Chronic Low Back PainPhase 2/3NCT01896453
Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
A Phase 2/3 study testing Transcranial direct current stimulation (tDCS) and Transcutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged > 18 years and <65 years
- Complaining of back pain for more than three months
- Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
- Seeking care for low back pain
Who cannot join
- Previous surgery on the spine, spondylolisthesis
- Previous treatment with TENS <6 months
- Previous treatment with tDCS
- Disc herniation with nerve compression
- Neurological, psychiatric and rheumatologic diseases
- Impaired sensibility
- Use of pacemakers or other implanted devices
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Physiotherapy - University of São Paulo
São Paulo, São Paulo, 05360-000
About this study
Official title: Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.
- Conditions
- Chronic Low Back Pain
- Being tested
- Transcranial direct current stimulation (tDCS), Transcutaneous electrical nerve stimulation (TENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Procedure or surgery
Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively
Transcutaneous electrical nerve stimulation (TENS)Procedure or surgery
Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.
| Study group | Role | What they receive |
|---|---|---|
| tDCS real + TENS real | Active comparator | Real transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. Receives: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS) |
| tDCS real + TENS sham | Experimental | Real transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. Receives: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS) |
| tDCS sham + TENS real | Experimental | Sham transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. Receives: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS) |
| Sham tDCS + Sham TENS | Sham comparator | Sham transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS).
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. Receives: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be evaluated by numerical rating scale (0-10).
Measured: Four weeks after randomization
Secondary outcomes (4)
Disability
The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.
Measured: 4 weeks, 3 and 6 months after randomization.
Quality of pain
The Short form of the McGill pain questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard long form. The 6 point intensity scale and a VAS are included to provide indices of overall pain intensity.
Measured: 4 weeks, 3 and 6 months after randomization.
Global perceived effect (GPE)
Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered). For all measures of global perceived effect (at baseline and all follow-ups), participants were asked compared to when this episode first started, how would you describe your back these days. A higher score indicates higher recovery from the condition.
Measured: 4 weeks, 3 and 6 months after randomization.
Pain intensity
Pain intensity will be evaluated by numerical rating scale (0-10)
Measured: 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Chronic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad A Hazime, PT, Principal investigator, University of Sao PauloSilvia MA João, PT, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896453
- Sponsor's protocol ID
- tDCSBACKPAIN
- Other IDs
- USaoPauloGH
- Status last verified
- Oct 2013
- First submitted
- 19 Jun 2013
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
PubMed 25636503
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01896453
- Acronym / sponsor ID
- tDCSBACKPAIN
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS real + TENS real | Active comparator | Procedure: Transcranial direct current stimulation (tDCS), Procedure: Transcutaneous electrical nerve stimulation (TENS)Real transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. |
| tDCS real + TENS sham | Experimental | Procedure: Transcranial direct current stimulation (tDCS), Procedure: Transcutaneous electrical nerve stimulation (TENS)Real transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. |
| tDCS sham + TENS real | Experimental | Procedure: Transcranial direct current stimulation (tDCS), Procedure: Transcutaneous electrical nerve stimulation (TENS)Sham transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. |
| Sham tDCS + Sham TENS | Sham comparator | Procedure: Transcranial direct current stimulation (tDCS), Procedure: Transcutaneous electrical nerve stimulation (TENS)Sham transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females aged > 18 years and <65 years
- Complaining of back pain for more than three months
- Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
- Seeking care for low back pain
Key exclusion criteria (8 listed)
- Previous surgery on the spine, spondylolisthesis
- Previous treatment with TENS <6 months
- Previous treatment with tDCS
- Disc herniation with nerve compression
- Neurological, psychiatric and rheumatologic diseases
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively | Procedure or surgery | Sham tDCS + Sham TENS, tDCS real + TENS real, tDCS real + TENS sham, tDCS sham + TENS real |
| Transcutaneous electrical nerve stimulation (TENS)Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area. | Procedure or surgery | Sham tDCS + Sham TENS, tDCS real + TENS real, tDCS real + TENS sham, tDCS sham + TENS real |
Primary outcome
Pain intensity
Time frame: Four weeks after randomization
Pain intensity will be evaluated by numerical rating scale (0-10).
4 secondary outcomes
Disability
Time frame: 4 weeks, 3 and 6 months after randomization.
Quality of pain
Time frame: 4 weeks, 3 and 6 months after randomization.
Global perceived effect (GPE)
Time frame: 4 weeks, 3 and 6 months after randomization.
Pain intensity
Time frame: 3 and 6 months after randomization
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 4 Dec 2014.
- Derived from this study: PubMed 25636503Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
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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.
Fuad A Hazime, PT principal investigator
University of Sao Paulo
Silvia MA João, PT study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Transcranial direct current stimulation (tDCS) and Transcutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 inclusion and 8 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 4 Dec 2014. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain intensity (time frame: Four weeks after randomization). 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 NCT01896453, 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 4 Dec 2014.