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

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

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Procedure: Transcranial direct current stimulation (tDCS); Procedure: Transcutaneous electrical nerve stimulation (TENS)

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05360-000
    • School of Physiotherapy - University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: tDCS real + TENS real; 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); 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; Procedure: Transcutaneous 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.
EXPERIMENTAL: tDCS real + TENS sham; 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); 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; Procedure: Transcutaneous 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.
EXPERIMENTAL: tDCS sham + TENS real; 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); 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; Procedure: Transcutaneous 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.
SHAM_COMPARATOR: Sham tDCS + Sham 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.	Procedure: Transcranial 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; Procedure: Transcutaneous 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Fuad A Hazime, PT, University of Sao Paulo; Study Chair: Silvia MA João, PT, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (ESTIMATE): July 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: tDCSBACKPAIN; USaoPauloGH (USaoPauloGH)