TinnitusNCT05557357
Electroacupuncture With or Without Combined Warm Needling for Tinnitus
A study testing Electroacupuncture (EA) and Electroacupuncture Combined With Warm Needling (EAWN) in people with Tinnitus and Tinnitus, Subjective, run by Lai Fun HO, PhD at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- Electroacupuncture (EA) and Electroacupuncture Combined With Warm Needling (EAWN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2022to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)
Hong Kong
Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training ad Research Centre (Yuen Long District)
Hong Kong
Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)
Hong Kong
About this study
Official title: Electroacupuncture With or Without Combined Warm Needling for Tinnitus: Study Protocol for A Randomized, Waitlist-controlled Trial
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.
Read the detailed description
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.
- Conditions
- Tinnitus, Tinnitus, Subjective
- Being tested
- Electroacupuncture (EA), Electroacupuncture Combined With Warm Needling (EAWN), Waitlist Control
- Keywords
- Tinnitus, Acupuncture, Moxibustion, Warm Needling, Clinical Trial, Randomized Controlled Trial
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture (EA)Procedure or surgery
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.
Electroacupuncture Combined With Warm Needling (EAWN)Procedure or surgery
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.
Waitlist ControlOther
No treatment will be provided during the 10-week waiting period after baseline assessment.
| Study group | Role | What they receive |
|---|---|---|
| EA Group | Experimental | Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks. Receives: Procedure: Electroacupuncture (EA) |
| EAWN Group | Experimental | Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks. Receives: Procedure: Electroacupuncture Combined With Warm Needling (EAWN) |
| Waitlist Control Group | Other | Subjects assigned to waitlist control group will not receive treatment during the 10-week waiting period after baseline assessment. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 5, and Week 10
Secondary outcomes (1)
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.
Measured: Baseline, Week 5, and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Dec 2022
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lai Fun HO, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor-investigator, Lai Fun HO, PhD, Pok Oi Hospital
- Investigators
- Yuanqi GUO, Principal investigator, Pok Oi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557357
- Sponsor's protocol ID
- EAnEAWN-Tinnitus
- Status last verified
- May 2025
- First submitted
- 18 Sep 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture With or Without Combined Warm Needling for Tinnitus: Study Protocol for A Randomized, Waitlist-controlled Trial
- ClinicalTrials.gov ID
- NCT05557357
- Acronym / sponsor ID
- EAnEAWN-Tinnitus
- Conditions
- Tinnitus, Tinnitus, Subjective
- Keywords
- Tinnitus, Acupuncture, Moxibustion, Warm Needling, Clinical Trial, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lai Fun HO, PhDUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EA Group | Experimental | Procedure: Electroacupuncture (EA)Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks. |
| EAWN Group | Experimental | Procedure: Electroacupuncture Combined With Warm Needling (EAWN)Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks. |
| Waitlist Control Group | Other | Other: Waitlist ControlSubjects assigned to waitlist control group will not receive treatment during the 10-week waiting period after baseline assessment. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture (EA)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. | Procedure or surgery | EA Group |
| Electroacupuncture Combined With Warm Needling (EAWN)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. | Procedure or surgery | EAWN Group |
| Waitlist ControlNo treatment will be provided during the 10-week waiting period after baseline assessment. | Other | Waitlist Control Group |
Primary outcome
Change in Tinnitus Loudness
Time frame: Baseline, Week 5, and Week 10
A 0-10 numeric rating scale (NRS) will be used for rating loudness of tinnitus. Higher score indicates greater tinnitus loudness and its influence.
1 secondary outcome
Change in Tinnitus Handicap Inventory (THI)
Time frame: Baseline, Week 5, and Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanqi GUO principal investigator
Pok Oi Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture (EA) and Electroacupuncture Combined With Warm Needling (EAWN) in people with Tinnitus and Tinnitus, Subjective, run by Lai Fun HO, PhD at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Loudness (time frame: Baseline, Week 5, and Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.