Neck PainTDCSNCT06204627
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
A study testing TDCS, Recognize (hand) - Laterality and Landscape recognition in people with Neck Pain and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Chronic neck pain leads to decreased quality of life and absenteeism at work, generating great personal and socio-economic impact. It has been shown that patients with chronic pain have late recognition of the laterality of the hand, which is related to the duration of symptoms and pain evoked by the execution of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- TDCS, Recognize (hand) - Laterality and Landscape recognition
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Sep 2023to 1 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants over 18 years old;
- pain in the cervical region, lasting more than three months and with intensity greater than 40/100 on the visual analog scale
Who cannot join
- history of seizures or epilepsy,
- history of head trauma,
- intracranial hypertension,
- intracranial metal clip,
- pregnant or breastfeeding women,
- skin lesions at the current application site;
Show all 13Show fewer
- changes in sensitivity and allergy in the electrode positioning region.
- intermittent pain;
- Cancer;
- cardiac pacemaker;
- severe spinal diseases, such as recent fractures or ankylosing spondylitis;
- serious cardiorespiratory diseases;
- participants who refuse to sign the Free and Informed Consent Form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade de São Paulo
São Paulo, 05403-000
Clarice Tanaka, PhD
About this study
Official title: Effects of Transcranial Stimulation by Direct Current Associated With Laterality Trainnning in Patients With Chronic Neck Pain
Chronic neck pain leads to decreased quality of life and absenteeism at work, generating great personal and socio-economic impact. It has been shown that patients with chronic pain have late recognition of the laterality of the hand, which is related to the duration of symptoms and pain evoked by the execution of the movement. These findings suggest that chronic pain and the consequent disuse of certain motor functions may involve a reorganization of the cortical representation of the body scheme or motor planning.
Non-invasive neuromodulation, such as transcranial direct current stimulation (TDCS), allows modulating cortical excitability and promoting pain relief.
This study intends to verify the effects of the association of noninvasive brain stimulation with TDCS with an intervention with visual and motor stimuli related to laterality in patients with neck pain.
Read the detailed description
The study will be controlled, randomized, double-blind and will include patients with chronic neck pain, divided into four groups:
- active TDCS associated with laterality recognition stimuli (n = 25);
- active TDCS associated with landscape recognition stimuli (n = 25);
- TDCS sham associated with laterality recognition stimuli (n = 25);
- TDCS sham associated with landscape recognition stimuli (n = 25);
Eight induction sessions will be held twice a week for four weeks. Patients who present a positive response in the first reassessment (responders) will remain in the study follow-up and will undergo a weekly maintenance session, for four weeks, and two more biweekly sessions.
The following instruments will be used for evaluation: motor safety thresholds through a MagVenture pulse generator with a flat surface coil, figure 8; OPAL, device with sensors; Recognize™ application; Visual Analog Scale (VAS); Brief Pain Inventory (BDI); Clinical Global Impression - ICG (patient and evaluated version); Pain McGill Standard Questionnaire - Short Format; Hospital Anxiety and Depression Scale (HAD); 36-item summary health survey from the Medical Outcomes Study (SF-36); Mini best test; neurodynamic tests (upper limb tension tests); and quantitative sensory tests. In addition to the pre- and post-intervention assessments, there will be post-treatment follow-up performed three, six and 12 months after randomization by telephone or e-mail. It is expected that the combined application of tDCS with stimuli related to laterality will have positive effects in patients with neck pain, impacting on variables such as pain, functional movements and quality of life of these patients.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- TDCS, Recognize (hand) - Laterality, Sham TDCS, Landscape recognition
- Keywords
- chronic pain, neck pain, functional laterality, transcranial direct current stimulation
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCSDevice
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Recognize (hand) - LateralityDevice
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Sham TDCSOther
TDCS sham: The device remains inactive for 20 minutes.
Landscape recognitionOther
Image recognition training that does not refer to right/left discrimination.
| Study group | Role | What they receive |
|---|---|---|
| Active bipolar TDCS associated with laterality recognition stimuli | Active comparator | Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes. Meanwhile, they will use the Regognise hand application to discriminate right/left side of hand images. Receives: Device: TDCS; Device: Recognize (hand) - Laterality |
| Active bipolar TDCS associated with landscape recognition stimuli | Active comparator | Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes.
At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality. Receives: Device: TDCS; Other: Landscape recognition |
| Sham TDCS associated with laterality recognition stimuli | Active comparator | Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. Meanwhile, they will use the Regognise hand app to discriminate right/left hand images. Receives: Device: Recognize (hand) - Laterality; Other: Sham TDCS |
| Sham TDCS associated with landscape recognition stimuli | Placebo comparator | Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality. Receives: Other: Sham TDCS; Other: Landscape recognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain symptoms
Change from Baseline in pain symptoms on the Visual Scale after treatment
Measured: up to 3 months
Secondary outcomes (1)
Clinical Global Impression
Change from Baseline in pain severity on the Clinical Global Impression scale after treatment
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start30 Sep 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- The study will be controlled, randomized, double-blind and will include patients with chronic neck pain, divided into four groups: 1. active TDCS associated with laterality recognition stimuli (n = 25); 2. active TDCS associated with landscape recognition stimuli (n = 25); 3. TDCS sham associated with laterality recognition stimuli (n = 25); 4. TDCS sham associated with landscape recognition stimuli (n = 25).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clarice Tanaka, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204627
- Sponsor's protocol ID
- 94350518.6.0000.0068
- Acronym
- TDCS
- Status last verified
- May 2024
- First submitted
- 27 Aug 2020
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Stimulation by Direct Current Associated With Laterality Trainnning in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06204627
- Acronym / sponsor ID
- TDCS / 94350518.6.0000.0068
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- chronic pain, neck pain, functional laterality, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
Chronic neck pain leads to decreased quality of life and absenteeism at work, generating great personal and socio-economic impact. It has been shown that patients with chronic pain have late recognition of the laterality of the hand, which is related to the duration of symptoms and pain evoked by the execution of the movement. These findings suggest that chronic pain and the consequent disuse of certain motor functions may involve a reorganization of the cortical representation of the body scheme or motor planning.
Non-invasive neuromodulation, such as transcranial direct current stimulation (TDCS), allows modulating cortical excitability and promoting pain relief.
This study intends to verify the effects of the association of noninvasive brain stimulation with TDCS with an intervention with visual and motor stimuli related to laterality in patients with neck pain.
Detailed description
The study will be controlled, randomized, double-blind and will include patients with chronic neck pain, divided into four groups:
- active TDCS associated with laterality recognition stimuli (n = 25);
- active TDCS associated with landscape recognition stimuli (n = 25);
- TDCS sham associated with laterality recognition stimuli (n = 25);
- TDCS sham associated with landscape recognition stimuli (n = 25);
Eight induction sessions will be held twice a week for four weeks. Patients who present a positive response in the first reassessment (responders) will remain in the study follow-up and will undergo a weekly maintenance session, for four weeks, and two more biweekly sessions.
The following instruments will be used for evaluation: motor safety thresholds through a MagVenture pulse generator with a flat surface coil, figure 8; OPAL, device with sensors; Recognize™ application; Visual Analog Scale (VAS); Brief Pain Inventory (BDI); Clinical Global Impression - ICG (patient and evaluated version); Pain McGill Standard Questionnaire - Short Format; Hospital Anxiety and Depression Scale (HAD); 36-item summary health survey from the Medical Outcomes Study (SF-36); Mini best test; neurodynamic tests (upper limb tension tests); and quantitative sensory tests. In addition to the pre- and post-intervention assessments, there will be post-treatment follow-up performed three, six and 12 months after randomization by telephone or e-mail. It is expected that the combined application of tDCS with stimuli related to laterality will have positive effects in patients with neck pain, impacting on variables such as pain, functional movements and quality of life of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study will be controlled, randomized, double-blind and will include patients with chronic neck pain, divided into four groups: 1. active TDCS associated with laterality recognition stimuli (n = 25); 2. active TDCS associated with landscape recognition stimuli (n = 25); 3. TDCS sham associated with laterality recognition stimuli (n = 25); 4. TDCS sham associated with landscape recognition stimuli (n = 25).
| Arm | Type | Receives |
|---|---|---|
| Active bipolar TDCS associated with laterality recognition stimuli | Active comparator | Device: TDCS, Device: Recognize (hand) - LateralityParticipants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes. Meanwhile, they will use the Regognise hand application to discriminate right/left side of hand images. |
| Active bipolar TDCS associated with landscape recognition stimuli | Active comparator | Device: TDCS, Other: Landscape recognitionParticipants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes. At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality. |
| Sham TDCS associated with laterality recognition stimuli | Active comparator | Device: Recognize (hand) - Laterality, Other: Sham TDCSParticipants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. Meanwhile, they will use the Regognise hand app to discriminate right/left hand images. |
| Sham TDCS associated with landscape recognition stimuli | Placebo comparator | Other: Sham TDCS, Other: Landscape recognitionParticipants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- participants over 18 years old;
- pain in the cervical region, lasting more than three months and with intensity greater than 40/100 on the visual analog scale
Key exclusion criteria (13 listed)
- history of seizures or epilepsy,
- history of head trauma,
- intracranial hypertension,
- intracranial metal clip,
- pregnant or breastfeeding women,
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 |
|---|---|---|
| TDCSTechnique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief. | Device | Active bipolar TDCS associated with landscape recognition stimuli, Active bipolar TDCS associated with laterality recognition stimuli |
| Recognize (hand) - LateralityThis technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain. | Device | Active bipolar TDCS associated with laterality recognition stimuli, Sham TDCS associated with laterality recognition stimuli |
| Sham TDCSTDCS sham: The device remains inactive for 20 minutes. | Other | Sham TDCS associated with landscape recognition stimuli, Sham TDCS associated with laterality recognition stimuli |
| Landscape recognitionImage recognition training that does not refer to right/left discrimination. | Other | Active bipolar TDCS associated with landscape recognition stimuli, Sham TDCS associated with landscape recognition stimuli |
Primary outcome
Pain symptoms
Time frame: up to 3 months
Change from Baseline in pain symptoms on the Visual Scale after treatment
1 secondary outcome
Clinical Global Impression
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TDCS, Recognize (hand) - Laterality and Landscape recognition in people with Neck Pain and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 13 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Clarice Tanaka (551126616867, cltanaka@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain symptoms (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.