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

Phase 2

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT04077632
• Lead Sponsor: Universidade Federal do Piauí

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-04
• Study Start: 2019-10-01
• Primary Completion: 2021-06-30
• Status Verified: 2023-11
• Study Completion: 2023-11-27
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HRV frequency-domain measures	After 13 minutes of tDCS	Frequency domain analysis is conducted to evaluate two components: high frequency (HF) (0.14 and 0.40 Hz), related to the parasympathetic nervous system, and low frequency (LF) (0.004 and 0.15 Hz), related to the sympathetic and parasympathetic nervous system, with predominance of the sympathetic component
HRV time-domain measures	After 13 minutes of tDCS	Time domain analysis is related to global autonomic modulation and is conducted to evaluate differences between RR normal intervals (NN), defined as the temporal distance between consecutive "normal" beats (sinoatrial depolarizations) between the R peaks of the QRS complex, and their measurements including standard deviation of NN intervals (SDNN), standard deviation of mean RR intervals (SDANN), root mean square differences of successive RR intervals (RMSSD), and the percentage of normal RR intervals that differ by 50 ms (pNN50).

Secondary Outcome Measures

Name	Time	Method
HRV frequency-domain measures	After 20 minutes of tDCS	Frequency domain analysis is conducted to evaluate two components: high frequency (HF) (0.14 and 0.40 Hz), related to the parasympathetic nervous system, and low frequency (LF) (0.004 and 0.15 Hz), related to the sympathetic and parasympathetic nervous system, with predominance of the sympathetic component
HRV time-domain measures	After 20 minutes of tDCS	Time domain analysis is related to global autonomic modulation and is conducted to evaluate differences between RR normal intervals (NN), defined as the temporal distance between consecutive "normal" beats (sinoatrial depolarizations) between the R peaks of the QRS complex, and their measurements including standard deviation of NN intervals (SDNN), standard deviation of mean RR intervals (SDANN), root mean square differences of successive RR intervals (RMSSD), and the percentage of normal RR intervals that differ by 50 ms (pNN50).

Trial Locations

Locations (1)

Department of Physical Therapy. Federal University of Piaui; 🇧🇷 Parnaíba, Piauí, Brazil