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| ID | Type | Description | Link |
|---|---|---|---|
| USaoPauloGH | Other Identifier | USaoPauloGH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Sham tDCS + Sham TENS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be evaluated by numerical rating scale (0-10). | Four weeks after randomization |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Visual analogue scale (VAS)for anxiety assesses anxiety symptoms that we tracked as possible confounding factor. | 4 weeks, 3 and 6 months after randomization. |
| Depression | Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fuad A Hazime, PT | University of Sao Paulo | Principal Investigator |
| Silvia MA João, PT | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Physiotherapy - University of São Paulo | São Paulo | São Paulo | 05360-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25636503 | Derived | 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. |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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. |
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| Transcutaneous electrical nerve stimulation (TENS) | Procedure | Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area. |
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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 |
| 4 weeks, 3 and 6 months after randomization |
| Satisfaction with care | Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care. | 4 weeks after randomization |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |