Electroacupuncture for trigeminal neuralgia with anxiety disorders: study protocol for a randomized controlled trial
Rongrong Li1,2, Yaxuan Xu1,2, Lingyu Zhang1,2
1Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Introduction:
Trigeminal neuralgia (TN) is extremely vulnerable to inducing anxiety disorders in TN patients owing to the severe intensity of pain and recurrent episodes. The efficacy of the routine management of TN with anxiety disorders is still unsatisfactory. Acupuncture has been widely utilized in the treatment of TN for many years; however, the effectiveness of Electroacupuncture (EA) for TN with anxiety disorders remains uncertain. Therefore, this randomized, controlled, single-blinded trial was designed to investigate the efficacy and safety of EA for TN with anxiety disorders.
Methods:
This single-center, prospective, randomized controlled trial will recruit 60 TN patients with anxiety. All patients will be randomly assigned to the EA or sham EA group in a 1:1 ratio via a computerized central randomization system. The total trial duration is 18 weeks, including a 2-week baseline phase, a 4-week treatment phase, and a 12-week follow-up phase. Participants who meet the inclusion criteria will receive active EA or sham EA treatment for 60 min, three times a week, for 4 weeks.
Planned Outcomes:
The primary outcome is the change of Beck Anxiety Inventory score and Visual Analog Scale score from baseline, while the BPI-Facial scores will be regarded as the secondary outcomes. All adverse effects will also be assessed during the study period. Outcome measures will be assessed at pre-intervention, post-intervention (week 4), and at the end of follow-up (week 16).
Trial Registration:
Chinese Clinical Trial Registry: ChiCTR2300079048. This study was registered on December 25, 2023.