Salt Water Gargling for Swallowing Difficulty

Overseen By Raymond J Hah, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Revision ACDF, Combined approaches, Non-degenerative pathologies, Prior swallowing issues, ASA score ≥ 4

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is salt water gargling safe for humans?

Research suggests that using salt water for gargling is generally safe for humans, as it is a common practice for soothing throat discomfort. However, high concentrations of salt can irritate the throat, so it's important to use a mild solution. ^{1 2 3 4 5}

How does salt water gargling differ from other treatments for swallowing difficulty?

Salt water gargling is unique because it involves using a simple saline solution to stimulate the throat, which can help trigger the swallowing reflex. Unlike other treatments that may involve medication or more complex procedures, this method uses the natural properties of salt and water to facilitate swallowing. ^{2 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Ram K Alluri, M.D.

Principal Investigator

Assistant Professor of Clinical Orthopaedic Surgery

Eligibility Criteria

This trial is for generally healthy adults aged 18-80 who have undergone multi-level anterior cervical discectomy and fusion (ACDF) surgery. It's designed to help those experiencing difficulty swallowing post-surgery. Specific conditions like cervical radiculopathy, stenosis, spondylosis, myelopathy, and related spinal issues are included.

Inclusion Criteria

Patients undergoing treatment at Keck Medical Center of USC

I am having a surgery to fuse two or more neck vertebrae.

Exclusion Criteria

My health is severely limited by my illness.

My spine condition is not due to aging or unknown causes but from specific events like injury or disease.

I am having a revision surgery for my cervical spine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants in the experimental arm gargle with a warm saltwater solution once on POD 0, and three times daily from POD 1 to POD 7. Both arms complete questionnaires at specified intervals.

1 week

Daily self-administered treatment and questionnaire completion

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires completed at 1-month postoperatively.

3 weeks

1 visit (in-person) at 1 month

Treatment Details

Interventions

• Sodium chloride gargle

Trial Overview The study tests if gargling with warm salt water can reduce swallowing difficulties after ACDF surgery. Participants will be randomly assigned to either the control group or the experimental group that gargles saltwater in addition to completing questionnaires on their condition.

Participant Groups

Group I: Salt Water Gargle Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Alkaline ingestions. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effect of stimulation of the laryngopharynx with water and salt solutions on voluntary swallowing in humans: characteristics of water receptors in the laryngopharyngeal mucosa. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Upper Gastrointestinal Endoscopic Evaluation Following Household Sodium Hypochlorite Ingestion. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Cytoprotective effect of sulfate ions in acid-exposed rabbit esophagus. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Flavored Lubricating Oral Spray on Medication Swallowing in Older Individuals. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

Reflex swallowing elicited by water and chemical substances applied in the oral cavity, pharynx, and larynx of the rabbit. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The influence of chemical gustatory stimuli and oral anaesthesia on healthy human pharyngeal swallowing. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Respiratory suppression and swallowing from introduction of fluids into the laryngeal region of the lamb. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The use of Coca-Cola in the management of bolus obstruction in benign oesophageal stricture. [2022]