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Salt Water Gargling for Swallowing Difficulty

N/A

Waitlist Available

Led By Ram K Alluri, M.D.

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Patients undergoing a multi-level (2-, 3-, or 4-level) ACDF procedure

Must not have

Patients must be ≤ 18 years of age

Patients with spinal pathologies or deformities that are non-degenerative or idiopathic (i.e. trauma, infection, malignancy, or tumor)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 - 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if gargling with warm salt water can help reduce swallowing difficulties after neck surgery. Healthy adults aged 18-80 will be part of the study. Participants will either gargle

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Gargling with warm salt water is a low-risk intervention; however, some may experience mild throat irritation or discomfort from the practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I am having a single-approach ACDF surgery and I speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am 18 years old or younger.

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

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I am having a revision surgery for my cervical spine.

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I am having surgery on my neck from both the front and back.

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My health is severely limited by my illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 - 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 - 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with a SWAL-QOL Score of Greater Than 14

Secondary study objectives

Neck Disability Index (NDI) Score of 30 to 100

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Salt Water GargleExperimental Treatment1 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: ControlActive Control1 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.

0 / 8Eligibility criteria met