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

Karolinska Institute

Status: Unknown

Conditions: Bell Palsy

Treatments: Other: Conventional treatment and follow-up; Procedure: Baby-sitter surgery N. fascialis

Study type: Interventional

Funder types: Other

Identifiers

NCT02179684

Bell´sPalsy

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Early surgery

Experimental group

Description:

Patienst with Bell´s Palsy with an early surgical intervention (\< 3month), according to 'baby-sitter' method

Treatment:

Procedure: Baby-sitter surgery N. fascialis

Conventional treatment and follow-up

Active Comparator group

Description:

Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.

Treatment:

Other: Conventional treatment and follow-up