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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:
Sponsor: Karolinska Institutet

Current Primary Outcome: Sunny Brook (SB) score > 70 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Facial Disability Index [ Time Frame: 15 month ]
    Change in Facial Disability Index
  • FaCe [ Time Frame: 15 month ]
    Change in FaCe quality score


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: June 30, 2014
Date Started: November 2013
Date Completion: November 2019
Last Updated: June 30, 2014
Last Verified: June 2014