Acupuncture for Sequelae of Bell's Palsy
| ISRCTN | ISRCTN43104115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43104115 |
| Secondary identifying numbers | komc mirb 2010 - 01 |
- Submission date
- 25/06/2010
- Registration date
- 06/07/2010
- Last edited
- 04/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Jong-In Kim
Scientific
Scientific
Dongdaemun-gu
Hoegi-dong #1
Kyung Hee Medical Center
Seoul
130-702
Korea, South
| hann8400@hanmail.net |
Study information
| Study design | Randomised assessor blind wait list controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Acupuncture for Sequelae of Bell's Palsy: a randomised wait-list controlled pilot trial |
| Study hypothesis | The primary objective of the present protocol is to investigate the effectiveness of acupuncture in patients with sequelae of Bell's palsy, compared to a no-acupuncture waitlist status. |
| Ethics approval(s) | Kyung-Hee University Medical Center Ethics Committee, 11/06/2010 |
| Condition | Sequelae of Bell's palsy |
| Intervention | The study includes the following periods in all groups: a treatment period of 8 weeks (3 sessions/week), and a follow-up period of 4 weeks. Acupuncture group: In the acupuncture treatment group, 18 acupuncture points (ipsilateral ST4, ST6 on the unaffected side, ipsilateral ST1, EX-HN4, TE23, LI20 on the affected side, and bilateral TE17, ST9, LI10, LI4, ST36, GB34) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 5 - 10 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes. Waitlist: Participants who will be allocated to waitlist will receive no acupuncture treatment throughout the 8 weeks. After 8 weeks, if participants elect to try the acupuncture treatment it will be provided, acupuncture treatment period of 8 weeks (3 sessions/week). |
| Intervention type | Other |
| Primary outcome measure | Changes in FDI (Facial Disability Index) after 24 sessions/8 weeks of acupuncture treatment. |
| Secondary outcome measures | Changes in the following, after 24 sessions/8 weeks of acupuncture treatment and one-month follow-up: 1. Sunnybrook Facial Grading System 2. H-B Scale 3. Lip-length and snout indices 4. Facial stiffness |
| Overall study start date | 01/08/2010 |
| Overall study end date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 participants in experiment group (acupuncture treatment), 10 participants in control group (wait list) |
| Participant inclusion criteria | 1. Aged between 18-65 2. Diagnosis of Bell's palsy (ICD-10 G51.0), at least 6 months prior to recruitment 3. FDI (Facial Disability Index) score of below 70 in Physical Function, and below 80 in Social/Well-being Function 4. Provided written informed consent |
| Participant exclusion criteria | 1. Secondary facial palsy resulting from specific disease such as infection, multiple neuritis, tumour invading the temporal region, cerebral contusion or stroke 2. Patient manifesting Ramsay-Hunt syndrome 3. Bilateral facial palsy 4. Recurred facial palsy 5. Received orally administered corticosteroids or anti-viral agent(aciclovir, valaciclovir, famciclovir, ganciclovir) within 1 month before enrolment 6. Received alternative and complementary modality, i.e. acupuncture, moxibustion, vesicant therapy or massage for treating Bell's palsy within 3 months 7. Received operation, i.e. facial nerve decompression, facial nerve and muscle reconstruction for treating Bell's palsy 8. Suffering serious medical condition such as uncontrolled hypertension, diabetes mellitus requiring insulin injection, past or current malignant tumour, severe dyslipidemia or liver and kidney dysfunction, anaemia, active pulmonary tuberculosis, other infectious disease or systemic diseases insufficient for acupuncture treatment 9. Other neurologic illness 10. Participating in another clinical trial 11. Suffering psychiatric illness insufficient for participation in clinical trial 12. Unable to obtain written consent 13. Pregnant or nursing status, or planning conception during treatment 14. Scar in administration area or systemic illness unsuitable for acupuncture treatment in the judgement of the investigator |
| Recruitment start date | 01/08/2010 |
| Recruitment end date | 30/04/2011 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Dongdaemun-gu
Seoul
130-702
Korea, South
130-702
Korea, South
Sponsor information
Kyung Hee University (South Korea)
University/education
University/education
Dongdaemun-gu
Hoegi-dong #1
Seoul
130-701
Korea, South
| khsa0051@khu.ac.kr | |
"ROR" |
https://ror.org/01zqcg218 |
Funders
Funder type
University/education
Kyung Hee University (South Korea) - Research Fund in 2010 (KHU-20100699)
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 | 09/03/2011 | Yes | No | |
| Results article | results | 03/06/2015 | Yes | No |
