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临床试验/NCT06544434
NCT06544434招募中2 期

Laser Acupuncture for Meniere Disease: A Randomized Controlled Trial

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
324
试验地点
1
主要终点
Tinnitus Handicap Inventory (THI)

研究概览

简要总结

Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease.

Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of meniere disease.

排除标准

  • Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
  • Planning for pregnancy, those in pregnancy, or those who were lactating.

研究组 & 干预措施

Laser acupuncture 3 month Group

Experimental

干预措施: Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy) (Device)

Laser acupuncture 3 month Group

Experimental

干预措施: Betahistine Mesylate tablet (Drug)

Sham acupuncture Group

Sham Comparator

干预措施: Multiwave Locked System (MLS) laser (Mphi laser, ASA Srl, Vicenza, Italy) (Device)

Sham acupuncture Group

Sham Comparator

干预措施: Betahistine Mesylate tablet (Drug)

Control Group

Other

干预措施: Betahistine Mesylate tablet (Drug)

结局指标

主要结局

Tinnitus Handicap Inventory (THI)

时间窗: Baseline, month 3, 6 and 12

The THI is a 25-items, self-reported questionnaire regarding tinnitus handicap in daily life. The questionnaire comprises a 12-item functional subscale, an 8-item emotional subscale, and a 5-item catastrophic subscale. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of tinnitus symptoms.

Dizziness Handicap Inventory (DHI)

时间窗: Baseline, month 3, 6 and 12

The DHI is 25-items self-reported questionnaire that used to evaluate the functional, emotional, and physical impact of dizziness on patients' daily life. Among the overall 25 items of questions, 9 items are emotional related, 9 items are functional related, and 7 items are physical related questions. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of dizziness symptoms.

Pure tone thresholds (PTA)

时间窗: Baseline, month 3, 6 and 12

The pure tone thresholds was performed in a sound-attenuated, double-walled booth with circumaural headphones (Sennheiser HD 280 for frequencies from 250 to 8000 Hz and Sennheiser HD 200 for frequencies from 8000 to 14000 Hz; Sennheiser, Old Lyme, USA) on a certified and calibrated audiometric system (Interacoustics, Middelfart, Denmark). Thresholds were measured using a probe-detection paradigm with pure tones presented for 250 ms at frequencies of 250, 500, 1000, 2000, 4000, 8000 Hz for each ear. To determine the LDL, the volume was set to 75 dB at 1000 Hz and then continuously raised in 5 dB steps (every 5 s) until the subject gave the signal that this volume was uncomfortable. When the volume exceeded 110 dB the test was stopped to prevent any hearing damage. The severity of hearing impairment was calculated as mild (20-40 dB), moderate (41-70 dB), severe (71-95 dB) and profound (\>95 dB). Normal hearing was defined as pure-tone thresholds less than 20 dB.

Visual analogue scale (VAS)

时间窗: Baseline, month 3, 6 and 12

The VAS scale of aural fullness consists of a 100 mm straight line with defined endpoints ("no aural fullness" and "worst aural fullness imaginable") on which the patients were asked to mark their experienced aural fullness (results in mm) at the actual time ("VAS now"). The higher VAS score (Range: 0-100) is correlated with a severe aural fullness.

次要结局

  • The Caloric Test(Baseline, month 3, 6 and 12)
  • Video head impulse test (vHIT)(Baseline, month 3, 6 and 12)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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