Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain

Summary

Low back pain (LBP) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. A multimodal approach to pain management, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES), may improve outcomes in chronic LBP. However, the optimal cerebral target for stimulation still remains controversial. This pilot trial aims to investigate whether active stimulation could promote additional gains to the PES results in LBP participants. The secondary objective is to investigate whether the stimulation of primary motor cortex and dorsolateral prefrontal cortex results in distinct clinical effects for the participants involved.

Conditions

• Chronic Pain
• Low Back Pain

Interventions

DEVICE

Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation

Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The participants will be positioned in ventral decubitus position. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on C3 to stimulate the left primary motor cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).

DEVICE

Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation

Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on F3 to stimulate the left dorsolateral cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).

DEVICE

Sham tDCS and PES

For sham tDCS and PES stimulation, patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes. The anodic electrode will be positioned on the left primary motor cortex, but the current will be turned off automatically after 30 seconds. The reference electrode will be positioned in the supra orbital contralateral region. For sham PES stimulations, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed), but the current will be turned off automatically after 30 seconds.

Sponsors & Collaborators

• Federal University of Paraíba

  lead OTHER

Principal Investigators

• Suellen Andrade · Federal University of Paraiba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2021-05-31

Completion

2021-08-31