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.
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJuly 2, 2014
June 1, 2014
4.3 years
June 30, 2014
June 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (2)
Facial Disability Index
15 month
FaCe
15 month
Study Arms (2)
Early surgery
EXPERIMENTALPatienst with Bell´s Palsy with an early surgical intervention (\< 3month), according to 'baby-sitter' method
Conventional treatment and follow-up
ACTIVE COMPARATORPatienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
Interventions
Patient´s with Bells´palasy are treated with conventional treatment and follow-up
Eligibility Criteria
You may qualify if:
- Patients with Bell´s Palsy
- Men and women aged 18-55 y
- Score \< 70 according to Sunny Brook scale (SB)
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Karolinska University Hospital
Stockholm, Solna, SE-17176, Sweden
Uppsala Akademiska Hospital, EENT department
Uppsala, Uppsala County, SE-751 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malou Hultcrantz, M.D prof.
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Professor
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 2, 2014
Study Start
November 1, 2013
Primary Completion
February 1, 2018
Study Completion
November 1, 2019
Last Updated
July 2, 2014
Record last verified: 2014-06