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

Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02179684

Enrollment

150

Registered

2014-07-02

Start date

2013-11-30

Completion date

2019-11-30

Last updated

2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bell Palsy

Keywords

Cranial Nerve fascial paresis

Brief summary

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.

Interventions

PROCEDUREBaby-sitter surgery N. fascialis

OTHERConventional treatment and follow-up

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sunny Brook (SB) score > 70	1 year	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.

Secondary

Measure	Time frame	Description
Facial Disability Index	15 month	Change in Facial Disability Index
FaCe	15 month	Change in FaCe quality score

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026