Degeneration SpineNCT06475365
Salt Water Gargling on Swallowing Following ACDF
A study testing Sodium chloride gargle in people with Degeneration Spine and Cervical Radiculopathy, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degeneration Spine, Cervical Radiculopathy, Cervical Stenosis
- What is being tested?
- Sodium chloride gargle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Keck Medical Center of the University of Southern California
Los Angeles, California, 90089
About this study
Official title: The Effect of Salt Water Gargling on Swallowing Dysfunction Following Multi-Level Anterior Cervical Discectomy and Fusion (ACDF): A Randomized Control 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.
Read more
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.
Read the detailed 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:
- Patients will be screened using the general inclusion/exclusion parameters
- Patients will be randomized into one of two groups: control or experimental using a 1:1 ratio
- Patients will complete three (3) questionnaires at selected time points throughout the study duration
- 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
- Patients in the control arm will only be asked to complete the scheduled questionnaires
Required questionnaires:
- Swallow Quality of Life Questionnaire (SWAL-QOL)
- Visual Analogue Scale - Neck (VAS Neck)
- 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.
- Conditions
- Degeneration Spine, Cervical Radiculopathy, Cervical Stenosis, Cervical Spondylosis, Cervical Myelopathy, Dysphagia
- Being tested
- Sodium chloride gargle
- Keywords
- ACDF, Anterior cervical discectomy & fusion, Cervical spine, Dysphagia
- Medical subject headings
- Radiculopathy, Spondylosis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium chloride gargleOther
Also called Salt water gargle
15mL salt water gargle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sodium chloride gargle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 - 1 month
Secondary outcomes (1)
Neck Disability Index (NDI) Score of 30 to 100
On the NDI, a scores of ranging from 30 - 100 are indicative of mild to severe disability with respect to function of the neck. This will be used to assess if there is a correlation between a high SWAL-QOL score and a high NDI score.
Measured: 0 - 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start10 Dec 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Degeneration SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Alluri, University of Southern California
- Investigators
- Ram K Alluri, M.D., Principal investigator, Assistant Professor of Clinical Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475365
- Sponsor's protocol ID
- HS-24-00348
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28377867Anderson 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.
PubMed 24436882Campbell 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.
PubMed 21492571Collins 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.
PubMed 33389135Cloney 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.
PubMed 29155116Gupta 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.
PubMed 34916636Huynh 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.
PubMed 27441729Kalb 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.
PubMed 22155226Kim 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.
PubMed 33273438Liu 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.
PubMed 28272237National 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.
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.
PubMed 33102895Tasiou 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.
PubMed 29057356Yee 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.
PubMed 32309668
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salt Water Gargling on Swallowing Dysfunction Following Multi-Level Anterior Cervical Discectomy and Fusion (ACDF): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06475365
- Acronym / sponsor ID
- HS-24-00348
- Conditions
- Degeneration Spine, Cervical Radiculopathy, Cervical Stenosis, Cervical Spondylosis, Cervical Myelopathy, Dysphagia
- Keywords
- ACDF, Anterior cervical discectomy & fusion, Cervical spine, Dysphagia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Patients will be screened using the general inclusion/exclusion parameters
- Patients will be randomized into one of two groups: control or experimental using a 1:1 ratio
- Patients will complete three (3) questionnaires at selected time points throughout the study duration
- 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
- Patients in the control arm will only be asked to complete the scheduled questionnaires
Required questionnaires:
- Swallow Quality of Life Questionnaire (SWAL-QOL)
- Visual Analogue Scale - Neck (VAS Neck)
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.).
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Sodium chloride gargleAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride gargleAlso: Salt water gargle15mL salt water gargle | Other | Salt Water Gargle |
Primary outcome
Number of Participants with a SWAL-QOL Score of Greater Than 14
Time frame: 0 - 1 month
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.
1 secondary outcome
Neck Disability Index (NDI) Score of 30 to 100
Time frame: 0 - 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Results publication: PubMed 28377867Adenikinju 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.
- Results publication: PubMed 24436882Anderson 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.
- Results publication: PubMed 21492571Campbell 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.
- Results publication: PubMed 33389135Collins 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.
- Results publication: PubMed 29155116Cloney 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.
- Results publication: PubMed 34916636Gupta 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.
- Results publication: PubMed 27441729Huynh 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.
- Results publication: PubMed 22155226Kalb 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.
- Results publication: PubMed 33273438Kim 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.
- Results publication: PubMed 28272237Liu 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.
- Results publicationNational 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.
- Results publication: PubMed 33102895Oh 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.
- NIH DysphagiaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ram K Alluri, M.D. principal investigator
Assistant Professor of Clinical Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium chloride gargle in people with Degeneration Spine and Cervical Radiculopathy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a SWAL-QOL Score of Greater Than 14 (time frame: 0 - 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06475365, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.