Clinical trial NCT02163772: Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis
Official title: Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralysis, Unilateral, Vocal Cord
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-06-16
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN) injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes. Although the long term treatment effect is encouraged, the point when to perform surgical treatment is not conclusive. Previous reports suggested late treatment principle because patients may spontaneous reinnervation to some degree within 4-5 months after injury. The vocal cord position and tone may change during reinnervation. Others delineated laryngeal synkinesis by misdirected reinnervation is common and suggested early temporary injection laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short term voice outcomes but also decrease the incidence of transcervical laryngeal framework surgery as a determined surgery. However, lacking of prospective study and objective data makes the treatment-time policy still controversial. Purposes: 1. To find incidence of spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early intracordal hyaluronic acid injection on vocal cord position change in patients with laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study. Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and 12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data and quality of life will be compared. The outcomes will also be correlated with laryngeal electromyography (LEMG) data and the impact of synkinetic reinnervation.


Eligibility criteria: Inclusion Criteria:

* Patients of untreated unilateral vocal cord paralysis with a known cause of RLN injury within 3-6 month will be enrolled

Exclusion Criteria:

* Patients proved to be not suitable for transcutaneous intracordal injection under topical anesthesia. Those who had previous phonosurgery or can't follow the observation rule will also be excluded.

Primary outcomes:
measure: voice outcome
timeFrame: before intervention and at 6 month follow-up
Secondary outcomes:
measure: laryngeal electromyography
timeFrame: before and 6 months post intervention
measure: videolaryngostroboscopy
timeFrame: before and 6 months post intervention
measure: laboratory voice analysis
timeFrame: before and 6 months post intervention
measure: health related quality of life (SF-36)
timeFrame: before and 6 months post intervention
Other outcomes:
Locations:
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
citation: Pei YC, Fang TJ, Hsin LJ, Li HY, Wong AM. Early hyaluronate injection improves quality of life but not neural recovery in unilateral vocal fold paralysis: an open-label randomized controlled study. Restor Neurol Neurosci. 2015;33(2):121-30. doi: 10.3233/RNN-140439.