Electroacupuncture With or Without Combined Warm Needling for Tinnitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-04-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation to the Mechanism of the Neuroplastic Modulation in Central Auditory Tract

NCT05591807

Tinnitus Neuromodulation Electroacupuncture +2 more

COMPLETED

The Effect of Acupuncture on Patients With Noise-induced Hearing Loss

NCT05511753

Electroacupuncture Noise Induced Hearing Loss Hearing Loss, Noise-Induced

UNKNOWN NA

The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus

NCT05964725

Tinnitus, Subjective Sudden Deafness Transcranial Direct Current Stimulation +5 more

RECRUITING NA

Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

NCT04449237

Tinnitus, Subjective

UNKNOWN NA

Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus

NCT06364670

Tinnitus

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Tinnitus Tinnitus, Subjective

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EA Group

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

Group Type EXPERIMENTAL

Electroacupuncture (EA)

Intervention Type PROCEDURE

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.

EAWN Group

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

Group Type EXPERIMENTAL

Electroacupuncture Combined With Warm Needling (EAWN)

Intervention Type PROCEDURE

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 Control Group

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

Group Type OTHER

Waitlist Control

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Waitlist Control

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No