Back to resultsSurgery or Clincial Follow up, in Patients With Bell' s Palsy
Primary Purpose
Bell Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Baby-sitter surgery N. fascialis
Conventional treatment and follow-up
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy focused on measuring Cranial Nerve fascial paresis
Eligibility Criteria
Inclusion Criteria:
- Patients with Bell´s Palsy
- Men and women aged 18-55 y
- Score < 70 according to Sunny Brook scale (SB)
- Signed informed consent
Exclusion Criteria:
- High bloodpressure
- Diabetes
- Pregnancy
- Currently on immunodepressive treatment
- Smoker
- Psychiatric disorder
- Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery
Sites / Locations
- Karolinska University Hospital
- Uppsala Akademiska Hospital, EENT department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early surgery
Conventional treatment and follow-up
Arm Description
Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method
Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Facial Disability Index
Change in Facial Disability Index
FaCe
Change in FaCe quality score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02179684
Brief Title
Surgery or Clincial Follow up, in Patients With Bell' s Palsy
Official Title
Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Cranial Nerve fascial paresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early surgery
Arm Type
Experimental
Arm Description
Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method
Arm Title
Conventional treatment and follow-up
Arm Type
Active Comparator
Arm Description
Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
Intervention Type
Procedure
Intervention Name(s)
Baby-sitter surgery N. fascialis
Intervention Type
Other
Intervention Name(s)
Conventional treatment and follow-up
Intervention Description
Patient´s with Bells´palasy are treated with conventional treatment and follow-up
Primary Outcome Measure Information:
Title
Sunny Brook (SB) score > 70
Description
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 Outcome Measure Information:
Title
Facial Disability Index
Description
Change in Facial Disability Index
Time Frame
15 month
Title
FaCe
Description
Change in FaCe quality score
Time Frame
15 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Bell´s Palsy
Men and women aged 18-55 y
Score < 70 according to Sunny Brook scale (SB)
Signed informed consent
Exclusion Criteria:
High bloodpressure
Diabetes
Pregnancy
Currently on immunodepressive treatment
Smoker
Psychiatric disorder
Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malou Hultcrantz, M.D prof.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
State/Province
Solna
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
Uppsala Akademiska Hospital, EENT department
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Surgery or Clincial Follow up, in Patients With Bell' s Palsy
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