Intradermal acupuncture and self-rehabilitation for severe Bell's Palsy

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

This study is testing if a combination of acupuncture and a self-rehabilitation program can help people with severe Bell's Palsy recover better than other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 552 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhangjiagang First People's Hospital (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06778473 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of intradermal acupuncture (IA) and a guided self-rehabilitation management program (GRMP) on patients with severe Bell's Palsy. Participants will be randomly assigned to one of four groups: active IA combined with GRMP, active IA with health education, sham IA with GRMP, or sham IA with health education. The interventions will continue until participants achieve complete recovery or complete the 24-week follow-up period, with assessments at regular intervals. The goal is to determine the efficacy of these treatments in improving recovery outcomes for Bell's Palsy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a first onset of Bell's Palsy affecting one side of the face and a moderate to severe HBGS score within 10 days of onset.

Not a fit: Patients with facial paralysis due to other medical conditions or those with severe allergies or skin issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery rates and quality of life for patients suffering from severe Bell's Palsy.

How similar studies have performed: While the specific combination of intradermal acupuncture and self-rehabilitation is novel, similar studies have shown positive outcomes with acupuncture in treating Bell's Palsy.

Eligibility criteria

Inclusion Criteria:

* Patients diagnosed with Bell's palsy according to "Clinical Practice Guideline: Bell's Palsy" published by AAO-HNS in 2013;
* First onset of Bell's palsy with only one side affected;
* On the 10th day after the onset of palsy, HBGS score ranging from grade IV to VI;
* According to the latest Chinese Guidelines for Bell's Palsy, within 72 hours of symptom onset for Bell's Palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day;
* Adults aged 18 years of age or older (no limitation on gender).

Exclusion Criteria:

* Facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, Hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis;
* Fear of intradermal acupuncture;
* allergy to adhesive tape;
* Severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system;
* Cognitive impairment, mental illness, contagious disease, pregnant and lactating;
* Previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.

Where this trial is running

Suzhou, Jiangsu

• Zhangjiagang First People's Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: yang Jiang, master — Zhangjiagang First People's Hospital
• Study coordinator: yang Jiang, master

Conditions Bell Palsy; Intradermal acupuncture; Self-rehabilitation