Electroacupuncture With or Without Combined Warm Needling for Tinnitus

Study Overview
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Brief Summary
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This randomized controlled trial aims to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling in reducing tinnitus loudness and improving the impairment caused by tinnitus in Hong Kong.

Detailed Description
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This study is a prospective, multicenter, assessor-blind, three-arm, parallel-group, randomized waitlist-controlled trial. A total of 90 eligible subjects with tinnitus will be recruited and randomly assigned to electroacupuncture (EA), electroacupuncture combined with warm needling (EAWN) or waitlist control with n=30 subjects each group. The entire study period will last for 10 weeks, including a 5-week intervention period and a 5-week follow-up period. Outcome measures include the loudness of tinnitus and the Tinnitus Handicap Inventory. Any adverse event will be observed and recorded for safety assessment. The study findings will provide evidence to determine the efficacy and safety of electroacupuncture with or without combined warm needling for tinnitus in Hong Kong.

Official Title
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Electroacupuncture With or Without Combined Warm Needling for Tinnitus: Study Protocol for A Randomized, Waitlist-controlled Trial

Conditions
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Tinnitus, Tinnitus, Subjective

Intervention / Treatment
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* Procedure: Electroacupuncture (EA)
* Procedure: Electroacupuncture Combined With Warm Needling (EAWN)
* Other: Waitlist Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with subjective tinnitus; Male and female, age 50 to 70 years old; Unilateral or bilateral tinnitus for 0.5-24 months; Loudness of tinnitus rated 3 points or more on a 0-10 numeric rating scale (NRS) at the time of enrollment; and Agree to sign the informed consent form voluntarily. Exclusion Criteria: Known disease conditions that could cause tinnitus such as Meniere's syndrome, acoustic duct diseases, and middle ear diseases; History of head trauma; Currently using cardiac pacemaker or metal implants; Known severe cardiac diseases, cerebrovascular diseases, renal diseases, or hematologic diseases; Known severe psychiatric or psychological disorder; Pregnant, lactation or expecting a pregnancy during the study period; Severe needle phobia; Known hypersensitive reaction after acupuncture and moxibustion treatment or an inability to cooperate with the acupuncture and moxibustion procedure; Incapable to understand and answer the questions of the assessors in the study; and Other factors deemed unsuitable for inclusion in the study by investigators.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA Group<br>Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks. | Procedure: Electroacupuncture (EA)<br>* Electroacupuncture (EA) treatment following standardized procedures will be conducted for 2 sessions per week for 5 consecutive weeks. Each session of treatment will last for 25 min. The acupoints that will be stimulated are Tinggong (SI19) and Yifeng (TE17) of the affected side, Baihui (GV20) and Yintang (GV24+), bilateral posterior temporal line (MS11), and Zhongzhu (TE3) and Zusanli (ST36) of the affected side. For electroacupuncture (EA), electrical stimulation will be applied using an EA apparatus, with pairs of electrodes connecting the needles at ipsilateral SI19 and TE17, GV20 and GV24+, and bilateral MS11.<br>|
| Experimental: EAWN Group<br>Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks. | Procedure: Electroacupuncture Combined With Warm Needling (EAWN)<br>* Electroacupuncture combined with warm needling (EAWN) treatment following standardized procedures will be conducted for 2 sessions per week for 5 consecutive weeks. Each session of treatment will last for 25 min. The acupoints that will be stimulated are SI19 and TE17 (affected side), GV20 and GV24+, bilateral MS11, and TE3 and ST36 (affected side). For electroacupuncture (EA), electrical stimulation will be applied using an EA apparatus, with pairs of electrodes connecting the needles at ipsilateral SI19 and TE17, GV20 and GV24+, and bilateral MS11. For warm needling (WN), two moxa sticks will be ignited and attached one by one to the needle handle of each acupoint of SI19 and TE17.<br>|
| Other: Waitlist Control Group<br>Subjects assigned to waitlist control group will not receive treatment during the 10-week waiting period after baseline assessment. | Other: Waitlist Control<br>* No treatment will be provided during the 10-week waiting period after baseline assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Loudness | A 0-10 numeric rating scale (NRS) will be used for rating loudness of tinnitus. Higher score indicates greater tinnitus loudness and its influence. | Baseline, Week 5, and Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Handicap Inventory (THI) | THI is a 25-item self-report measure to determine tinnitus handicap severity with good reliability and validity. The THI total score ranges from 0 to 100, with higher score denoting higher level of severity. | Baseline, Week 5, and Week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinnitus, Acupuncture, Moxibustion, Warm Needling, Clinical Trial, Randomized Controlled Trial