|
ISRCTN
|
ISRCTN71548196
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Bell's palsy: Early aciclovir and/or prednisolone in Scotland
|
|
Scientific title
|
|
|
Acronym
|
BELLS
|
|
Serial number at source
|
HTA 02/09/2004, 2002PS27
|
|
Study hypothesis
|
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
|
Not provided at time of registration.
|
|
Study design
|
2 x 2 randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Bell's Palsy
|
|
Participants - 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.
|
|
Participants - 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
|
|
Anticipated start date
|
01/11/2003
|
|
Anticipated end date
|
30/06/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
Patient information can be found at: http://www.dundee.ac.uk/bells/sbps_files/sbps_pis_a4_nul.rtf
|
|
Target number of participants
|
720
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
1. House-Brackmann grading system for facial nerve function
2. Health Utilities Index
3. Chronic pain grade
4. Costs
|
|
Secondary outcome measure(s)
|
1. Brief Pain Inventory
2. Derriford Appearance Questionnaire (DAS59)
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
http://www.dundee.ac.uk/bells/
|
|
Publications
|
Results: http://www.ncbi.nlm.nih.gov/pubmed/17942873
|
|
Contact name
|
Prof
Frank
Sullivan
|
|
Address
|
Tayside Centre for General Practice
University of Dundee
Kirsty Semple Way
|
|
City/town
|
Dundee
|
|
Zip/Postcode
|
DD2 4BF
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1382 420022
|
|
Fax
|
+44 (0)1382 420010
|
|
Email
|
f.m.sullivan@dundee.ac.uk
|
|
Sponsor
|
University of Dundee (UK)
|
|
Address
|
Nethergate
|
|
City/town
|
Dundee
|
|
Zip/Postcode
|
DD1 4HN
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1382 344000
|
|
Fax
|
+44 (0)1382 201604
|
|
Email
|
university@dundee.ac.uk
|
|
Date applied
|
10/08/2004
|
|
Last edited
|
08/05/2008
|
|
Date ISRCTN assigned
|
16/08/2004
|
