Chronic PainNCT04496661
Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain
A study testing Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation and Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation in people with Chronic Pain and Low Back Pain, run by Federal University of Paraíba.
Trial summary
Low back pain (LBP) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. A multimodal approach to pain management, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES), may improve outcomes in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Low Back Pain
- What is being tested?
- Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation and Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years;
- Diagnosis of chronic low back pain, lasting more than 6 months (The diagnosis of chronic lumbar pain will be based on clinical and neurophysiological criteria, according to the European Guidelines on Low Back Pain);
- Pain intensity of at least 4 in 10 in Visual Analogue Scale (VAS);
- Stable pharmacological treatment for at least one month before the study and throughout the study;
Who cannot join
- Intense pain from another origin, such as neuropathic pain;
- Alcohol or substance abuse;
- Associated diseases of the peripheral or central nervous system;
- Contraindications for non-invasive brain stimulation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain: a Protocol for a Pilot Randomized Controlled Trial
Low back pain (LBP) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. A multimodal approach to pain management, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES), may improve outcomes in chronic LBP. However, the optimal cerebral target for stimulation still remains controversial. This pilot trial aims to investigate whether active stimulation could promote additional gains to the PES results in LBP participants. The secondary objective is to investigate whether the stimulation of primary motor cortex and dorsolateral prefrontal cortex results in distinct clinical effects for the participants involved.
Read the detailed description
For this, a pilot, sham-controlled, double-blind, randomized clinical trial in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Sixty participants with chronic low back pain will be randomized into one of three tDCS groups associated with PES: motor primary cortex, dorsolateral prefrontal cortex and sham stimulation. Each group will receive transcranial direct current stimulation at an intensity of 2 mA for 30 minutes daily for 10 consecutive days. Participants will be assessed with a Brief Pain Inventory (BPI), Roland Morris Disability Questionnaire (RMDQ), Medical Outcomes Study 36-item Short - Form Health Survey (SF-36) and electromyography at baseline, endpoint (after 10 sessions) and 1-month follow up. This study will help to clarify the additive effects of tDCS combined with peripheral electrical stimulation on pain relief, muscle function and improvement in quality of life. Additionally, the investigators will provide data to identify optimal targets for management of chronic low back pain.
- Conditions
- Chronic Pain, Low Back Pain
- Being tested
- Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation, Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation, Sham tDCS and PES
- Keywords
- PES, tDCS
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation on M1 and Peripheral Electrical StimulationDevice
Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The participants will be positioned in ventral decubitus position. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on C3 to stimulate the left primary motor cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).
Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical StimulationDevice
Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on F3 to stimulate the left dorsolateral cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).
Sham tDCS and PESDevice
For sham tDCS and PES stimulation, patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes. The anodic electrode will be positioned on the left primary motor cortex, but the current will be turned off automatically after 30 seconds. The reference electrode will be positioned in the supra orbital contralateral region. For sham PES stimulations, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed), but the current will be turned off automatically after 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| tDCS over M1 and PES | Experimental | Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes. Receives: Device: Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation |
| tDCS over DLPFC and PES | Experimental | Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes. Receives: Device: Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation |
| Sham tDCS and PES | Sham comparator | Sham tDCS and PES stimulation. Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. The currents will be turned off automatically after 30 seconds. Duration: 30 minutes. Receives: Device: Sham tDCS and PES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity
Pain severity will be assessed with Numerical Rating Scales (NRS), which refers to a subjective measure in which individuals classify their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Changes in pain interference in activities of daily living
The Brief Pain Inventory (BPI) assesses multidimensional aspects of pain. It includes 15 items that evaluate the existence, severity, location, functional interference, applied therapeutic strategies and effectiveness of pain treatment. It is an instrument with adequate validity and reproducibility, commonly used in the evaluation of patients with chronic pain.
Measured: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Secondary outcomes (3)
Functional disability associated with chronic low back pain measured by Roland Morris Disability Questionnaire (RMDQ)
The Roland Morris Disability Questionnaire (RMDQ) functional disability associated with chronic low back pain. Composed of 24 questions, with a variation of scores between 0 and 24 points: Zero point corresponds to a person without complaints and the maximum value (24 points) to a patient with very severe limitations.
Measured: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Quality of life (SF-36)
The Medical Outcomes Short-Form Health Survey (SF-36) - a general health assessment instrument, originally created in English, which is easy to administer and understand. It consists of 36 questions, covering eight components, functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health assessed by 35 questions and one more comparative question between current and health one year ago.
Measured: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Electrical activity of lumbar/multifidus (ML) and transverse abdominal (TrA)
Surface Electromyography (EMGs) of the lumbar/multifidus (ML) and transverse abdominal (TrA) will be recorded using an 8-channel data acquisition system (model W4X8, Biometrics Ltd. , UK), bluetooth, with the following technical characteristics: hardware with 12-bit analog-to-digital (A/D) conversion board, 1000-fold gain amplifier, 20 to 500 Hz bandpass filter (2nd order Butterworth), common mode rejection ratio (RRMC) >100 dB, signal noise rate <3 mV RMS, 109 Ohms impedance, surface, bipolar, active, simple differential electrodes, 20-fold pre-amplification, reference electrode and DataLOG software for signal collection and analysis with 1000 Hz sampling frequency.
Measured: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study startNov 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated via an online generator (www.random.org) in one of three groups (1:1:1): anodal tDCS of M1 + PES; anodal tDCS of DLPFC + PES; Sham of M1 + PES.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496661
- Sponsor's protocol ID
- Painmodulation
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diniz LSM, Mousinho RRS, Cavalcante LL, Andrade SMMDS, Santos HHD, Andrade PR. Effects of TDCS and TENS on chronic low back pain: A randomized controlled clinical trial. J Bodyw Mov Ther. 2026 Jun;46:267-273. doi: 10.1016/j.jbmt.2025.10.044. Epub 2025 Oct 30.
PubMed 41927183
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for the Optimal tDCS Target Combined With Peripheral Electrical Stimulation in Chronic Low Back Pain: a Protocol for a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04496661
- Acronym / sponsor ID
- Painmodulation
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- PES, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain (LBP) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. A multimodal approach to pain management, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES), may improve outcomes in chronic LBP. However, the optimal cerebral target for stimulation still remains controversial. This pilot trial aims to investigate whether active stimulation could promote additional gains to the PES results in LBP participants. The secondary objective is to investigate whether the stimulation of primary motor cortex and dorsolateral prefrontal cortex results in distinct clinical effects for the participants involved.
Detailed description
For this, a pilot, sham-controlled, double-blind, randomized clinical trial in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Sixty participants with chronic low back pain will be randomized into one of three tDCS groups associated with PES: motor primary cortex, dorsolateral prefrontal cortex and sham stimulation. Each group will receive transcranial direct current stimulation at an intensity of 2 mA for 30 minutes daily for 10 consecutive days. Participants will be assessed with a Brief Pain Inventory (BPI), Roland Morris Disability Questionnaire (RMDQ), Medical Outcomes Study 36-item Short - Form Health Survey (SF-36) and electromyography at baseline, endpoint (after 10 sessions) and 1-month follow up. This study will help to clarify the additive effects of tDCS combined with peripheral electrical stimulation on pain relief, muscle function and improvement in quality of life. Additionally, the investigators will provide data to identify optimal targets for management of chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated via an online generator (www.random.org) in one of three groups (1:1:1): anodal tDCS of M1 + PES; anodal tDCS of DLPFC + PES; Sham of M1 + PES.
| Arm | Type | Receives |
|---|---|---|
| tDCS over M1 and PES | Experimental | Device: Transcranial Direct Current Stimulation on M1 and Peripheral Electrical StimulationAnodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes. |
| tDCS over DLPFC and PES | Experimental | Device: Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical StimulationAnodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area . Duration: 30 minutes. |
| Sham tDCS and PES | Sham comparator | Device: Sham tDCS and PESSham tDCS and PES stimulation. Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and PES (20Hz and 330ms) placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. The currents will be turned off automatically after 30 seconds. Duration: 30 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years;
- Diagnosis of chronic low back pain, lasting more than 6 months (The diagnosis of chronic lumbar pain will be based on clinical and neurophysiological criteria, according to the European Guidelines on Low Back Pain);
- Pain intensity of at least 4 in 10 in Visual Analogue Scale (VAS);
- Stable pharmacological treatment for at least one month before the study and throughout the study;
Key exclusion criteria (4 listed)
- Intense pain from another origin, such as neuropathic pain;
- Alcohol or substance abuse;
- Associated diseases of the peripheral or central nervous system;
- Contraindications for non-invasive brain stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation on M1 and Peripheral Electrical StimulationPatients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The participants will be positioned in ventral decubitus position. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on C3 to stimulate the left primary motor cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed). | Device | tDCS over M1 and PES |
| Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical StimulationPatients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on F3 to stimulate the left dorsolateral cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed). | Device | tDCS over DLPFC and PES |
| Sham tDCS and PESFor sham tDCS and PES stimulation, patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes. The anodic electrode will be positioned on the left primary motor cortex, but the current will be turned off automatically after 30 seconds. The reference electrode will be positioned in the supra orbital contralateral region. For sham PES stimulations, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed), but the current will be turned off automatically after 30 seconds. | Device | Sham tDCS and PES |
Primary outcome
Change in pain severity
Time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Pain severity will be assessed with Numerical Rating Scales (NRS), which refers to a subjective measure in which individuals classify their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable).
Changes in pain interference in activities of daily living
Time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
The Brief Pain Inventory (BPI) assesses multidimensional aspects of pain. It includes 15 items that evaluate the existence, severity, location, functional interference, applied therapeutic strategies and effectiveness of pain treatment. It is an instrument with adequate validity and reproducibility, commonly used in the evaluation of patients with chronic pain.
3 secondary outcomes
Functional disability associated with chronic low back pain measured by Roland Morris Disability Questionnaire (RMDQ)
Time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Quality of life (SF-36)
Time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Electrical activity of lumbar/multifidus (ML) and transverse abdominal (TrA)
Time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Derived from this study: PubMed 41927183Diniz LSM, Mousinho RRS, Cavalcante LL, Andrade SMMDS, Santos HHD, Andrade PR. Effects of TDCS and TENS on chronic low back pain: A randomized controlled clinical trial. J Bodyw Mov Ther. 2026 Jun;46:267-273. doi: 10.1016/j.jbmt.2025.10.044. Epub 2025 Oct 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen Andrade principal investigator
Federal University of Paraiba
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation and Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation in people with Chronic Pain and Low Back Pain, run by Federal University of Paraíba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade (+55 83 987772488, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (time frame: Baseline, endpoint (after 2 weeks) and the follow-up (after 1 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.