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

June 30, 2014 updated by: Malou Hultcrantz, Karolinska Institutet

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-751 85
        • Uppsala Akademiska Hospital, EENT department
    • Solna
      • Stockholm, Solna, Sweden, SE-17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early surgery
Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method
Procedure: Baby-sitter surgery N. fascialis
Active Comparator: Conventional treatment and follow-up
Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model.
Other: Conventional treatment and follow-up
Patient´s with Bells´palasy are treated with conventional treatment and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial Disability Index
Time Frame: 15 month
Change in Facial Disability Index
15 month
FaCe
Time Frame: 15 month
Change in FaCe quality score
15 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Malou Hultcrantz, M.D prof., Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

June 30, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bell´sPalsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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