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Electroacupuncture With or Without Combined Warm Needling for Tinnitus

Primary Purpose

Tinnitus, Tinnitus, Subjective

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture (EA)
Electroacupuncture Combined With Warm Needling (EAWN)
Waitlist Control
Sponsored by
Lai Fun HO, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Acupuncture, Moxibustion, Warm Needling, Clinical Trial, Randomized Controlled Trial

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

EA Group

EAWN Group

Waitlist Control Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2022
Last Updated
April 19, 2023
Sponsor
Lai Fun HO, PhD
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05557357
Brief Title
Electroacupuncture With or Without Combined Warm Needling for Tinnitus
Official Title
Electroacupuncture With or Without Combined Warm Needling for Tinnitus: Study Protocol for A Randomized, Waitlist-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lai Fun HO, PhD
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Tinnitus, Subjective
Keywords
Tinnitus, Acupuncture, Moxibustion, Warm Needling, Clinical Trial, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EA Group
Arm Type
Experimental
Arm Description
Subjects assigned to EA group will receive EA treatment twice weekly for 5 weeks.
Arm Title
EAWN Group
Arm Type
Experimental
Arm Description
Subjects assigned to EAWN group will receive EAWN treatment twice weekly for 5 weeks.
Arm Title
Waitlist Control Group
Arm Type
Other
Arm Description
Subjects assigned to waitlist control group will not receive treatment during the 10-week waiting period after baseline assessment.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture (EA)
Intervention Description
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
Intervention Name(s)
Electroacupuncture Combined With Warm Needling (EAWN)
Intervention Description
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
Other
Intervention Name(s)
Waitlist Control
Intervention Description
No treatment will be provided during the 10-week waiting period after baseline assessment.
Primary Outcome Measure Information:
Title
Change in Tinnitus Loudness
Description
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 Outcome Measure Information:
Title
Change in Tinnitus Handicap Inventory (THI)
Description
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 Pre-specified Outcome Measures:
Title
Adverse Events
Description
Any adverse event related to study treatment will be recorded and analyzed throughout the study period.
Time Frame
Up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lai Fun HO, PhD
Phone
(852) 2479 2126
Email
holaifun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanqi GUO
Organizational Affiliation
Pok Oi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Fun HO, PhD
Facility Name
Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training ad Research Centre (Yuen Long District)
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Fun HO, PhD
Facility Name
Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Fun HO, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Electroacupuncture With or Without Combined Warm Needling for Tinnitus

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