Electroacupuncture With or Without Combined Warm Needling for Tinnitus

Tinnitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557357
• Other study ID #: EAnEAWN-Tinnitus
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Pok Oi Hospital
• Contact: Lai Fun HO, PhD
• Phone: (852) 2479 2126
• Email: holaifun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Procedure:
• 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.
• 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.

Other:
• Waitlist Control
No treatment will be provided during the 10-week waiting period after baseline assessment.

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Lai Fun HO, PhD	Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Any adverse event related to study treatment will be recorded and analyzed throughout the study period.	Up to 10 weeks
Primary	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	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