NOT_YET_RECRUITING
Salt Water Gargling on Swallowing Following ACDF
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is: If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water. Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery. Patients in the control arm will be asked to: - Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively). Patients in the experimental/interventional arm will be asked to: * Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively). * Gargle with a warm saltwater solution once on POD 0, and thrice daily from POD 1 to POD 7.
Conditions:
🦠 Degeneration Spine 🦠 Cervical Radiculopathy 🦠 Cervical Stenosis 🦠 Cervical Spondylosis 🦠 Cervical Myelopathy 🦠 Dysphagia
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 30 September 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients ≥ 18 years of age
    • * Patients undergoing a multi-level (2-, 3-, or 4-level) ACDF procedure
    • * Single-approach (anterior only) ACDF - English or Spanish-speaking patients
    • * Undergoing treatment at Keck Medical Center of USC

    Exclusion Criteria:

    • * Patients ≤ 18 years of age
    • * Patients undergoing any revision ACDF procedure
    • * Patients undergoing ACDF with combined approaches (i.e. anterior + posterior)
    • * Patients with spinal pathologies or deformities that are non-degenerative or idiopathic (i.e. trauma, infection, malignancy, or tumor)
    • * Patients with a prior diagnosis related to swallowing issues (i.e. esophagitis, Barrett's esophagus, Sjogren syndrome, multiple sclerosis (MS), or laryngitis)
    • * Patients with an American Society of Anesthesiologists (ASA) score ≥ 4
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 13 June 2024
  • First Submitted that Met QC Criteria 24 June 2024
  • First Posted 26 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 June 2024
  • Last Update Posted 26 June 2024
  • Last Verified June 2024