Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain

NCT ID: NCT04077632

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2023-11-27

Brief Summary

Chronic low back (CLBP) pain is an important public health and socioeconomic problem worldwide and, despite the volume of research in the area, it remains a difficult condition to treat. There are some evidences that altered heart rate variability (HRV) parameters are associated with different clinical disorders, such as chronic low back pain. For instances, diminished parasympathetic activity has been explored as a potential therapeutic target. Considering the dynamic interaction between brain and heart, neuromodulatory strategies targeting this relationship could exert a positive influence on cardiac autonomic system and pain modulation systems.

Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique that has been presenting recent advances in the treatment of chronic pain. However, tDCS application focusing on brain-heart interaction has not been extensively explored, especially on chronic pain conditions.

This study aims to investigate the effects of tDCS on HRV in chronic low back pain patients. Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) or tDCS (sham) in a single session protocol. The primary clinical outcome (HRV parameter) will be collected before, during and post-tDCS. The data will be collected by a blind examiner to the treatment allocation.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS (anodal)

Real transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).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.

tDCS (sham)

Sham transcranial direct current stimulation tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).

Group Type: SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).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.

Interventions

Transcranial direct current stimulation

tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 tDCS
• Disc herniation with nerve compression Neurological
• Psychiatric
• Rheumatologic diseases
• Impaired sensibility
• Use of pacemakers or other implanted devices
• Pregnancy
• Cardiovascular diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Piauí

OTHER

Sponsor Role: lead

Responsible Party

Fuad Ahmad Hazime

Clinical Professor - Physical Therapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuad A Hazime, PhD

Role: PRINCIPAL_INVESTIGATOR

Physical Therapy Department

Locations

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, Brazil

Countries

Brazil

Other Identifiers

tDCS and HRV

Identifier Type: -

Identifier Source: org_study_id