Clinical trial NCT04077632: Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain
Official title: Effects of Transcranial Direct Current Stimulation on Heart Rate Variability in Chronic Low Back Pain Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Low-back Pain
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HRV frequency-domain measures
timeFrame: After 13 minutes of tDCS
measure: HRV time-domain measures
timeFrame: After 13 minutes of tDCS
Secondary outcomes:
measure: HRV frequency-domain measures
timeFrame: After 20 minutes of tDCS
measure: HRV time-domain measures
timeFrame: After 20 minutes of tDCS
Other outcomes:
measure: Adverse effects
timeFrame: After 20 minutes of tDCS
Locations:
city: Parnaíba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: Piauí
Study officials:
affiliation: Physical Therapy Department
name: Fuad A Hazime, PhD
role: PRINCIPAL_INVESTIGATOR
References: