Bell's palsy: Early aciclovir and/or prednisolone in Scotland

ISRCTN	ISRCTN71548196
DOI	https://doi.org/10.1186/ISRCTN71548196
Protocol serial number	HTA 02/09/04, 2002PS27
Sponsor	University of Dundee (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 10/08/2004
Registration date: 16/08/2004
Last edited: 27/10/2009

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 of protocol

Not provided at time of registration

Contact information

Prof Frank Sullivan
Scientific

Tayside Centre for General Practice
University of Dundee
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom

Phone	+44 (0)1382 420022
Email	f.m.sullivan@dundee.ac.uk

Study information

Primary study design	Interventional
Study design	2 x 2 randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	BELLS
Study objectives	1. To describe the resolution of neurological deficit and cosmetic, psychological and functional recovery in each of four groups of patients: those treated with prednisolone, aciclovir, both, or neither. 2. To determine which group of patients have the greatest reduction in neurological disability scores on the House and Brackmann grading system at 3 and 9 months after randomisation. 3. To compare self-reported health status (including assessments of pain) at 3 and 9 months after randomisation. 4. To compare the incremental cost per neurological deficit resolved and incremental cost per QALY in the study groups
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Bell's Palsy
Intervention	Design is 2x2 Randomised Controlled Trial (RCT), the 4 arms being: 1. Prednisolone and placebo 2. Aciclovir and placebo 3. Prednisolone and aciclovir 4. Placebo and placebo Dosage as follows: prednisolone 50 mg/day x 10 days, aciclovir 2000 mg/day x 10 days, lactose placebo indistinguishable.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	prednisolone, aciclovir
Primary outcome measure(s)	1. House-Brackmann grading system for facial nerve function 2. Health Utilities Index 3. Chronic pain grade 4. Costs
Key secondary outcome measure(s)	1. Brief Pain Inventory 2. Derriford Appearance Questionnaire (DAS59)
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	720
Key inclusion criteria	Adults (16 or older) diagnosed with Bell's Palsy and with no excluding conditions and who can be consented at participating centres in Scotland within 72 hours of onset.
Key exclusion criteria	1. Pregnancy 2. Uncontrolled diabetes (HbA1c >8%) 3. Peptic ulcer disease 4. Suppurative otitis media 5. Herpes zoster 6. Multiple sclerosis 7. Sarcoidosis and other rarer conditions 8. Inability to give informed consent 9. Breast-feeding 10. Patients with systemic infection
Date of first enrolment	01/11/2003
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Tayside Centre for General Practice

Dundee
DD2 4BF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/10/2007		Yes	No
Results article	results	01/10/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes