Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02163772|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Paralysis, Unilateral, Vocal Cord||Procedure: Intracordal hyaluronate injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2013|
Experimental: Intracordal hyaluronate injection (HI)
The intervention of Intracordal hyaluronate (Restylane) injection is given in this group No other therapies are given
Procedure: Intracordal hyaluronate injection
Other Name: Resylane
No Intervention: Conservative management (CM)
In this arm, only observation is arranged. No therapy is given.
- voice outcome [ Time Frame: before intervention and at 6 month follow-up ]VOS score: The VOS originally developed by Gliklich et al. comprises a five-item survey that evaluates the physical and social problems associated with unilateral vocal fold palsy.
- laryngeal electromyography [ Time Frame: before and 6 months post intervention ]laryngeal electromyography signals were obtained using a concentric needle electrode with the surface-ground electrode adhered to the forehead. We examined the electromyography signals on bilateral thyroarytenoid muscle and cricothyroid muscles. With the concentric needle electrode in the thyroarytenoid muscle , the patient was asked to produce three series of "e"s at three different intensities (low, moderate and highest possible), with each "e" lasting at least 400 ms and each inter-"e" interval lasting about 200 ms. To evaluate cricothyroid function, the patients were asked to produce a glissando upward "e" at normal loudness.
- videolaryngostroboscopy [ Time Frame: before and 6 months post intervention ]An image of glottis was captured during the videolaryngoscopy examination while the patient vocalized /eee/ at modal pitch and regular loudness. The images showing the narrowest vocal slitglottal gap from several phonatory cycles were measured.
- laboratory voice analysis [ Time Frame: before and 6 months post intervention ]In a sound-insulated room, the patient read a standard passage and a sustained vowel at a conversational pitch and loudness. The patient's voice was captured using a unidirectional dynamic microphone (Shure SM48; Shure Brothers Inc., Agua Prieta, Mexico).
- health related quality of life (SF-36) [ Time Frame: before and 6 months post intervention ]The SF-36 questionnaire is designed for general health measurement of 8 domains, including physical functioning, role functioning-physical problems, bodily pain, general health, vitality, social functioning, role functioning-emotional problems, and mental health. The recall period of SF-36 is 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163772
|Chang Gung Memorial Hospital|
|Taoyuan County, Taiwan|