Clinical trial NCT05557357: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Tinnitus, Subjective
Keywords: Tinnitus
Acupuncture
Moxibustion
Warm Needling
Clinical Trial
Randomized Controlled Trial
Lead sponsor: Pok Oi Hospital
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2022-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Tinnitus Loudness
timeFrame: Baseline, Week 5, and Week 10
Secondary outcomes:
measure: Change in Tinnitus Handicap Inventory (THI)
timeFrame: Baseline, Week 5, and Week 10
Other outcomes:
measure: Adverse Events
timeFrame: Up to 10 weeks
Locations:
city: Hong Kong
country: China
facility: Pok Oi Hospital-Chinese Medicine Polyclinic (Tin Shui Wai)
city: Hong Kong
country: China
facility: 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
facility: Pok Oi Hospital-The Chinese University of Hong Kong Chinese Medicine Clinic cum Training and Research Centre (Shatin District)
Study officials:
affiliation: Pok Oi Hospital
name: Yuanqi GUO
role: PRINCIPAL_INVESTIGATOR
References: