The Efficacy of Acupuncture and Moxibustion in Urination Disorders after Stroke
| ISRCTN | ISRCTN97151578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97151578 |
| Secondary identifying numbers | D08050703550902 |
- Submission date
- 24/09/2010
- Registration date
- 19/10/2010
- Last edited
- 19/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Linpeng Wang
Scientific
Scientific
Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie
Dongcheng Dis.
Beijing
100010
China
| Phone | +86 (0)10 5217 6636 |
|---|---|
| wlp5558@sina.com |
Study information
| Study design | Multicentre randomised single blind controlled study |
|---|---|
| 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 contact shizheng83@hotmail.com to request a patient information sheet |
| Scientific title | The effect of both acupuncture and moxibustion versus standard Western therapy in reducing the rate of deformity of stroke and in improving the symptoms of urination disorders after stroke in adult patients: a multicentre randomised controlled trial |
| Study acronym | EAMUDS |
| Study objectives | Stroke can lead to the urination disorders, for instance, urinary incontinence, urgency of urination and urinary frequency. Urination disorders may severely influence the patients' quality of life and contribute to the burden of medical care. This study is to explore the acupuncture and moxibustion in improving the symptoms of urination disorders after stroke and the quality of the patients' lives. |
| Ethics approval(s) | Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine approved on the 22nd January 2010 (ref: 201002-1) |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | A total of 120 patients in the recovery stage of cerebral apoplexy will be recruited. All of the 120 patients are from the Acupuncture Department of Beijing Huguosi Chinese Medicine Hospital and the Acupuncture Department of Beijing Hospital of Traditional Chinese Medicine. 60 patients fit the description for the syndrome of deficiency of kidney-yang and 60 patients fit the description for the syndrome of deficiency of qi. 1. The patients with the syndrome of deficiency of kidney-yang were randomly divided into two different groups with the ratio of 2:1. 1.1.The experimental group (A) received the acupuncture and moxibustion remedy for 4 weeks: Cut the fresh ginger into slices (thickness 6-7mm, diameter 40-50mm), pierce several holes on the ginger. Put the mugwort floss (height 30mm, diameter 30mm, column) on the slices of gingers. Fill the salt in Shenque (RN-8) and place the slice of ginger on Shenque, light the mugwort floss, until it burnout, for 3 zhuangs, once a day, five days a week. 1.2. The patients of the controlled group (B) wait for 4 weeks with no therapy. 2. The patients with the syndrome of deficiency of qi were randomly divided into two different groups with a ratio of 2:1. 2.1. The experimental group (C) received the electro acupuncture remedy for 4 weeks: Needling Ciliao (BL-31) and Huiyang (BL-35), on both sides of the body. Oblique insertion into the 2nd posterior sacral foramina to depth of 80mm, with electrified needling sensation to external genitalia. Perpendicular needling in Huiyang, if a sore and distended needling response then lift the needles a little, link up the electric impulse acupuncture units, choose frequency 50 hz. Gently adjust the frequency as much as the patients can endure, apply the needles for 30 minutes, once a day, five days a week. 2.2. The patients of the controlled group (D) wait for 4 weeks with no therapy. Joint Sponsor: Beijing Hospital of Traditional Chinese Medicine (China) No. 23 Meishuguanhoujie Dongcheng District Beijing 100010 China T: +86 (0)10 5217 6852 F: +86 (0)10 5217 6808 Email: postmaster@bjzhongyi.com Website: http://www.bjzhongyi.com |
| Intervention type | Other |
| Primary outcome measure | The number of incontinence and normal micturition episodes in 72 hours. Assessed by a micturition diary over 4 weeks. |
| Secondary outcome measures | 1. Questionnaire of Overactive bladder (OAB) and incontinence at 4 weeks 2. Urinary incontinence grade score at 4 weeks 3. Quality of life assessment (Barthel Index) at 4 weeks |
| Overall study start date | 01/08/2009 |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Stroke Patients diagnosed according to criteria of cerebral arterial thrombosis in Western medicine and the criteria of apoplexy in Chinese medicine 2. Inpatients who suffered a stroke in the previous 4-24 weeks 3. Male or female, aged 40-70 4. Fit the description for the syndrome of deficiency of kidney-yang or the syndrome of deficiency of qi 5. Urination disorders occuring after the stroke, and the patients' condition is stable 5.1. Patients that suffer from urinary incontinence; or 5.2. No urinary incontinence but with serious urgency of urination and increased urinary frequency 6. Patients with no disorder of consciousness, no barriers to communication 7. Patients with normal cognitive function |
| Key exclusion criteria | 1. Patients with severe primary diseases of the cardiovascular system, liver, kidney, hematopoietic system, psychopathy or late stage tumor 2. Patients with chronic retention of urine, urinary incontinence, urgency of urination and high frequency of urination before the stroke 3. Patients suffering from chronic urinary infection 4. Patients suffering from serious anepia, difficulty communicating or severe cognitive disorder which may result in urination disorder 5. Female with stress incontinence |
| Date of first enrolment | 01/08/2009 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing Hospital of Traditional Chinese Medicine
Beijing
100010
China
100010
China
Sponsor information
Beijing Municipal Science and Technology Commission (China)
Not defined
Not defined
No. 16 Xizhimendajie
Xicheng Dis.
Beijing
100035
China
| Phone | +86 (0)10 6615 3395 |
|---|---|
| bjkwwz@sina.com | |
| Website | http://www.bjkw.gov.cn/n1143/index.html |
"ROR" |
https://ror.org/034k14f91 |
Funders
Funder type
Hospital/treatment centre
Beijing Municipal Science and Technology Commission (China)
No information available
Beijing Hospital of Traditional Chinese Medicine (China)
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 |
