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Acupuncture for Sequelae of Bell's Palsy
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| ISRCTN | ISRCTN43104115 |
| ClinicalTrials.gov identifier | |
| Public title |
Acupuncture for Sequelae of Bell's Palsy
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| Scientific title | Acupuncture for Sequelae of Bell's Palsy: a randomised wait-list controlled pilot trial |
| Acronym | N/A |
| Serial number at source | komc mirb 2010 - 01 |
| 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Kyung-Hee University Medical Center Ethics Committee approved on the 11th of June 2010
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| Study design |
Randomised assessor blind wait list controlled pilot trial
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| Countries of recruitment | Korea, South |
| Disease/condition/study domain |
Sequelae of Bell's palsy
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| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/08/2010 |
| Anticipated end date | 30/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details to request a patient information sheet |
| Target number of participants | 20 participants in experiment group (acupuncture treatment), 10 participants in control group (wait list) |
| Interventions |
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). |
| Primary outcome measure(s) |
Changes in FDI (Facial Disability Index) after 24 sessions/8 weeks of acupuncture treatment.
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| Secondary outcome measure(s) |
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 |
| Sources of funding |
Kyung Hee University (South Korea) - Research Fund in 2010 (KHU-20100699)
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| Trial website | |
| Publications | 1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21388554 |
| Contact name | Prof Jong-In Kim |
| Address |
Dongdaemun-gu
Hoegi-dong #1 Kyung Hee Medical Center |
| City/town | Seoul |
| Zip/Postcode | 130-702 |
| Country | Korea, South |
| hann8400@hanmail.net | |
| Sponsor | Kyung Hee University (South Korea) |
| Address |
Dongdaemun-gu
Hoegi-dong #1 |
| City/town | Seoul |
| Zip/Postcode | 130-701 |
| Country | Korea, South |
| khsa0051@khu.ac.kr | |
| Date applied | 25/06/2010 |
| Last edited | 11/07/2011 |
| Date ISRCTN assigned | 06/07/2010 |
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