Salt Water Gargling on Swallowing Following ACDF

NCT06475365 | Enrolling By Invitation

• 1 other identifier: HS-24-00348
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ACDF; Anterior cervical discectomy & fusion; Cervical spine; Dysphagia

Outcome Measures

Primary Outcomes (1)

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

  The Swallowing-Related Quality of Life (SWAL-QOL) questionnaire is a 44-question assessment that measures the severity of oropharyngeal dysphagia (difficulty swallowing) and the impact it has on quality of life. Patients with score of greater than or equal to 14 are indicative of have some sort of difficulty with swallowing. This will be used to assess if patients in the Salt Water Gargle arm (intervention) have any relief after completing the described intervention.

  0 - 1 month

Secondary Outcomes (1)

• Neck Disability Index (NDI) Score of 30 to 100

  0 - 1 month

Study Arms (2)

Control

NO 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.

Salt Water Gargle

EXPERIMENTAL

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.

Other: Sodium chloride gargle

Interventions

Sodium chloride gargle OTHER

15mL salt water gargle

Also known as: Salt water gargle

Salt Water Gargle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medical Center of the University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (14)

• Adenikinju AS, Halani SH, Rindler RS, Gary MF, Michael KW, Ahmad FU. Effect of perioperative steroids on dysphagia after anterior cervical spine surgery: A systematic review. Int J Spine Surg. 2017 Mar 6;11(2):9. doi: 10.14444/4009. eCollection 2017.

  PMID: 28377867 BACKGROUND

• Anderson KK, Arnold PM. Oropharyngeal Dysphagia after anterior cervical spine surgery: a review. Global Spine J. 2013 Dec;3(4):273-86. doi: 10.1055/s-0033-1354253. Epub 2013 Aug 30.

  PMID: 24436882 BACKGROUND

• Campbell PG, Yadla S, Malone J, Zussman B, Maltenfort MG, Sharan AD, Harrop JS, Ratliff JK. Early complications related to approach in cervical spine surgery: single-center prospective study. World Neurosurg. 2010 Aug-Sep;74(2-3):363-8. doi: 10.1016/j.wneu.2010.05.034.

  PMID: 21492571 BACKGROUND

• Collins JR, Veras K, Hernandez M, Hou W, Hong H, Romanos GE. Anti-inflammatory effect of salt water and chlorhexidine 0.12% mouthrinse after periodontal surgery: a randomized prospective clinical study. Clin Oral Investig. 2021 Jul;25(7):4349-4357. doi: 10.1007/s00784-020-03748-w. Epub 2021 Jan 3.

  PMID: 33389135 BACKGROUND

• Cloney MB, Garcia RM, Smith ZA, Dahdaleh NS. The Effect of Steroids on Complications, Readmission, and Reoperation After Posterior Lumbar Fusion. World Neurosurg. 2018 Feb;110:e526-e533. doi: 10.1016/j.wneu.2017.11.030. Epub 2017 Nov 16.

  PMID: 29155116 BACKGROUND

• Gupta S, Jain A, Singla M. Is saltwater mouth rinse as effective as chlorhexidine following periodontal surgery? Evid Based Dent. 2021 Dec;22(4):130-131. doi: 10.1038/s41432-021-0227-6. Epub 2021 Dec 16.

  PMID: 34916636 BACKGROUND

• Huynh NC, Everts V, Leethanakul C, Pavasant P, Ampornaramveth RS. Rinsing with Saline Promotes Human Gingival Fibroblast Wound Healing In Vitro. PLoS One. 2016 Jul 21;11(7):e0159843. doi: 10.1371/journal.pone.0159843. eCollection 2016.

  PMID: 27441729 BACKGROUND

• Kalb S, Reis MT, Cowperthwaite MC, Fox DJ, Lefevre R, Theodore N, Papadopoulos SM, Sonntag VK. Dysphagia after anterior cervical spine surgery: incidence and risk factors. World Neurosurg. 2012 Jan;77(1):183-7. doi: 10.1016/j.wneu.2011.07.004. Epub 2011 Nov 15.

  PMID: 22155226 BACKGROUND

• Kim HJ, Alluri R, Stein D, Lebl D, Huang R, Lafage R, Bennett T, Lafage V, Albert T. Effect of Topical Steroid on Swallowing Following ACDF: Results of a Prospective Double-Blind Randomized Control Trial. Spine (Phila Pa 1976). 2021 Apr 1;46(7):413-420. doi: 10.1097/BRS.0000000000003825.

  PMID: 33273438 BACKGROUND

• Liu FY, Yang DL, Huang WZ, Huo LS, Ma L, Wang H, Yang SD, Ding WY. Risk factors for dysphagia after anterior cervical spine surgery: A meta-analysis. Medicine (Baltimore). 2017 Mar;96(10):e6267. doi: 10.1097/MD.0000000000006267.

  PMID: 28272237 BACKGROUND

• National Institute on Deafness and Other Communication Disorders (National Institutes of Health). Dysphagia. NIH Publication No. 10-4307. Bethesda, MD: NIH; October 2010. Available at: http://www.nidcd.nih.gov/health/voice/Pages/dysph.aspx.

  BACKGROUND

• Oh LJ, Ong S, Ghozy S, Dmytriw AA, Zuccato J, Mobbs R, Phan K, Dibas M, Faulkner H. Dysphagia rates in single- and multiple-level anterior cervical discectomy and fusion surgery: a meta-analysis. J Spine Surg. 2020 Sep;6(3):581-590. doi: 10.21037/jss-20-506.

  PMID: 33102895 BACKGROUND

• Tasiou A, Giannis T, Brotis AG, Siasios I, Georgiadis I, Gatos H, Tsianaka E, Vagkopoulos K, Paterakis K, Fountas KN. Anterior cervical spine surgery-associated complications in a retrospective case-control study. J Spine Surg. 2017 Sep;3(3):444-459. doi: 10.21037/jss.2017.08.03.

  PMID: 29057356 BACKGROUND

• Yee TJ, Swong K, Park P. Complications of anterior cervical spine surgery: a systematic review of the literature. J Spine Surg. 2020 Mar;6(1):302-322. doi: 10.21037/jss.2020.01.14.

  PMID: 32309668 BACKGROUND

Related Links

• NIH Dysphagia

MeSH Terms

Conditions

Radiculopathy; Spondylosis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ram K Alluri, M.D.

  Assistant Professor of Clinical Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Orthopaedic Surgery

Model Details: Control (no intervention) \& experimental (intervention). Both study arms will complete three (3) questionnaires at specified time points. In addition to questionnaires, the experimental group will receive an intervention of gargling warm salt water thrice daily (t.i.d.).

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 26, 2024
• Study Start: December 10, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)