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

Not Applicable

• Conditions: Bell Palsy
• Interventions: Other: Conventional treatment and follow-up; Procedure: Baby-sitter surgery N. fascialis

• Registration Number: NCT02179684
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-06-30
• Last Update Submitted: 2014-06-30
• Study First Posted: 2014-07-02
• Last Update Posted: 2014-07-02
• Primary Completion: 2018-02
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment and follow-up	Conventional treatment and follow-up	Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
Early surgery	Baby-sitter surgery N. fascialis	Patienst with Bell´s Palsy with an early surgical intervention (\< 3month), according to 'baby-sitter' method

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Facial Disability Index	15 month	Change in Facial Disability Index
FaCe	15 month	Change in FaCe quality score

Trial Locations

Locations (2)

Uppsala Akademiska Hospital, EENT department; 🇸🇪 Uppsala, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Solna, Sweden