Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain
CompletedPhase 2, Phase 3NCT04077632
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effects of Transcranial Direct Current Stimulation on Heart Rate Variability in Chronic Low Back Pain Patients: a Randomized Controlled Trial
- Conditions
- Interventions
- Sponsor
- Universidade Federal do Piauí
- Start date
- 2019-10-01
- Primary completion
- 2021-06-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04077632