Surgery or Clincial Follow up, in Patients With Bell' s Palsy

Karolinska Institutet150 enrolled

Overview

The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Bell Palsy

Interventions

Baby-sitter surgery N. fascialisPROCEDURE

Conventional treatment and follow-upOTHER

Patient´s with Bells´palasy are treated with conventional treatment and follow-up

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with Bell´s Palsy 2. Men and women aged 18-55 y 3. Score \< 70 according to Sunny Brook scale (SB) 4. Signed informed consent Exclusion Criteria: 1. High bloodpressure 2. Diabetes 3. Pregnancy 4. Currently on immunodepressive treatment 5. Smoker 6. Psychiatric disorder 7. Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery

Locations (2)

Karolinska University Hospital

Stockholm, Solna, Sweden

Uppsala Akademiska Hospital, EENT department

Uppsala, Uppsala County, Sweden

Outcomes

Primary Outcomes

Sunny Brook (SB) score > 70

Patients with Bell´s Palsy that has been randomized to conventional treatment or early surgical intervention are scored according to SB after 12 month of study participation.

Time frame: 1 year

Secondary Outcomes

Facial Disability Index

Change in Facial Disability Index

Time frame: 15 month

FaCe

Change in FaCe quality score

Time frame: 15 month

Data from ClinicalTrials.gov

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