The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat
A Double Blinded, Randomized Controlled Trial of the Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat
1 other identifier
interventional
168
1 country
1
Brief Summary
Post-operative sore throat (POST) ranks as the 8th most undesirable effect in the post-operative period and is noted by up to 90% of patients receiving an endotracheal tube. \[1-3\] This study aims to show that a simple 5 minute preoperative and intraoperative osteopathic medical manipulation protocol can decrease the severity and or the incidence of post-operative sore throat thereby decreasing morbidity and increasing patient satisfaction and return to daily life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2018
CompletedFirst Submitted
Initial submission to the registry
October 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedOctober 25, 2018
October 1, 2018
1.7 years
October 19, 2018
October 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post Severity
The primary outcome of this study is a decrease in the severity of Post operative sore throat. Survey questions that are measured at 1, 6, and 24 hours will be analyzed using a 2-way repeated measure ANOVA to compare the 2 randomized arms. All other data including demographic data will be compared using univariate techniques. Categorical data will be summarized using percentages and analyzed using Chi-Squared tests or Fisher's Exact test whichever is most appropriate. Means and standard deviations or medians and inter-quartile ranges will be used as summary statistics for continuous variables and they will be analyzed using Student's t-test or Wilcoxon's Test whichever most appropriate. Significance for results will be established when p-values are less than 0.05.
24 hours
Secondary Outcomes (1)
POST incidence
24 hours
Study Arms (2)
Treatment
EXPERIMENTALStudy arm who will receive pre operative and intraoperative treatments intended to effect POST severity.
Sham
SHAM COMPARATORSham are who will receive a preoperative treatment not intended to effect POST outcomes.
Interventions
All techniques with patient supine and physician at head of the bed: 1. Soft tissue massage to the posterior cervical musculature for approximately 1 minute 2. Muscle energy to the muscles of neck extension approximately 1 minute 3. Muscle energy to the Occipital Atlanto (OA) joint 1 minute 4. Muscle energy to the jaw. Approximately 1 minute 5. Occipital decompression approximately 1 minute 6. With time remaining complete another round of soft tissue massage. Intraoperative techniques: 1. Myofascial "Steering wheel" Technique 2. Sibson's Fascia Release 3. Occipital decompression
Sham protocol: Patients randomized into the sham arm of the study will undergo a controlled trial tested sham treatment that was shown to induce no statistical improvement in cervical pain or mobility with zero adverse effects with the subjects unable to tell the difference between sham and actual protocol treatment.
Eligibility Criteria
You may qualify if:
- Ages 18 and over
- ASA class 1, 2, or 3 patients
- BMI \<35
- Planned surgery \< 2.0 hours
You may not qualify if:
- Know difficult airway based on report from patient or review of previous intubation records
- Suspected difficult airway defined as two or more of the following criteria:
- Mallampati 3 or 4
- Mouth opening incisor distance less than 3cm
- Thyromental distance less than 6 cm
- Neck circumference greater than 27 inches
- Surgeries in a position other than supine
- Disease or anatomical abnormalities of the neck, larynx, or pharynx
- Post-operative mechanical ventilation needed
- Nasal intubation
- Active smokers
- Interscalene blocks
- Use of ETT adjuncts (lidocaine LTA, lubrication, etc)
- Ketamine use
- Intubation by provider with less than 100 previous intubations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Peterson, DO
Brooke Army Medcial Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Patient and Intubating Anesthesiology provider are blinded to subjects randomization into the sham treatment or protocol treatment arm of the study
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesia Resident
Study Record Dates
First Submitted
October 19, 2018
First Posted
October 25, 2018
Study Start
October 17, 2018
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
October 25, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share