Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
NCT ID: NCT01896453
Last Updated: 2014-12-04
Study Results
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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COMPLETED
PHASE2/PHASE3
92 participants
INTERVENTIONAL
2013-06-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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tDCS real + TENS real
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.
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
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.
tDCS real + TENS sham
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.
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
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.
tDCS sham + TENS real
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.
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
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.
Sham tDCS + Sham 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.
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Fuad A Hazime, PT
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Silvia MA João, PT
Role: STUDY_CHAIR
University of Sao Paulo
Locations
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School of Physiotherapy - University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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USaoPauloGH
Identifier Type: OTHER
Identifier Source: secondary_id
tDCSBACKPAIN
Identifier Type: -
Identifier Source: org_study_id