Salt Water Gargling on Swallowing Following ACDF
- Conditions
- Degeneration SpineCervical SpondylosisCervical RadiculopathyCervical MyelopathyCervical StenosisDysphagia
- Interventions
- Other: Sodium chloride gargle
- Registration Number
- NCT06475365
- Lead Sponsor
- University of Southern California
- 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.
- 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:
1. Patients will be screened using the general inclusion/exclusion parameters
2. Patients will be randomized into one of two groups: control or experimental using a 1:1 ratio
3. Patients will complete three (3) questionnaires at selected time points throughout the study duration
4. 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
5. Patients in the control arm will only be asked to complete the scheduled questionnaires
Required questionnaires:
1. Swallow Quality of Life Questionnaire (SWAL-QOL)
2. Visual Analogue Scale - Neck (VAS Neck)
3. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Salt Water Gargle Sodium chloride gargle 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.
- Primary Outcome Measures
Name Time Method Number of Participants with a SWAL-QOL Score of Greater Than 14 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.
- Secondary Outcome Measures
Name Time Method Neck Disability Index (NDI) Score of 30 to 100 0 - 1 month 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.
Trial Locations
- Locations (1)
Keck Medical Center of the University of Southern California
🇺🇸Los Angeles, California, United States