Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
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
Sites / Locations
- Department of Physical Therapy. Federal University of PiauiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS (anodal)
tDCS (sham)
Arm Description
Real transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
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).
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
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
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).
Full Information
NCT ID
NCT04077632
First Posted
August 28, 2019
Last Updated
April 29, 2021
Sponsor
Universidade Federal do Piauí
1. Study Identification
Unique Protocol Identification Number
NCT04077632
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Piauí
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS (anodal)
Arm Type
Experimental
Arm Description
Real transcranial direct current stimulation tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
Arm Title
tDCS (sham)
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
HRV frequency-domain measures
Description
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
Time Frame
After 13 minutes of tDCS
Title
HRV time-domain measures
Description
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).
Time Frame
After 13 minutes of tDCS
Secondary Outcome Measure Information:
Title
HRV frequency-domain measures
Description
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
Time Frame
After 20 minutes of tDCS
Title
HRV time-domain measures
Description
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).
Time Frame
After 20 minutes of tDCS
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Adverse effects will be evaluated using structured questionnaire
Time Frame
After 20 minutes of tDCS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid A Dias, PT
Phone
+5586999085800
Email
ingriddias@ufpi.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuad A Hazime, PhD
Organizational Affiliation
Physical Therapy Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy. Federal University of Piaui
City
Parnaíba
State/Province
Piauí
ZIP/Postal Code
64202020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid A Dias, PT
Phone
+55 86 3323-5209
Email
ingriddias@ufpi.edu.br
12. IPD Sharing Statement
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Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain
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