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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bell Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early surgery

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

Group Type EXPERIMENTAL

Baby-sitter surgery N. fascialis

Intervention Type PROCEDURE

Conventional treatment and follow-up

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

Group Type ACTIVE_COMPARATOR

Conventional treatment and follow-up

Intervention Type OTHER

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

Interventions

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Baby-sitter surgery N. fascialis

Intervention Type PROCEDURE

Conventional treatment and follow-up

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No