Trial Summary
What is the purpose of this 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.
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.
Eligibility Criteria
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 single-approach ACDF surgery and I speak English or Spanish.
I am 18 years old or older.
+1 more
Exclusion Criteria
My health is severely limited by my illness.
I am 18 years old or younger.
My spine condition is not due to aging or unknown causes but from specific events like injury or disease.
+3 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Keck Medical Center of the University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor