The Use of tDCS in the Orofacial Pain

Orofacial Pain Clinical Trial

Official title:

The Application of New Diagnostic (Thermovision) and Treatment (tDCS) Procedures in Patients With Drug-resistant Orofacial Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584384
• Other study ID #: 53/22 Grant AZV VES 2023VFN
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: Jitka Fricova, M.D., Ph.D.
• Phone: 0042022496 6370
• Email: jitka.fricova[@]vfn.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Orofacial Pain

Intervention

Device:
• Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulatory method utilizing weak electrical currents to elicit short and long-term central nervous system changes.
• Sham Transcranial Direct Current Stimulation
The sham was administered using the same tDCS devices as in the active group with a preprogrammed sham protocol of 20 minutes to be virtually indistinguishable from the active stimulation.

Locations

Country	Name	City	State
Czechia	Pain Management Centre, General University Hospital in Prague; Charles University in Prague	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The McGill Pain Questionnaire (short form).	The Short-form McGill Pain Questionnaire is a standardized questionnaire assessing pain's sensory and affective dimensions. The types of pain are scaled as to their intensity between 1-4 (a higher value denotes higher intensity), the overall intensity is scaled between 0-5 (a higher value denotes higher intensity), and VAS is used to visualize the notion of pain (evaluated on a scale of 0-10, a higher value denotes higher intensity).	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T2.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T3.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T3 (6 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T4.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T4 (10 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T5.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T5 (14 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T6.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T6 (18 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T7.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T7 (22 weeks since T1)
Primary	Changes in The McGill Pain Questionnaire (short form) at T8.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T8 (26 weeks since T1)
Primary	The numeric rating scale (NRS) as part of "pain diary"	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Primary	Changes in the numeric rating scale (NRS) every day of them follow-up period.	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.	Measured every day since T1 up until T8. (for 26 weeks in total)
Primary	The Margolis Pain Diagram	The Margolis pain diagram weights the extension and distribution of pain, expressed as the percentage of body surface in pain and its location. The tool consists of a dorsal and a ventral drawing of the body. The subjects are asked to shade areas in which they have experienced pain.	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Primary	Changes in the Margolis Pain Diagram at T2.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T3.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T3 (6 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T4.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T4 (10 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T5.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T5 (14 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T6.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T6 (18 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T7.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T7 (22 weeks since T1)
Primary	Changes in the Margolis Pain Diagram at T8.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T8 (26 weeks since T1)
Primary	The questionnaire of interference with daily activities	A standardized questionnaire to evaluate the interference of pain with daily activities. Minimum=0 points, maximum=5 points. A higher score generally means more severe interference.	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Primary	Changes in the questionnaire of interference with daily activities at T2.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T3.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T3 (6 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T4.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T4 (10 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T5.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T5 (14 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T6.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T6 (18 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T7.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T7 (22 weeks since T1)
Primary	Changes in the questionnaire of interference with daily activities at T8.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T8 (26 weeks since T1)
Secondary	Beck's Depression Inventory (BDI)	A standardized questionnaire to evaluate the symptoms of depression. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T2.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T3.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T3 (6 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T4.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T4 (10 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T5.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T5 (14 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T6.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T6 (18 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T7.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T7 (22 weeks since T1)
Secondary	Changes in Beck's Depression Inventory (BDI) at T8.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T8 (26 weeks since T1)
Secondary	Beck Anxiety Inventory (BAI)	A standardized questionnaire to evaluate the symptoms of anxiety. Minimum=0 points, maximum=63 points. A higher score generally means more severe anxiety	The measurement will be established as a baseline prior to the stimulation series. (at T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T2.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T2 (after the 6th stimulation, 2 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T3.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T3 (6 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T4.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T4 (10 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T5.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T5 (14 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T6.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T6 (18 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T7.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T7 (22 weeks since T1)
Secondary	Changes in Beck Anxiety Inventory (BAI) at T8.	Changes compared to the baseline (T1) will be calculated and further statistically compared between the groups. A negative difference to the baseline means an improvement	Measured at T8 (26 weeks since T1)