TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain

Chronic Pain Clinical Trial

— TDCS  

Official title:

Effects of Transcranial Stimulation by Direct Current Associated With Laterality Trainnning in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204627
• Other study ID #: 94350518.6.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo General Hospital
• Contact: Clarice Tanaka
• Phone: 551126616867
• Email: cltanaka[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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);

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain

Intervention

Device:
• TDCS
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) - Laterality
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.

Other:
• Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.
• Landscape recognition
Image recognition training that does not refer to right/left discrimination.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain symptoms	Change from Baseline in pain symptoms on the Visual Scale after treatment	up to 3 months
Secondary	Clinical Global Impression	Change from Baseline in pain severity on the Clinical Global Impression scale after treatment	up to 3 months