Evaluating the best timing for acupuncture treatment in facial paralysis

Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial

This study is testing the best timing for acupuncture treatment to help people with Bell's palsy recover from facial paralysis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06393231 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the optimal timing for acupuncture and moxibustion therapy in patients with peripheral facial paralysis, specifically Bell's palsy. A total of 120 patients will be randomly assigned to either an observation group or a control group, both receiving acupuncture combined with infrared treatment. The primary outcome will be measured using the Sunnybrook score at six months post-onset, with secondary measures including various scales assessing facial function and psychological well-being. The goal is to determine the best time to conclude acupuncture treatment to minimize complications and enhance recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have been diagnosed with peripheral facial paralysis within the last 7 days.

Not a fit: Patients with recurrent facial nerve palsy or those with other complicating health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery outcomes and reduced complications for patients with peripheral facial paralysis.

How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach to timing in facial paralysis treatment is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients aged 18-75 years.
2. Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
3. All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
4. Those who voluntarily sign the Research Informed Consent Form

Exclusion Criteria:

1. Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
2. Pregnant or nursing patients.
3. Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
4. Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation

Where this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Bingguo Xu

Conditions: Peripheral Facial Paralysis, peripheral facial paralysis, acupuncture, sequelae