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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether gargling with warm salt water (sodium chloride gargle) can ease swallowing difficulties after neck surgery known as ACDF. Participants will either gargle with salt water or not, and both groups will complete questionnaires about their symptoms. The trial aims to determine if the saltwater gargle can facilitate easier swallowing during recovery. Candidates who have recently undergone ACDF surgery at Keck Medical Center and are experiencing swallowing difficulties may be suitable for participation. As an unphased trial, this study offers participants the opportunity to contribute to research that could enhance recovery experiences for future patients.

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.

What prior data suggests that this saltwater gargle is safe for reducing swallowing difficulty?

Research shows that gargling with saltwater is generally safe and easy. Studies have found it to be an effective and simple way to relieve sore throat symptoms, reducing pain and other symptoms without causing harm. This low-cost method carries very few risks, making it safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the salt water gargling trial for swallowing difficulty because it offers a simple and natural approach compared to standard treatments, which often involve medication or surgery. This method uses a sodium chloride solution, tapping into the anti-inflammatory and soothing properties of salt water, which is a familiar and accessible ingredient. Unlike other treatments that may require more complex interventions, salt water gargling is non-invasive and can be easily administered at home. This trial could reveal a cost-effective and straightforward option for improving postoperative recovery in patients facing swallowing challenges.

What evidence suggests that salt water gargling is effective for swallowing difficulty?

Studies have shown that gargling with salt water can ease sore throat symptoms and make swallowing easier by reducing swelling and pain in the throat. Research indicates that people who gargle with salt water feel relief within minutes. In one study, participants reported less throat soreness and found it easier to swallow after using a salt solution. In this trial, one group will receive the salt water gargle treatment to assess its effectiveness for swallowing difficulties after surgeries like multi-level anterior cervical discectomy and fusion (ACDF). These findings suggest that salt water gargling might also help with swallowing difficulties following such surgeries. ^{1 4 5 6 7}

Who Is on the Research Team?

Ram K Alluri, M.D.

Principal Investigator

Assistant Professor of Clinical Orthopaedic Surgery

Are You a Good Fit for This Trial?

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.

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06475365

Salt Water Gargling on Swallowing Following ACDF The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" ...

2. withpower.com withpower.com/trial/salt-water-gargling-for-swallowing-difficulty-97326

Salt Water Gargling for Swallowing Difficulty Trial Overview The study tests if gargling with warm salt water can reduce swallowing difficulties after ACDF surgery. Participants will be randomly assigned ...

3. researchgate.net researchgate.net/publication/335681220_Randomised_Controlled_Trial_of_Salt_Solution_Sodium_Chloride_Mouth_Wash_vs_Thymol_Glycerine_Usage_in_Sore_Throat_with_Non_Bacterial_Pharyngitis

Randomised Controlled Trial of Salt Solution (Sodium ... Sore throat relief, improvements in throat soreness and difficulty in swallowing, and throat numbness were observed as early as 1-5 minutes, and ...

4. consensus.app consensus.app/questions/salt-water-gargle-effectiveness-for-sore-throat/

Salt Water Gargle Effectiveness For Sore Throat Gargling with salt water, or saline solution, has been shown to be an effective and simple method for alleviating sore throat symptoms in various contexts.

5. journaljocamr.com journaljocamr.com/index.php/JOCAMR/article/view/156

Randomised Controlled Trial of Salt Solution (Sodium ... Gargling a salt solution, a natural, and harmless substance, can reduce the pain and other symptom of sore throat in patients with non-bacterial pharyngitis.

6. consensus.app consensus.app/questions/salt-water-gargle-efficacy-for-sore-throat/

Salt Water Gargle Efficacy For Sore Throat Gargling with salt water, or saline solution, has been shown to be an effective and simple method for alleviating sore throat symptoms in various contexts.

7. droracle.ai droracle.ai/articles/141987/what-are-the-benefits-of-saline-gargles-sodium-chloride

What are the benefits of saline gargles (sodium chloride ... Saline gargles are a low-cost intervention with minimal potential harm and may be beneficial in reducing upper respiratory tract infections, ...