Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Improvement rate of the CSIT score at 4 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture based on the "Form-Qi-Spirit" theory works to treat post-traumatic olfactory dysfunction in adults. It will also learn about the safety of this acupuncture treatment.
The main questions it aims to answer are:
Is the efficacy of 4-week acupuncture treatment superior to 4-week steroid treatment for post-traumatic olfactory dysfunction?
What medical problems or side effects do participants have when receiving acupuncture?
Researchers will compare real acupuncture plus a placebo (a look-alike pill with no active drug) to sham acupuncture (non-penetrating placebo needles) plus low-dose oral steroids (prednisone) - to see if the real acupuncture strategy works better than the steroid strategy for post-traumatic olfactory dysfunction.
Participants will:
Receive real acupuncture + placebo pills, OR sham acupuncture + low-dose prednisone, for 4 weeks
Undergo acupuncture/sham sessions 3 times per week (12 sessions in total)
Take the assigned pills daily (with tapering doses over 4 weeks)
Visit the clinic for smell tests, psychological assessments, and safety checks at baseline, at 4 weeks (end of treatment), and at 12 weeks (8 weeks after treatment ends)
Let me know if you need a more detailed version or any adjustments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with post-traumatic olfactory dysfunction who meet the diagnostic criteria;
- •Aged 18-60 years;
- •Subjects who have given informed consent and voluntarily participate and sign the informed consent form;
- •Have not received acupuncture treatment, olfactory disorder-related medications (such as intranasal corticosteroids or oral drugs), or olfactory training within the past 1 month;
- •Are in a stable post-traumatic condition without severe complications, and are able to cooperate with diagnosis, treatment, and evaluation.
排除标准
- •Patients with a clear history of viral infection or exposure to irritant substances prior to the onset of olfactory dysfunction;
- •History of nasopharyngeal tumor, or presence of active nasal diseases (sinusitis, nasal polyposis, atrophic rhinitis, allergy), as well as severe nasal obstruction caused by nasal stenosis or deformity;
- •History of chemotherapy or treatment with estrogen inhibitors (aromatase inhibitors), or prior use of medications known to be harmful to olfactory function before the onset of olfactory dysfunction;
- •Patients with cognitive impairment and neurodegenerative diseases (Alzheimer's disease and Parkinson's disease), or severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, olfactory hallucinations);
- •Current use of medications that may affect olfaction (e.g., antidepressants and antihistamines);
- •Allergy to prednisone;
- •Pregnant or lactating women.
研究组 & 干预措施
Treatment arm
The treatment group includes two interventions: acupuncture and a steroid placebo (prednisone placebo).
Acupoint selection: Fengchi (GB20, bilateral, quick needling), Jingbailao (bilateral, quick needling), Dazhuipang (bilateral, quick needling); Shenting (DU24), Baihui (DU20), Yingxiang penetrating Bitong (bilateral), Quanliao penetrating Bitong (bilateral), Hegu (LI4, bilateral), Wailaogong (bilateral), Zusanli (ST36, bilateral), Taichong (LR3, bilateral).
Procedure: First, the patient sits upright. Quick needling (without retaining needles) is performed at Fengchi, Jingbailao, and Dazhuipang. Then, the patient assumes a supine position. Needles are inserted Shenting, Baihui, etc.while deep needling is performed at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes.
Course: 3×/week for 4 weeks (12 sessions). Oral prednisone placebo at same dose/duration as control group.
干预措施: Acupuncture (Other)
control arm
Medication: Oral prednisone given as a short-term course (4 weeks). Dosage and tapering schedule: Week 1: 30 mg/d; Week 2: 15 mg/d; Week 3: 10 mg/d; Week 4: 5 mg/d, then discontinued after 4 weeks.
Sham acupuncture: Park sham acupuncture device (placebo needle) is used. The acupoint selection and operation sites are the same as those in the treatment group. After routine disinfection, the needle holder is applied to the acupoint, and the needle is inserted into the holder without penetrating the skin, and retained for 20 minutes. The treatment course is the same as the treatment group (3 times per week for 4 weeks).
干预措施: Corticosteroid therapy (Drug)
control arm
Medication: Oral prednisone given as a short-term course (4 weeks). Dosage and tapering schedule: Week 1: 30 mg/d; Week 2: 15 mg/d; Week 3: 10 mg/d; Week 4: 5 mg/d, then discontinued after 4 weeks.
Sham acupuncture: Park sham acupuncture device (placebo needle) is used. The acupoint selection and operation sites are the same as those in the treatment group. After routine disinfection, the needle holder is applied to the acupoint, and the needle is inserted into the holder without penetrating the skin, and retained for 20 minutes. The treatment course is the same as the treatment group (3 times per week for 4 weeks).
干预措施: sham acupuncture (Other)
Treatment arm
The treatment group includes two interventions: acupuncture and a steroid placebo (prednisone placebo).
Acupoint selection: Fengchi (GB20, bilateral, quick needling), Jingbailao (bilateral, quick needling), Dazhuipang (bilateral, quick needling); Shenting (DU24), Baihui (DU20), Yingxiang penetrating Bitong (bilateral), Quanliao penetrating Bitong (bilateral), Hegu (LI4, bilateral), Wailaogong (bilateral), Zusanli (ST36, bilateral), Taichong (LR3, bilateral).
Procedure: First, the patient sits upright. Quick needling (without retaining needles) is performed at Fengchi, Jingbailao, and Dazhuipang. Then, the patient assumes a supine position. Needles are inserted Shenting, Baihui, etc.while deep needling is performed at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes.
Course: 3×/week for 4 weeks (12 sessions). Oral prednisone placebo at same dose/duration as control group.
干预措施: Oral Prednisone placebo (Drug)
结局指标
主要结局
Improvement rate of the CSIT score at 4 weeks
时间窗: From enrollment to the end of treatment at 4 weeks
Improvement rate of the CSIT score at 4 weeks.The olfactory identification test is the Chinese Smell Identification Test (CSIT), developed by the Human Olfaction Laboratory, Institute of Psychology, Chinese Academy of Sciences, based on the Chinese population. It contains 40 odor items familiar to the Chinese population and has a 6-month test-retest reliability of 0.92.If the CSIT score improves by 4 points or more, this indicates an improvement in olfactory function.
次要结局
- Improvement rate of the CSIT score at 12 weeks(at 12 weeks after enrollment)
- olfactory threshold scores(From enrollment to the end of treatment at 4 weeks；12 weeks after enrollment)
- subjective olfactory function(From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment)
- Emotional and psychological assessment(From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment)