S  B  P  S

 

Scottish Bell's Palsy Study

Welcome

How to Refer a Patient

What is Bell’s Palsy?

What is the S B P S?

Who’s Who

The Trial Sites

The Patient’s Experience

Graeme’s Story

House-Brackmann Scale

The Questionnaires

Documentation

Legal Stuff

Links to other web sites

What is the S B P S?

The Scottish Bell’s Palsy Study is a coordinated national randomised clinical trial including patients and clinics throughout Scotland, and having two main aims, being

•     to describe the resolution of neurological deficit and cosmetic, psychological and functional recovery in each of four groups of patients: those treated with prednisolone, with acyclovir, both, or neither

•     to determine which group of patients have the greatest reduction in neurological disability scores on the House-Brackmann grading system at three and nine months after commencement of treatment

The study will also collect and analyse the results from questionnaires giving self-reported assessment of symptoms and pain, and will also include a cost analysis for the different treatment groups.

It is required that a minimum of 480 patients will be recruited into the study and allocated to treatment groups as follows:

The facial nerve

Aims and Objectives

The allocation to group is made at random by computer when the patient is referred to a participating clinic and elects to join the study. The medications are disguised and neither the patient nor the doctor will know what the allocated treatment contains.

Methods

Patients exhibiting symptoms suggestive of Bell’s Palsy will be referred by participating GPs, NHS24 and A and E clinics (depending where the patient first present themselves) to participating specialist acute receiving clinics in ENT departments in hospitals throughout Scotland (see The Sites). There, if a diagnosis is confirmed and if the patient satisfies all the criteria for entry, and is willing to join the study, they are immediately consented into it and the decision is made by a random process which of the four treatments to allocate. Treatment commences immediately and lasts 10 days, the doses being

 

 

or placebo (lactose indistinguishable) in each case. Assessments take place at baseline (i.e. as soon as possible after the commencement of treatment), after three months and after nine months, and include the recording of photographic images of the patient’s face adopting fixed poses, and questionnaire responses: these are

•     HUI (Health Utilities Index) Mark 3

· DAS (Derriford Appearance Scale) 59

· Brief Pain Inventory

It is intended to assess up to 720 patients for eligibility for recruitment into the study with the aim of recruiting two-thirds of these (480 patients) who should all commence treatment within 72 hours of onset.