Salt Water Gargling on Swallowing Following ACDF

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06475365
Status
Enrolling By Invitation

Conditions

  • Cervical Myelopathy
  • Cervical Radiculopathy
  • Cervical Spondylosis
  • Cervical Stenosis
  • Degeneration Spine
  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Sodium chloride gargle — OTHER
    15mL salt water gargle

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Mar 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Control
    This arm will receive no intervention. The patients in this arm will only be asked to complete the questionnaires related to the study. They will only receive the care as prescribed by their physician and care teams.
  • Experimental: Salt Water Gargle
    After their surgery, this arm will receive "treatment." Patients will be asked to gargle with a warm sodium chloride (salt water) solution. Patients will gargle with 15mL (15cc) of a premade solution of salt water one time (q.d.) on postoperative day 0 (POD 0), and three times a day (t.i.d.) for the next seven (7) days following their surgery (POD 1 - POD 7). Patients will also be asked to complete a series of study-related questionnaires at specified time points.

Primary Outcome Measure

Number of Participants with a SWAL-QOL Score of Greater Than 14 [ Time Frame: 0 - 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
Keck Medical Center of the University of Southern CaliforniaLos AngelesCalifornia90089-

Find similar trials in Los Angeles, CA

By research site
Keck Medical Center of the University of Southern California· Los Angeles, CA

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