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Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial
Feng Xia1, Junliang Han, Xuedong Liu
1Department of Neurology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shaanxi, China.
Trials
|June 23, 2011
Summary
This study compares prednisolone and staging acupuncture for Bell's palsy recovery. It aims to find the most effective treatment combination for facial nerve recovery in patients.
Area of Science:
- Neurology
- Integrative Medicine
- Clinical Trials
Background:
- Bell's palsy presents various treatment options.
- Corticosteroids (prednisolone) are a proven therapy.
- Acupuncture is a common treatment in China, with staging showing promise.
Purpose of the Study:
- To compare prednisolone and staging acupuncture for facial nerve recovery in Bell's palsy.
- To determine if combining prednisolone with staging acupuncture is more effective than prednisolone alone.
Main Methods:
- A multi-center randomized controlled trial involving 1200 patients (18-75 years) within 72 hours of symptom onset.
- Six treatment groups: placebo prednisolone, prednisolone, placebo prednisolone + acute stage acupuncture, prednisolone + acute stage acupuncture, placebo prednisolone + resting stage acupuncture, prednisolone + resting stage acupuncture.
- Primary outcome: time to complete facial function recovery (Sunnybrook/House-Brackmann scales). Secondary outcomes: pain, synkinesis, spasms, contractures, and residual symptoms.
Main Results:
- Results are pending from this large-scale randomized controlled trial.
Conclusions:
- The trial will assess the efficacy of prednisolone and staging acupuncture for Bell's palsy.
- It aims to identify the optimal combination therapy for treating Bell's palsy.