Electroacupuncture With or Without Combined Warm Needling for Tinnitus

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.

Study Overview

• Status: Recruiting
• Conditions: Tinnitus, Subjective; Tinnitus
• Intervention / Treatment: Procedure: Electroacupuncture (EA); Procedure: Electroacupuncture Combined With Warm Needling (EAWN); Other: Waitlist Control

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lai Fun HO, PhD; Phone Number: (852) 2479 2126; Email: holaifun@gmail.com

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)
    • Contact: Lai Fun HO, PhD
  • Hong Kong, China
    • Recruiting
    • Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training ad Research Centre (Yuen Long District)
    • Contact: Lai Fun HO, PhD
  • Hong Kong, China
    • Recruiting
    • Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)
    • Contact: Lai Fun HO, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EA Group; Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks.	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.
Experimental: EAWN Group; Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks.	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.
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; No treatment will be provided during the 10-week waiting period after baseline assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Any adverse event related to study treatment will be recorded and analyzed throughout the study period.	Up to 10 weeks

Collaborators and Investigators

• Sponsor: Lai Fun HO, PhD
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Yuanqi GUO, Pok Oi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: September 25, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Acupuncture; Randomized Controlled Trial; Clinical Trial; Tinnitus; Moxibustion; Warm Needling
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: EAnEAWN-Tinnitus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No