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CompletedNCT05557357Updated May 25, 2025

Electroacupuncture With or Without Combined Warm Needling for Tinnitus

An interventional study of Electroacupuncture (EA) and Electroacupuncture Combined With Warm Needling (EAWN) in Tinnitus and Tinnitus, Subjective, sponsored by Lai Fun HO, PhD. Completed at 3 sites in China. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Lai Fun HO, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tinnitus
  • Tinnitus, Subjective

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Keywords

  • Tinnitus
  • Acupuncture
  • Moxibustion
  • Warm Needling
  • Clinical Trial
  • Randomized Controlled Trial
03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

This is the only study on the registry with Lai Fun HO, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    EA Group

    Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks.

    Procedure: Electroacupuncture (EA)

  • Experimental
    EAWN Group

    Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks.

    Procedure: Electroacupuncture Combined With Warm Needling (EAWN)

  • Other
    Waitlist Control Group

    Subjects assigned to waitlist control group will not receive treatment during the 10-week waiting period after baseline assessment.

    Other: Waitlist Control

Interventions

  • ProcedureElectroacupuncture (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.

  • ProcedureElectroacupuncture 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.

  • OtherWaitlist Control

    No treatment will be provided during the 10-week waiting period after baseline assessment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, Week 5, and Week 10

Other outcomes

  1. Adverse Events

    Any adverse event related to study treatment will be recorded and analyzed throughout the study period.

    Time frame: Up to 10 weeks

07

Study locations

3 sites
  • Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)
    Hong Kong, China
  • Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training ad Research Centre (Yuen Long District)
    Hong Kong, China
  • Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)
    Hong Kong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05557357
Lead sponsor
Lai Fun HO, PhD
Collaborators
Chinese University of Hong Kong
Responsible party
Lai Fun HO, PhD (Chinese Medicine Practitioner I, Pok Oi Hospital) — Sponsor-investigator
First posted
Sep 28, 2022
Start date
Dec 1, 2022
Primary completion
Apr 12, 2024
Completion
Apr 12, 2024
Last update
May 25, 2025

Study contacts

Yuanqi GUO
principal investigator · Pok Oi Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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