Effects of acupuncture on heart rate variability in adult tinnitus patients
| ISRCTN | ISRCTN58013563 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58013563 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/06/2012
- Registration date
- 03/09/2012
- Last edited
- 04/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Current plain English summary as of 04/02/2019:
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 evaluate the effect of acupuncture on ANS reactivity in patients with chronic tinnitus.
Who can participate?
Patients aged 18-65 with tinnitus
What does the study involve?
Participants are randomly allocated to be treated with deep acupuncture or shallow acupuncture. 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
Previous 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
Contact information
Scientific
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Current scientific title as of 04/02/2019: Effects of deep acupuncture versus shallow acupuncture on heart rate variability in adult tinnitus patients: an exploratory study Previous scientific title: Effects of hand acupuncture and shallow acupuncture on heart rate variability in adult tinnitus patients: a randomized controlled trial |
| Study hypothesis | Current study hypothesis as of 04/02/2019: This study is aimed to compare the effect of deep acupuncture versus shallow acupuncture on heart rate variability in adult tinnitus patients. Previous 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(s) | Beijing Hospital of Traditional Chinese Medicine & Capital Medical University, 28/02/ 2012 |
| Condition | Tinnitus |
| Intervention | Current interventions as of 04/02/2019: 30 tinnitus patients are randomized to receive deep 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. Previous interventions: 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 |
| Primary outcome measure | 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 study start date | 03/10/2012 |
| Overall study end date | 06/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| 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 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
Study participating centre
100010
China
Sponsor information
Government
70 Zaolinqian Sreet
Xuanwu District
Beijing
100053
China
"ROR" |
https://ror.org/0374a5s68 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 04/02/2019 | 04/02/2019 | No | No |
Additional files
- ISRCTN58013563_BasicResults_4Feb19.pdf
- Uploaded 04/02/2019
Editorial Notes
04/02/2019: The following changes were made:
1. The scientific title was updated.
2. The hypothesis was updated.
3. The interventions were updated.
4. The plain English summary was updated.
5. The basic results of this trial have been uploaded as an additional file.
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.
