Chronic Low Back Pain
Conditions
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.
Interventions
PROCEDURETranscranial 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
PROCEDURETranscutaneous 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.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Four weeks after randomization | Pain intensity will be evaluated by numerical rating scale (0-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of pain | 4 weeks, 3 and 6 months after randomization. | 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. |
| Disability | 4 weeks, 3 and 6 months after randomization. | The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain. |
| Global perceived effect (GPE) | 4 weeks, 3 and 6 months after randomization. | 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. |
| Pain intensity | 3 and 6 months after randomization | Pain intensity will be evaluated by numerical rating scale (0-10) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with care | 4 weeks after randomization | Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care. |
| Depression | 4 weeks, 3 and 6 months after randomization | Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor. |
| Anxiety | 4 weeks, 3 and 6 months after randomization. | Visual analogue scale (VAS)for anxiety assesses anxiety symptoms that we tracked as possible confounding factor. |
Countries
Brazil
Outcome results
None listed