Condition category
Nervous System Diseases
Date applied
25/06/2010
Date assigned
06/07/2010
Last edited
04/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jong-In Kim

ORCID ID

Contact details

Dongdaemun-gu
Hoegi-dong #1
Kyung Hee Medical Center
Seoul
130-702
Korea
South
-
hann8400@hanmail.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

komc mirb 2010 - 01

Study information

Scientific title

Acupuncture for Sequelae of Bell's Palsy: a randomised wait-list controlled pilot trial

Acronym

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

Kyung-Hee University Medical Center Ethics Committee, 11/06/2010

Study design

Randomised assessor blind wait list controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 participants in experiment group (acupuncture treatment), 10 participants in control group (wait list)

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

Trial participating centre

Dongdaemun-gu
Seoul
130-702
Korea, South

Sponsor information

Organisation

Kyung Hee University (South Korea)

Sponsor details

Dongdaemun-gu
Hoegi-dong #1
Seoul
130-701
Korea
South
-
khsa0051@khu.ac.kr

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Kyung Hee University (South Korea) - Research Fund in 2010 (KHU-20100699)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21388554
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26037730

Publication citations

  1. Protocol

    Kwon HJ, Kim JI, Lee MS, Choi JY, Kang S, Chung JY, Kim YJ, Lee SH, Lee S, Nam D, Kim YS, Lee JD, Choi DY, Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol., Trials, 2011, 12, 71, doi: 10.1186/1745-6215-12-71.

  2. Results

    Kwon HJ, Choi JY, Lee MS, Kim YS, Shin BC, Kim JI, Acupuncture for the sequelae of Bell's palsy: a randomized controlled trial, Trials, 2015 , 16, 1, 246, doi: 10.1186/s13063-015-0777-z.

Additional files

Editorial Notes