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

Phase 2

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS)

• Registration Number: NCT01896453
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-11
• Status Verified: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
tDCS real + TENS sham	Transcutaneous electrical nerve stimulation (TENS)	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.
tDCS real + TENS real	Transcranial direct current stimulation (tDCS)	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.
tDCS real + TENS sham	Transcranial direct current stimulation (tDCS)	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.
tDCS sham + TENS real	Transcranial direct current stimulation (tDCS)	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.
Sham tDCS + Sham TENS	Transcutaneous electrical nerve stimulation (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.
tDCS real + TENS real	Transcutaneous electrical nerve stimulation (TENS)	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.
tDCS sham + TENS real	Transcutaneous electrical nerve stimulation (TENS)	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.
Sham tDCS + Sham TENS	Transcranial direct current stimulation (tDCS)	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Four weeks after randomization	Pain intensity will be evaluated by numerical rating scale (0-10).

Secondary Outcome Measures

Name	Time	Method
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.
Pain intensity	3 and 6 months after randomization	Pain intensity will be evaluated by numerical rating scale (0-10)
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.

Trial Locations

Locations (1)

School of Physiotherapy - University of São Paulo; 🇧🇷 São Paulo, Brazil