Recruiting

Osteopathic Manipulation

Sponsor:

Brooke Army Medical Center

Code:

NCT03720301

Conditions

Pharyngitis

Dysphonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Osteopathic Manipulation Treatment

Sham

Study Details

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.

Conditions

Pharyngitis

Dysphonia

Study ID

NCT03720301

Start date

Oct 17, 2018

Status verified date

Oct, 2018

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Jun 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 18 and over
  • ASA class 1, 2, or 3 patients
  • BMI <35
  • Planned surgery < 2.0 hours

Exclusion Criteria:

  • 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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

Study arm who will receive pre operative and intraoperative treatments intended to effect POST severity.

sham comparator: Sham

Sham are who will receive a preoperative treatment not intended to effect POST outcomes.

Interventions

Osteopathic Manipulation Treatment

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

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.

Primary outcome measure

  • Post Severity [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Kevin C Peterson, DO

2109168335kevin.c.peterson3.mil@mail.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Kevin Peterson, DO

210-916-8335kevin.c.peterson3.mil@mail.mil

Principal Investigator:

Kevin Peterson, DO

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Oct 25, 2018

Last verified

Oct, 2018

Keywords

  • Sore Throat
  • Osteopathic Manipulation
  • Post operative sore throat
  • Endotracheal tube

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2018-10-25.