Chronic Pain, Neck Pain
Conditions
Keywords
chronic pain, neck pain, functional laterality, transcranial direct current stimulation
Brief 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.
Interventions
DEVICETDCS
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.
DEVICERecognize (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.
OTHERSham TDCS
TDCS sham: The device remains inactive for 20 minutes.
OTHERLandscape recognition
Image recognition training that does not refer to right/left discrimination.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The study will be controlled, randomized and double-blind.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain symptoms | up to 3 months | Change from Baseline in pain symptoms on the Visual Scale after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression | up to 3 months | Change from Baseline in pain severity on the Clinical Global Impression scale after treatment |
Countries
Brazil
Contacts
Primary ContactClarice Tanaka
Outcome results
None listed