Salt Water Gargling on Swallowing Following ACDF

University of Southern California

Status: Invitation-only

Conditions: Dysphagia; Cervical Spondylosis; Cervical Myelopathy; Cervical Radiculopathy; Degeneration Spine; Cervical Stenosis

Treatments: Other: Sodium chloride gargle

Study type: Interventional

Funder types: Other

Identifiers

NCT06475365

HS-24-00348

Details and patient eligibility

About

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.

Full description

Background & Hypothesis:

Dysphagia, or difficulty swallowing, often signifies structural or functional abnormalities in any of the three phases of swallowing and contributes to higher self-reported disability and lower physical health status. Dysphagia is a common postoperative complication following anterior cervical discectomy and fusion (ACDF) procedures. While most experience mild and transient symptoms, some individuals endure severe dysphagia, leading to significant postoperative morbidity.

Several studies have demonstrated the efficacy of corticosteroids administered intraoperatively during ACDF procedures. One prospective, randomized, double-blinded study, showed favorable results with local corticosteroid administration, resulting in a significant decrease in dysphagia during the immediate postoperative period to 1-month postoperatively. Although other studies have also reported favorable outcomes with corticosteroid use, they are still associated with considerable risks of adverse events. Corticosteroids have been linked to a higher incidence of postoperative infection, impairment of wound healing, and a 2- to 5-fold increase in wound complications across a variety of surgical specialties.

Salt water, also known as saline is associated with anti-inflammatory, anti-bacterial, and wound healing properties. Warm salt water rinses offer a more accessible, cost-effective alternative to corticosteroids, without their associated adverse effects. The study aims to investigate the efficacy of gargling salt water in reducing the severity and symptoms of swallowing difficulties following multi-level ACDF procedures.

This study is a single-center, prospective, randomized control trial. Only patients ≥ 18 years of age who are undergoing a multi-level (2-, 3-, or 4-level ACDF) and meet the general inclusion criterion will be invited to participate in the study.

Methodology:

1. Patients will be screened using the general inclusion/exclusion parameters
2. Patients will be randomized into one of two groups: control or experimental using a 1:1 ratio
3. Patients will complete three (3) questionnaires at selected time points throughout the study duration
4. Patients in the experimental arm will be asked to gargle with a saltwater solution one (1) time on POD 0 and three (3) times per day with approximately 15 milliliters (mL) per mouthful for seven (7) days (POD 1 - POD 7) + scheduled questionnaires
5. Patients in the control arm will only be asked to complete the scheduled questionnaires

Required questionnaires:

1. Swallow Quality of Life Questionnaire (SWAL-QOL)
2. Visual Analogue Scale - Neck (VAS Neck)
3. Eating Assessment Tool (EAT-10)

General study execution:

Patients in the interventional arm will be provided with a premade sodium chloride (sterile saltwater solution), 8-ounce-marked measuring cups, and a detailed instruction sheet with the relevant contacts for the study.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Salt Water Gargle

Experimental group

Description:

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.

Treatment:

Other: Sodium chloride gargle