Electrical muscle stimulation for Bell's palsy (sudden weakness in the muscles on one side of the face)
| ISRCTN | ISRCTN14974687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14974687 |
| Secondary identifying numbers | 30/17 |
- Submission date
- 21/02/2023
- Registration date
- 27/02/2023
- Last edited
- 08/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Bell's palsy is sudden weakness in the muscles on one side of the face. The aim of this study is to explore whether selective electrical muscle stimulation could shorten the time to recovery of facial paralysis.
Who can participate?
Adults (aged 18 years or above) with a diagnosis of acute, incomplete Bell's palsy, up to one month from onset of paralysis.
What does the study involve?
The control condition will receive usual physical therapy, consisting of neuromuscular reeducation and massage therapy. The experimental group will receive selective electrical muscle stimulation, in addition to usual physical therapy. For both groups, treatments are received once daily, Monday through Friday, until they are judged by their treating therapist to be fully recovered. At enrollment, discharge, and a follow-up visit 6 months after discharge, all participants will be video recorded performing 11 facial expressions. The video-recorded facial movements will be rated by two independent blinded reviewers using the House Brackmann scale and the eFACE scale.
What are the possible benefits and risks of participating?
All participants receive usual physical therapy, which is the standard of care for Bell's palsy. Half of the participants will receive electrical stimulation, which may decrease time to recovery from paralysis. Electrical stimulation may be associated with increased risk or severity of synkinesis.
Where is the study run from?
Universidad Nacionale del Nordeste, Corrientes, Argentina.
When is the study starting and how long is it expected to run for?
February 2017 to December 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Myriam Loyo, loyo@ohsu.edu
Contact information
Principal Investigator
Pérez de Herrera 2062
B° Cerro de las rosas
Cordoba
X5009 HWD
Argentina
| Phone | +54 351 482-5779 |
|---|---|
| tonydipi1@gmail.com |
Scientific
Pérez de Herrera 2062
B° Cerro de las rosas
Cordoba
X5009 HWD
Argentina
 ORCID ID |
0000-0001-6742-8640 |
|---|---|
| vilma.campana@unc.edu.ar |
Study information
| Study design | Alternate allocation controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Alternate allocation controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Efficacy of adding selective electrical muscle stimulation to usual physical therapy for Bell's palsy |
| Study hypothesis | Transcutaneously applied selective electrical muscle stimulation, delivered with physical therapy, will accelerate recovery from Bell's palsy, compared to physical therapy alone. |
| Ethics approval(s) | Approved 14/11/2013, Comité de bioética en investigación de ciencias de la salud – Facultad de medicina – Universidad Nacional del Nordeste (UNNE), (Moreno 1240, ciudad de Corrientes, Provincia de Corrientes, República Argentina; +54 9 379 4-436057; cbi@med.unne.edu.ar), ref: 30/17 |
| Condition | Bell's palsy |
| Intervention | Participants are assigned to groups using sequential allocation. The control condition will receive usual physical therapy, consisting of neuromuscular reeducation and massage therapy. The experimental group will receive selective electrical muscle stimulation, in addition to usual physical therapy. For both groups, treatments are received once daily, Monday through Friday, until they are judged by their treating therapist to be fully recovered. At enrollment, discharge, and a follow-up visit 6 months after discharge, all participants will be video recorded performing 11 facial expressions. The video-recorded facial movements will be rated by two independent blinded reviewers using the House Brackmann scale and the eFACE scale. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Electrical stimulation |
| Primary outcome measure | Static, dynamic, and synkinesis facial function were measured using the eFACE scale at baseline, completion of intervention, and 6 months after completion of intervention. |
| Secondary outcome measures | Facial function measured on the House Brackmann scale at baseline, completion of intervention, and 6 months after completion of intervention. |
| Overall study start date | 01/02/2017 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Diagnosis of acute, incomplete Bell's palsy, up to one month from onset of paralysis 2. Aged 18 years and above |
| Participant exclusion criteria | 1. Other causes of facial paralysis. 2. Hypertension 3. Diabetes 4. Prior facial physical therapy or muscle stimulation 5. Complete facial paralysis |
| Recruitment start date | 01/02/2017 |
| Recruitment end date | 01/06/2018 |
Locations
Countries of recruitment
- Argentina
Study participating centre
Corrientes
W3400 BCH
Argentina
Sponsor information
University/education
Moreno 1240, ciudad de Corrientes, Provincia de Corrientes, República Argentina.
Corrientes
W3400ACY
Argentina
| Phone | +54 9 379 4-436057 |
|---|---|
| webmaster@unne.edu.ar | |
| Website | www.med.unne.edu.ar |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from tonydipi1@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | in Spanish | 01/03/2023 | No | No | |
| Statistical Analysis Plan | 01/03/2023 | No | No | ||
| Dataset | 03/07/2023 | No | No | ||
| Results article | 24/10/2023 | 08/07/2024 | Yes | No |
Additional files
Editorial Notes
08/07/2024: Publication reference added.
03/07/2023: Internal review.
01/03/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
28/02/2023: A dataset was uploaded as an additional file.
27/02/2023: Trial's existence confirmed by Comité de bioética en investigación de ciencias de la salud – Facultad de medicina – Universidad Nacional del Nordeste (UNNE).
