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Salt Water Gargling on Swallowing Following ACDF

NCT06475365 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-18

No results posted yet for this study

Summary

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

Interventions

OTHER

Sodium chloride gargle

15mL salt water gargle

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Ram K Alluri, M.D. · Assistant Professor of Clinical Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475365 on ClinicalTrials.gov