Clinical trial NCT05584384: The Use of tDCS in the Orofacial Pain
Official title: The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orofacial Pain
Keywords: Orofacial Pain
tDCS
trancranial DIrect Current Stimulation
NIBS
non-invasive brain stimulation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blinded, placebo-controlled, two-arm trial.
Primary purpose: TREATMENT

Brief summary: The trial´s main goal is to explore the use of transcranial direct current stimulation (tDCS) as a treatment option for persons suffering from orofacial pain. The aim of the trial is to further investigate the efficacy and longevity of tDCS in treating chronic pharmacoresistant orofacial pain.

A prospective, randomized, double-blinded, two-arm, sham-controlled design will be utilized. Primarily, the analgesic effect's intensity and duration will be assessed. Secondarily, the associated reduction of symptoms of anxiety and depression will be investigated, as well as the impact on the general quality of life. Anodal stimulation (6 sessions in 2 weeks, 2mA, 20 min, cathode over the opposite Fp area) of M1 contralateral to the pain location will be employed. Washout periods of 48-72 hours will be kept between applications to improve neuroplasticity changes' induction, which is estimated to reflect in the effect retention. Eight major evaluation points will be employed in 26 weeks, and a daily numeric rating scale (NRS) self-assessment.

The trial will potentially improve the quality of life, reduce the health burden caused by chronic orofacial pain, and provide further data on the use of tDCS in this setting, thus, enabling an additional route to manage the symptoms of pain in the future.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Orofacial Pain by a pain medicine specialist according to ICOP (International classification of orofacial pain) and ICHD3 (International classification of headache disorder)
* Stable analgesic therapy one month before the stimulation series

Exclusion Criteria:

* Changes to the analgesic therapy in 6 months following the stimulation series
* Non-compliance with the follow-ups
* General contraindications to tDCS - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses

Primary outcomes:
measure: The McGill Pain Questionnaire (short form).
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T2.
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T3.
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T4.
timeFrame: Measured at T4 (10 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T5.
timeFrame: Measured at T5 (14 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T6.
timeFrame: Measured at T6 (18 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T7.
timeFrame: Measured at T7 (22 weeks since T1)
measure: Changes in The McGill Pain Questionnaire (short form) at T8.
timeFrame: Measured at T8 (26 weeks since T1)
measure: The numeric rating scale (NRS) as part of "pain diary"
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in the numeric rating scale (NRS) every day of them follow-up period.
timeFrame: Measured every day since T1 up until T8. (for 26 weeks in total)
measure: The Margolis Pain Diagram
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in the Margolis Pain Diagram at T2.
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T3.
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T4.
timeFrame: Measured at T4 (10 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T5.
timeFrame: Measured at T5 (14 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T6.
timeFrame: Measured at T6 (18 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T7.
timeFrame: Measured at T7 (22 weeks since T1)
measure: Changes in the Margolis Pain Diagram at T8.
timeFrame: Measured at T8 (26 weeks since T1)
measure: The questionnaire of interference with daily activities
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in the questionnaire of interference with daily activities at T2.
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T3.
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T4.
timeFrame: Measured at T4 (10 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T5.
timeFrame: Measured at T5 (14 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T6.
timeFrame: Measured at T6 (18 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T7.
timeFrame: Measured at T7 (22 weeks since T1)
measure: Changes in the questionnaire of interference with daily activities at T8.
timeFrame: Measured at T8 (26 weeks since T1)
Secondary outcomes:
measure: Beck's Depression Inventory (BDI)
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Beck's Depression Inventory (BDI) at T2.
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T3.
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T4.
timeFrame: Measured at T4 (10 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T5.
timeFrame: Measured at T5 (14 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T6.
timeFrame: Measured at T6 (18 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T7.
timeFrame: Measured at T7 (22 weeks since T1)
measure: Changes in Beck's Depression Inventory (BDI) at T8.
timeFrame: Measured at T8 (26 weeks since T1)
measure: Beck Anxiety Inventory (BAI)
timeFrame: The measurement will be established as a baseline prior to the stimulation series. (at T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T2.
timeFrame: Measured at T2 (after the 6th stimulation, 2 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T3.
timeFrame: Measured at T3 (6 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T4.
timeFrame: Measured at T4 (10 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T5.
timeFrame: Measured at T5 (14 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T6.
timeFrame: Measured at T6 (18 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T7.
timeFrame: Measured at T7 (22 weeks since T1)
measure: Changes in Beck Anxiety Inventory (BAI) at T8.
timeFrame: Measured at T8 (26 weeks since T1)
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Pain Management Centre, General University Hospital in Prague; Charles University in Prague
Study officials:
affiliation: General University Hospital in Prague; Charles University in Prague
name: Jitka Fricova, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: General University Hospital in Prague; Charles University in Prague
name: Tadeas Mares, M.D.
role: STUDY_CHAIR
affiliation: General University Hospital in Prague; Charles University in Prague
name: Martin Anders, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: General University Hospital in Prague; Charles University in Prague
name: Jozef Buday, M.D., Ph.D.
role: STUDY_CHAIR
References: