ISRCTN - ISRCTN29230777: Acupuncture at local and distant points for tinnitus

Plain English Summary

Background and study aims
Tinnitus is a term that describes any sound a person can hear from inside their body rather than from an outside source. There is currently no generally accepted explanation of how these phantom sounds come about, and also no effective treatment. Pilot studies have revealed that acupuncture may be used to treat tinnitus. Acupuncture points (acupoints) are locations on the body that are the focus of acupuncture treatment in traditional Chinese medicine. Acupoints located near to the area of the disease (local) and away from the area of the disease (distal) can be needled to treat the disease, and combining these acupoints can make the treatment more effective. The aim of this study is to assess the effects of acupuncture in subjective tinnitus patients.

Who can participate?
Patients aged 18-65 years who have had subjective tinnitus in one or both ears for at least 3 months.

What does the study involve?
Patients will be randomly allocated to one of four treatment groups. Group A will receive acupuncture at local acupoints in combination with distal acupoints. Group B will receive acupuncture at local acupoints in combination with distal non-acupoints (i.e., areas that are not acupoints). Group C will receive acupuncture at local non-acupoints in combination with distal acupoints. Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoints. Participants will receive acupuncture for 4 weeks, at a frequency of two sessions per week. Acupuncture will be performed with sterile needles by a therapist with more than 6 years experience and an acupuncture license from the Ministry of Health of the Peoples Republic of China. No additional treatment will be allowed.

What are the possible benefits and risks of participating?
During the study, you will receive regular check-ups including hearing tests. Acupuncture may help improve your tinnitus but we cannot say this for certain until we have completed this and further research studies.

Where is the study run from?
Acupuncture clinic, 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?
The study started in February 2012 and will run until December 2014.

Who is funding the study?
Beijing Health System (China).

Who is the main contact?
Dr Cun-Zhi Liu
lcz623780@126.com

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

2011-3-055

Study information

Scientific title

Acupuncture at local and distant points for tinnitus: a randomized, blinded, controlled trial

Acronym

Study hypothesis

Evaluate the efficacy of acupuncture at local points in combination with distal points in tinnitus patients.

Ethics approval

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

Study design

Randomized blinded 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

Subjective tinnitus

Intervention

This study is a randomized, single-blind, controlled study. Participants will receive acupuncture at local points in combination with distal points for 4 weeks.

Time points are as follows:
Visit 1: screening
Visit 2: treatment initiation, participants will receive acupuncture for 4 weeks
Visit 3: 4 weeks after first acupuncture, follow-up and treatment finish
Visit 4: 8 weeks after first acupuncture, follow-up

Patients who met the inclusion criteria and none of the exclusion criteria were randomized to one of four treatment groups:
Group A will receive acupuncture at local acupoints in combination with distal acupoints.
Group B will receive acupuncture at local acupoints in combination with distal non-acupoints.
Group C will receive acupuncture at local non-acupoints in combination with distal acupoints.
Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoints.

Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Subjective tinnitus loudness and annoyance perception was graded using the Visual Analogue Scale (VAS). The assessment was at baseline (before treatment initiation), 4 weeks after the first acupuncture and 8 weeks after the first acupuncture.

Secondary outcome measures

1. Change of tinnitus severity according to the tinnitus questionnaire of the 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 at baseline (before treatment initiation), 4 weeks after the first acupuncture and 8 weeks after the first acupuncture.
2. Changes of tone and noise parameters of tinnitus, assessed by tinnitus matching (screening versus week 8) at 4 and 8 weeks after the first acupuncture, follow up.
3. Perceived Credibility of acupuncture was evaluated by The Treatment Credibility Scale (TCS) after a 4-week acupuncture session. It is a 5-item questionnaire ranging from 1 (not at all) to 5 (very confident); items were averaged to provide a single treatment credibility score, with high scores reflecting high treatment credibility.
4. To evaluate the adequacy of blinding, we asked participants to rate how certain they were that they had received traditional acupuncture or a new method of acupuncture on a 7-point scale (1 very sure, 7 very uncertain) after 4 weeks of treatment.
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

03/03/2012

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of subjective tinnitus, unilateral or bilateral
2. Age 18-65 years, either sex
3. Tinnitus duration of at least 3 months
4. Agreed not to receive another treatment during the clinical trial period
5. Written and informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

Participant exclusion criteria

1. Objective tinnitus
2. Underlying disease or history:
2.1. Otitis media
2.2. Acoustic tumour
2.3. Intracranial lesion
2.4. Inner ear malformation
2.5. Head trauma
2.6. Ototoxic drug medication
3. Women in pregnacy and lactation or without contraception
4. History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder, blood transfusion affecting the brain or prior brain surgery
5. Inability to correct use of test equipment: unable to cooperate during audiologic examination
6. Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the trial

Recruitment start date

03/03/2012

Recruitment end date

31/12/2014

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

http://english.bjhb.gov.cn/

Funders

Funder type