NCT06204627

TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neck Pain
• Chronic Pain

Interventions

Type	Name	Description
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.
DEVICE	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.
OTHER	Landscape recognition	Image recognition training that does not refer to right/left discrimination.

Timeline

• Start date: 2023-09-30
• Primary completion: 2024-08-30
• Completion: 2024-12-01
• First posted: 2024-01-12
• Last updated: 2024-05-16

Locations

1 site across 1 country: Brazil