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

NCT04496661 | Unknown

• 1 other identifier: Painmodulation
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

PES; tDCS

Outcome Measures

Primary Outcomes (2)

• Change in pain severity

  Pain severity will be assessed with Numerical Rating Scales (NRS), which refers to a subjective measure in which individuals classify their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable).

  Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)

• Changes in pain interference in activities of daily living

  The Brief Pain Inventory (BPI) assesses multidimensional aspects of pain. It includes 15 items that evaluate the existence, severity, location, functional interference, applied therapeutic strategies and effectiveness of pain treatment. It is an instrument with adequate validity and reproducibility, commonly used in the evaluation of patients with chronic pain.

  Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)

Secondary Outcomes (3)

• Functional disability associated with chronic low back pain measured by Roland Morris Disability Questionnaire (RMDQ)

  Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)

• Quality of life (SF-36)

  Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)

• Electrical activity of lumbar/multifidus (ML) and transverse abdominal (TrA)

  Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)

Study Arms (3)

tDCS over M1 and PES

EXPERIMENTAL

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.

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

tDCS over DLPFC and PES

EXPERIMENTAL

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.

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

Sham tDCS and PES

SHAM COMPARATOR

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.

Device: Sham tDCS and PES

Interventions

Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation DEVICE

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).

tDCS over M1 and PES

Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation DEVICE

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).

tDCS over DLPFC and PES

Sham tDCS and PES DEVICE

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.

Sham tDCS and PES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Suellen Andrade

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen Andrade

CONTACT

+55 83 987772488; suellenandrade@gmail.com

Palloma Andrade

CONTACT

+5583993148319; pallomandrade@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly allocated via an online generator (www.random.org) in one of three groups (1:1:1): anodal tDCS of M1 + PES; anodal tDCS of DLPFC + PES; Sham of M1 + PES. This sequence will be performed blindly, independently, and remotely by a blind investigator who will have no contact with other research procedures, and randomization will be hidden until the group is allocated. The hidden allocation process will be performed using sequential, numbered, opaque and sealed envelopes. The outcome assessors, trialists (care provider and investigator) and participants will be blinded to the performed procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor

Model Details: Participants will be randomly allocated via an online generator (www.random.org) in one of three groups (1:1:1): anodal tDCS of M1 + PES; anodal tDCS of DLPFC + PES; Sham of M1 + PES.

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 3, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 3, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share