Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2x2 Factorial Trial

What this Trial Is About

Researchers are evaluating the effects of intradermal acupuncture (IA) and a guided self-rehabilitation management program (GRMP), alone or combined, in patients with severe Bell's Palsy. The trial includes adults diagnosed with Bell's Palsy who have moderate to severe facial paralysis and have received steroid treatment early after symptom onset. The study is designed as a randomized, placebo-controlled, 2x2 factorial trial to compare these interventions and their impact on recovery. Participants are randomly assigned to one of four groups receiving either active or sham IA along with either the guided self-rehabilitation program or health education. Active IA involves inserting small needles at specific points retained for 72 hours with daily pressing exercises, while sham IA uses a non-penetrating device with similar procedures. The self-rehabilitation program includes twice-weekly outpatient sessions with therapists teaching facial exercises and managing symptoms, plus daily home exercises and diaries, lasting up to 24 weeks or until full recovery. Throughout the study, participants visit the clinic regularly every 4 weeks for assessments up to 24 weeks. Researchers will measure the proportion of patients who fully recover facial function by week 24 and other facial nerve function scales at multiple time points. Safety and symptom changes are monitored, including muscle activity and facial disability indexes. Participants also keep track of their exercises and receive ongoing support from therapists during the study period.

Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy