Electroacupuncture With or Without Combined Warm Needling for Tinnitus

NCT05557357 | Completed

• 1 other identifier: EAnEAWN-Tinnitus
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Tinnitus; Tinnitus, Subjective

Keywords

Tinnitus; Acupuncture; Moxibustion; Warm Needling; Clinical Trial; Randomized Controlled Trial

Outcome Measures

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.

  Baseline, Week 5, and Week 10

Secondary Outcomes (1)

• Change in Tinnitus Handicap Inventory (THI)

  Baseline, Week 5, and Week 10

Other Outcomes (1)

• Adverse Events

  Up to 10 weeks

Study Arms (3)

EA Group

EXPERIMENTAL

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

Procedure: Electroacupuncture (EA)

EAWN Group

EXPERIMENTAL

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

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.

Other: Waitlist Control

Interventions

Electroacupuncture (EA) 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.

EA Group

Electroacupuncture Combined With Warm Needling (EAWN) 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.

EAWN Group

Waitlist Control OTHER

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

Waitlist Control Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lai Fun HO, PhD: lead
• Chinese University of Hong Kong: collaborator

Study Sites (3)

Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)

Hong Kong, China

Location

Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training ad Research Centre (Yuen Long District)

Hong Kong, China

Location

Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)

Hong Kong, China

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Yuanqi GUO

  Pok Oi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese Medicine Practitioner I

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 28, 2022
• Study Start: December 1, 2022
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)