Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204627
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2020-08-27
Brief Title:
TDCS and Laterality Trainnning in Patients With Chronic Neck Pain
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effects of Transcranial Stimulation by Direct Current Associated With Laterality Trainnning in Patients With Chronic Neck Pain
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDCS
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None