Condition category
Ear, Nose and Throat
Date applied
25/06/2012
Date assigned
03/09/2012
Last edited
05/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tinnitus is the term for hearing sounds that come from inside your body rather than from an outside source, often described as "ringing in the ears". Severe tinnitus is associated with anxiety and depression. Hand acupuncture is a system of acupuncture in which the hand is considered to be a representation of the entire body and stimulation of specific points on the hand with needles or lasers is used to obtain effects in distant areas of the body. The aim of this study is to test whether acupuncture can be used to treat tinnitus by comparing the effect of needle and laser acupuncture in adult tinnitus patients.

Who can participate?
Patients aged 18-65 with tinnitus

What does the study involve?
Participants are randomly allocated to be treated with acupuncture using either needles or lasers. Treatment is conducted over a period of 3 weeks, at a frequency of two sessions per week. No additional treatment is allowed. Tinnitus severity and adverse events are assessed in both groups.

What are the possible benefits and risks of participating?
It is possible that acupuncture will help improve tinnitus symptoms but we cannot say this for certain until we have completed this and further studies. Adverse events may include discomfort or bruising at the sites of needle insertion, nausea, or feeling faint.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

When is the study starting and how long is it expected to run for?
October 2012 to October 2013

Who is funding the study?
Beijing health system high-level health technology talent cultivation plan (China)

Who is the main contact?
Dr Cunzhi Liu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cunzhi Liu

ORCID ID

Contact details

23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of hand acupuncture and shallow acupuncture on heart rate variability in adult tinnitus patients: a randomized controlled trial

Acronym

Study hypothesis

This study is aimed to compare the effect of hand acupuncture and shallow acupuncture on heart rate variability in adult tinnitus patients.

Ethics approval

Beijing Hospital of Traditional Chinese Medicine & Capital Medical University, 28/02/ 2012

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tinnitus

Intervention

30 tinnitus patients are randomized to receive hand acupuncture or shallow acupuncture for 3 weeks (twice per week).

Patients are stimulated by 5 main acupoints: Baihui (Du-20), Shenting (Du-24), Tinghui (GB-2), Waiguan (SJ-5), Zulinqi (GB-41). The acupoints are stimulated by the true needles or the laser-needles for 20 minutes per session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Heart rate variability (HRV), measured before and after the first acupuncture session, as well as 3 weeks after the whole acupuncture treatment.

Secondary outcome measures

1. Change of tinnitus severity according to the tinnitus questionnaire of Tinnitus Handicap Inventory (THI):
1.1. F: Functional subscale (11 factors)
1.2. E: Emotional subscale (9 factors)
1.3. C: Catastrophic subscale (5 factors)
Each question of the THI can be answered by the patient with either often (2 points), sometimes (1 point) or never (0 points) with a maximum total score of 100 indicating most severe suffering from tinnitus. The assessment was before and after the first acupuncture session, as well as 3 weeks after the whole acupuncture treatment.
2. Participants also reported adverse events they experienced, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each treatment.

Overall trial start date

03/10/2012

Overall trial end date

06/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Typical conditions of unilateral or bilateral tinnitus
2. Age 18-65 years, either sex
3. Tinnitus duration of more than 3 months
4. Not receive any treatment last 1 month
5. Normal language and intelligence ability to answer and fill in the questionnaire
6. Correct understanding of acupuncture, and good compliance to the research observation and evaluation
7. Written and informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Objectivity tinnitus
2. Acute or intermittent tinnitus, history of Meniere disease or tinnitus induced by middle ear/inner ear/small pons Angle tumor
3. Underlying disease or history: otitis media, tympanic membrane perforation, eustachian tube function obstacle
4. Acoustic neuroma, Intracranial damage, inner ear disease or use of any ototoxic drugs
5. Severe dysfunction of heart, kidneys or liver
6. The serious original disease of hematopoietic system or endocrine system
7. Serious aphasia, depression syndrome or mental disease

Recruitment start date

03/10/2012

Recruitment end date

06/10/2013

Locations

Countries of recruitment

China

Trial participating centre

23 Meishuguanhou Street
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Health Bureau (China)

Sponsor details

70 Zaolinqian Sreet
Xuanwu District
Beijing
100053
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Health System (China) - High Level Health Technology Talent Cultivation Plan ref: 2011-3-055

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/10/2012: the overall trial end date was changed from 12/10/2012 to 06/10/2013. 05/08/2016: Plain English summary added.