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The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:
Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture combined with corticosteroids group | Experimental | Participants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. |
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| Sham acupuncture combined with corticosteroids group | Sham Comparator | Participants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6) |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing improvement | Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing outcomes at multiple time points | Changes in PTA at weeks 1, 2, 4, 8, and 12 | week 1, 2, 4, 8, and 12 |
| Word Recognition Score (WRS) | Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiming Hao, MD, Doctor | Contact | 86-18017321721 | haoweiming1993@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT Hospital of Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture | Procedure | The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding. |
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| weeks 1, 2, 4, 8, and 12 |
| Sudden hearing loss recovery grade | Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria | weeks 1, 2, 4, 8, and 12 |
| TCM symptom score | Change from baseline to week 8 using the pattern-specific TCM symptom scale | week 8 |
| Sensory Organization Test | Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Insomnia Severity Index (ISI) | Changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Dizziness Handicap Inventory (DHI) | Changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Tinnitus Handicap Inventory (THI) | Changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Hospital Anxiety and Depression Scale (HADS) | Changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Quality of life (SF-36) | Changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Aural fullness scale (AFS) | Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12 | weeks 1, 2, 4, 8, and 12 |
| Salvage treatment rate | Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14 | day 14 |
| Safety outcome | Proportion of adverse events in both groups at week 8 | week 8 |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |