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NCT02179684 Clinical Trial

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

Bell Palsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02179684
Other study ID # Bell´sPalsy
Secondary ID
Status Enrolling by invitation
Phase N/A
First received June 30, 2014
Last updated June 30, 2014
Start date November 2013
Est. completion date November 2019

Study information
Verified date June 2014
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 150
Est. completion date November 2019
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Baby-sitter surgery N. fascialis

Other:
• Conventional treatment and follow-up
Patient´s with Bells´palasy are treated with conventional treatment and follow-up

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm Solna
Sweden Uppsala Akademiska Hospital, EENT department Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Facial Disability Index Change in Facial Disability Index 15 month No
Secondary FaCe Change in FaCe quality score 15 month No
See also
  Status Clinical Trial Phase
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Terminated NCT03996525 - Electrical Stimulation to Improve Recovery After Peripheral Nerve Injury N/A
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Completed NCT04807491 - Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy N/A
Completed NCT03592797 - Effect of Laser Acupuncture Treatment on Chronic Facial Paralysis N/A
Recruiting NCT03781700 - Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy Phase 4
Recruiting NCT04406376 - Do We Need to Taper Down Steroid Therapy for Bell's Palsy Phase 4
Recruiting NCT06029855 - Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy N/A
Recruiting NCT06340009 - MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy N/A
Completed NCT04280120 - Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial N/A
Completed NCT05891106 - AONDA Therapeutic Indication Study I
Completed NCT03974763 - Function and Form Outcomes in Patients With Facial Paralysis
Active, not recruiting NCT05997199 - The Effect Vitamin D on the Recovery Rate of Bell Palsy
Completed NCT04412733 - EFFECTİVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENTS WITH BELL'S PALSY N/A
Recruiting NCT06028191 - Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy N/A
Recruiting NCT05582915 - Screening for Prognostic Biomarkers of Severe Bell's Palsy in Adults
Terminated NCT03836989 - Electrical Stimulation to Promote Recovery in Bells Palsy N/A
Recruiting NCT05270187 - Multiwave Locked System Laser for Patients With Bell's Palsy. N/A
Recruiting NCT06308250 - Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy N/A
Not yet recruiting NCT06213415 - Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy N/A