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

Chronic Low-back Pain Clinical Trial

Official title:

Effects of Transcranial Direct Current Stimulation on Heart Rate Variability in Chronic Low Back Pain Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077632
• Other study ID #: tDCS and HRV
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2019
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 27, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy. Federal University of Piaui	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Adverse effects will be evaluated using structured questionnaire	After 20 minutes of tDCS
Primary	HRV frequency-domain measures	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	After 13 minutes of tDCS
Primary	HRV time-domain measures	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).	After 13 minutes of tDCS
Secondary	HRV frequency-domain measures	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	After 20 minutes of tDCS
Secondary	HRV time-domain measures	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).	After 20 minutes of tDCS