Electroacupuncture With or Without Combined Warm Needling for Tinnitus: Study Protocol for A Randomized, Waitlist-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- Lai Fun HO, PhD
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Change in Tinnitus Loudness
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Lai Fun HO, PhD
Chinese Medicine Practitioner I
Pok Oi Hospital
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.
Outcomes
Primary Outcomes
Change in Tinnitus Loudness
Time Frame: Baseline, Week 5, and Week 10
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 Outcomes
- Change in Tinnitus Handicap Inventory (THI)(Baseline, Week 5, and Week 10)