Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial

N/ANot Yet RecruitingNCT07834047

Beijing Tiantan Hospital84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-traumatic Olfactory Dysfunction

Interventions

AcupunctureOTHER

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: The patient is first seated upright. Quick needling (without needle retention) is performed at Fengchi, Jingbailao, and Dazhuipang. Then the patient assumes a supine position. Needles are inserted at Shenting, Baihui, Wailaogong, and Taichong, while deep needling is applied at Yingxiang penetrating Bitong, Quanliao penetrating Bitong, Hegu, and Zusanli. After achieving deqi (needle sensation), the needles are retained for 20 minutes. Course of treatment: Acupuncture is given 3 times per week for 4 weeks (total 12 sessions)

Corticosteroid therapyDRUG

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 acupunctureOTHER

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).

Oral Prednisone placeboDRUG

The placebo tablets were manufactured to be identical in appearance (color, size, shape) and taste to the active prednisone tablets, ensuring effective blinding. Participants received the placebo orally according to the same tapering regimen as the control group: 30 mg/day (as equivalent tablet count) for week 1, 15 mg/day for week 2, 10 mg/day for week 3, and 5 mg/day for week 4, after which the medication was discontinued. The total course lasted 4 weeks, matching the duration of both the active prednisone therapy and the acupuncture sessions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Improvement rate of the CSIT score 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.

Time frame: From enrollment to the end of treatment at 4 weeks

Secondary Outcomes

Improvement rate of the CSIT score at 12 weeks

Rate of improvement in olfactory identification test scores after 12 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.

Time frame: at 12 weeks after enrollment

olfactory threshold scores

It measures the lowest concentration level that the patient can perceive, assessing sensitivity in detecting odors. It targets the peripheral olfactory nerves. It includes 20 concentration-graded odor sticks (of the same odor) and a baseline odor stick (nearly odorless). The patient smells one graded odor stick and one baseline odor stick sequentially and compares which odor is stronger.

Time frame: From enrollment to the end of treatment at 4 weeks；12 weeks after enrollment

subjective olfactory function

The visual analogue scale (VAS, 0-100) in the olfactory disorder scale was used to rate the severity of olfactory loss, where 0 indicates normal olfaction and 100 indicates complete loss of smell. According to other published studies, the severity of olfactory loss was categorized as mild (0-30), moderate (31-70), and severe (\>70).

Time frame: From enrollment to the end of treatment at 8 weeks;12 weeks after enrollment

Emotional and psychological assessment

Emotional and psychological assessment will be conducted using the Hamilton Anxiety Scale (HAMA), the 17-item Hamilton Depression Scale (HAMD17), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire-9 (PHQ-9) to evaluate patients' emotional and psychological status.