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

Federal University of Paraíba

Status: Unknown

Conditions: Chronic Pain; Low Back Pain

Treatments: Device: Sham tDCS and PES; Device: Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation; Device: Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04496661

Painmodulation

Details and patient eligibility

About

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.

Full description

For this, a pilot, sham-controlled, double-blind, randomized clinical trial in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Sixty participants with chronic low back pain will be randomized into one of three tDCS groups associated with PES: motor primary cortex, dorsolateral prefrontal cortex and sham stimulation. Each group will receive transcranial direct current stimulation at an intensity of 2 mA for 30 minutes daily for 10 consecutive days. Participants will be assessed with a Brief Pain Inventory (BPI), Roland Morris Disability Questionnaire (RMDQ), Medical Outcomes Study 36-item Short - Form Health Survey (SF-36) and electromyography at baseline, endpoint (after 10 sessions) and 1-month follow up. This study will help to clarify the additive effects of tDCS combined with peripheral electrical stimulation on pain relief, muscle function and improvement in quality of life. Additionally, the investigators will provide data to identify optimal targets for management of chronic low back pain.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years;
• Diagnosis of chronic low back pain, lasting more than 6 months (The diagnosis of chronic lumbar pain will be based on clinical and neurophysiological criteria, according to the European Guidelines on Low Back Pain);
• Pain intensity of at least 4 in 10 in Visual Analogue Scale (VAS);
• Stable pharmacological treatment for at least one month before the study and throughout the study;

Exclusion criteria

• Intense pain from another origin, such as neuropathic pain;
• Alcohol or substance abuse;
• Associated diseases of the peripheral or central nervous system;
• Contraindications for non-invasive brain stimulation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

tDCS over M1 and PES

Experimental group

Description:

Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation

tDCS over DLPFC and PES

Experimental group

Description:

Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes.

Treatment:

Device: Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation

Sham tDCS and PES

Sham Comparator group

Description:

Sham tDCS and PES stimulation. Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. The currents will be turned off automatically after 30 seconds. Duration: 30 minutes.

Treatment:

Device: Sham tDCS and PES