Bell's palsy: Early aciclovir and/or prednisolone in Scotland
| ISRCTN | ISRCTN71548196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71548196 |
| Secondary identifying numbers | HTA 02/09/04, 2002PS27 |
- 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
Not provided at time of registration
Contact information
Prof Frank Sullivan
Scientific
Scientific
Tayside Centre for General Practice
University of Dundee
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom
| Phone | +44 (0)1382 420022 |
|---|---|
| f.m.sullivan@dundee.ac.uk |
Study information
| Study design | 2 x 2 randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.dundee.ac.uk/bells/sbps_files/sbps_pis_a4_nul.rtf |
| Scientific title | |
| Study acronym | BELLS |
| 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(s) | Not provided at time of registration. |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | prednisolone, aciclovir |
| Primary outcome measure | 1. House-Brackmann grading system for facial nerve function 2. Health Utilities Index 3. Chronic pain grade 4. Costs |
| Secondary outcome measures | 1. Brief Pain Inventory 2. Derriford Appearance Questionnaire (DAS59) |
| Overall study start date | 01/11/2003 |
| Overall study end date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 720 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/11/2003 |
| Recruitment end date | 30/06/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Tayside Centre for General Practice
Dundee
DD2 4BF
United Kingdom
DD2 4BF
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Nethergate
Dundee
DD1 4HN
Scotland
United Kingdom
| Phone | +44 (0)1382 344000 |
|---|---|
| university@dundee.ac.uk | |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
