.
- Individual participant dataSharing planned: Undecided. Data will be shared after study completion and publication in necessary cases on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan E McPhee, BPhty MSc principal investigator
Center for Neuroplasticity and Pain (CNAP), SMI, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Definition Transcranial Direct Current Stimulation in people with Low Back Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Pain Modulation (time frame: Day 0 (Pre) to Day 3 (Post) in each stimulation phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.