Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
2 other identifiers
interventional
92
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 4, 2014
October 1, 2013
1.5 years
June 19, 2013
December 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
Pain intensity will be evaluated by numerical rating scale (0-10).
Four weeks after randomization
Secondary Outcomes (4)
Disability
4 weeks, 3 and 6 months after randomization.
Quality of pain
4 weeks, 3 and 6 months after randomization.
Global perceived effect (GPE)
4 weeks, 3 and 6 months after randomization.
Pain intensity
3 and 6 months after randomization
Other Outcomes (3)
Anxiety
4 weeks, 3 and 6 months after randomization.
Depression
4 weeks, 3 and 6 months after randomization
Satisfaction with care
4 weeks after randomization
Study Arms (4)
tDCS real + TENS real
ACTIVE COMPARATORReal 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
EXPERIMENTALReal 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
EXPERIMENTALSham 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 COMPARATORSham 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.
Interventions
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
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Physiotherapy - University of São Paulo
São Paulo, São Paulo, 05360-000, Brazil
Related Publications (1)
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.
PMID: 25636503DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fuad A Hazime, PT
University of Sao Paulo
- STUDY CHAIR
Silvia MA João, PT
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2013
First Posted
July 11, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 4, 2014
Record last verified: 2013-10