Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.

Official Title
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Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Procedure: Transcranial direct current stimulation (tDCS)
* Procedure: Transcutaneous electrical nerve stimulation (TENS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tDCS real + TENS real<br>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. | Procedure: Transcranial direct current stimulation (tDCS)<br>* 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<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.<br>|
| Experimental: tDCS real + TENS sham<br>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. | Procedure: Transcranial direct current stimulation (tDCS)<br>* 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<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.<br>|
| Experimental: tDCS sham + TENS real<br>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. | Procedure: Transcranial direct current stimulation (tDCS)<br>* 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<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.<br>|
| Sham Comparator: Sham tDCS + Sham TENS<br>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. | Procedure: Transcranial direct current stimulation (tDCS)<br>* 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<br>Procedure: Transcutaneous electrical nerve stimulation (TENS)<br>* Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be evaluated by numerical rating scale (0-10). | Four weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain. | 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. | 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. | 4 weeks, 3 and 6 months after randomization. | 
| Pain intensity | Pain intensity will be evaluated by numerical rating scale (0-10) | 3 and 6 months after randomization |