Efficacy and safety of acupuncture for chronic dizziness
| ISRCTN | ISRCTN52695239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52695239 |
| Secondary identifying numbers | 20113055 |
- Submission date
- 25/03/2013
- Registration date
- 25/06/2013
- Last edited
- 20/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Dizziness is one of the most challenging symptoms in medicine. The annual prevalence of dizziness in the adult population is 22.9% as reported in Germany. Over 66 % of dizzy patients experience psychological distress, often resulting in a vicious cycle of fear, avoiding movements that might make them feel dizzy, and increased handicap, slowing down recovery even further. Research shows that no medication in current use has well-established cure or is suitable for long-term use. Non-traditional remedies should be considered and scientifically studied. Acupuncture, which is one of the main treatment methods of traditional Chinese medicine (TCM), has been used for both prevention and treatment of dizziness for over three thousand years. Many studies have investigated the benefits and success of acupuncture in easing symptoms for various diseases. Thus, the purpose of this study is to determine how good acupuncture is in patients with chronic dizziness.
Who can participate?
Participants (both male and female) should be aged 18-75 years. Any patient with chronic dizziness, diagnosed by physicians and then referred to acupuncture department, is eligible for the study.
What does the study involve?
Two hundred patients are randomly assigned to one of the two study groups, group A (treatment group) receives acupuncture therapy or group B (control group) receives sham-acupuncture therapy. Patients in group A receive acupuncture on Baihui, Yintang, Taiyang, Wangu, Tinggong, Fengchi, Hegu, Fenglong and Taichong. Group B will receive shallow needle insertion that does not penetrate below the skin (minimal or superficial needling) at non-acupoints. The acupuncturist has an acupuncture license (Chinese medicine practitioner license) from the Ministry of Health of the Peoples Republic of China and takes an educational course to ensure that they strictly follow the study method and are familiar with conducting the study.
What are the possible benefits and risks of participating?
One of the most important benefits is finding out effective and safe treatment for patients with dizziness, especially those who do not respond to medical therapy or those who suffer from side-effects of drug therapy. The risks of taking part are minimal. Acupuncture is a very safe treatment when given by properly trained clinicians. Occasionally acupuncture can make people feel nauseous or faint or have blood clot beneath the skin. Participants are warned of these potential side-effects before consenting to have acupuncture.
Where is the study run from?
The study is carried out at the Acupuncture Department of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University in Beijing, China.
When is the study starting and how long is it expected to run for?
We started recruiting participants into the study in February 2012, with enrolment continuing until December 2015.
Who is funding the study?
Beijing Health System (China) - High Level Health Technology Talent Cultivation Plan ref: 2011-3-055
Who is the main contact?
Dr Liu Cun-zhi
lcz623780@126.com
Contact information
Scientific
23 Meishuguanhou Street, Dongcheng District
Beijing
100010
China
Study information
| Study design | Randomized blinded 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 | Efficacy and safety of acupuncture for chronic dizziness: a randomized controlled clinical trial |
| Study hypothesis | There has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. This trial is to evaluate the efficacy of acupuncture in chronic dizziness patients in comparison to sham-acupuncture. On 16/09/2013, the target number of participants was changed from 80 to 100. |
| Ethics approval(s) | Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine, 22/03/2013, ref: 201316 |
| Condition | Chronic dizziness |
| Intervention | The 80 chronic dizziness sufferers are randomly allocated to two different groups: 1. Treatment group: At least two acupuncture sessions per week for 4 weeks. 2. Control group: At least two sham-acupuncture sessions per week for 4 weeks. Each acupuncture session lasts for 30 min. |
| Intervention type | Other |
| Primary outcome measure | 1. Vertigo Symptom Scale (VSS) to assess the frequency of dizziness-related symptom; 2. Dizziness Handicap Inventory (DHI) to evaluate the functional, emotional and physical impact of dizziness on patients daily life. The outcome measures above will be assessed at baseline (before treatment initiation), 4 weeks later of the first acupuncture, and 8 weeks later of the first acupuncture. |
| Secondary outcome measures | 1. Short Form-36 quality-of-life questionnaire to evaluate a persons health perception in daily life at baseline (before treatment initiation), 4 weeks later of the first acupuncture, and 8 weeks later of the first acupuncture. 2. Hospital Anxiety and Depression Scale to assess non-somatic symptoms of anxiety and depression at baseline (before treatment initiation), 4 weeks later of the first acupuncture, and 8 weeks later of the first acupuncture. 3. Perceived Credibility of acupuncture is 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 are averaged to provide a single treatment credibility score, with high scores reflecting high treatment credibility. 4. To evaluate the adequacy of blinding, we will ask participants to rate how certain they are that they have received traditional acupuncture or new method of acupuncture on a 7-point scale (1 very sure, 7 very uncertain) after 4 weeks of treatment. Participants will also report adverse events they experience, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each treatment. |
| Overall study start date | 28/02/2013 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | Current inclusion criteria as of 16/09/2013: 1. Vertigo of unknown cause 2. Dizziness of unknown cause 3. Meniere's disease 4. Psychogenic dizziness 5. Age 18 to 75 years, either sex Previous inclusion criteria: 1. Vertigo of unknown cause 2. Dizziness of unknown cause 3. Meniere's disease 4. Cervicogenic dizziness 6. Vestibular imbalance or disorder 8. Otologic disorder 9. Psychogenic dizziness 10. Age 18 to 75 years, either sex 11. Written and informed consent |
| Participant exclusion criteria | 1. Labyrinthitis 2. Benign positional vertigo 3. Vestibular neuronitis 4. Duration of dizziness less than 2 months the past 2 years 5. Serious comorbid conditions (for example, life-threatening condition or progressive central disorder) 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 | 28/02/2013 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- China
Study participating centre
100010
China
Sponsor information
Government
70 Zaolinqian Sreet Xuanwu District
Beijing
100053
China
| Website | http://english.bjhb.gov.cn/ |
|---|---|
"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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/12/2013 | Yes | No | |
| Basic results | 15/02/2019 | 20/02/2019 | No | No |
Additional files
- ISRCTN52695239_BasicResults_15Feb19.pdf
- Uploaded 20/02/2019
Editorial Notes
20/02/2019: The basic results summary of this trial have been uploaded as an additional file.
