Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery
NCT ID: NCT03833011
Last Updated: 2019-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2018-01-01
2018-08-31
Brief Summary
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Objective The primary objective of this study is to determine whether Osteopathic Manipulative Treatment (OMT) can decrease pain score in bariatric patients. The secondary objective is whether OMT can improve patient satisfaction with overall treatment.
Design: A prospective randomized group controlled study.
Setting: A 293-bed non-for-profit teaching community hospital.
Methods Thirty-six patients scheduled for bariatric surgery as per ASMBS criteria were eligible for study from January 2017 through August 2018 at Flushing Hospital Medical Center, New York. Twelve patients were excluded.
Twenty-four patients were included into study and randomized to receive OMT(n=12) vs Control (n=12) intervention.
In Control group, patients received standard pain control protocol with morphine patient controlled analgesia pump (PCA) In OMT group, patients received standard postoperative pain protocol and OMT on postoperative day one. Three techniques were used (Sub-occipital Release, Thoracic Outlet Release, and Rib Raising). All patients received survey to complete prior to discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good, excellent) and data was analyzed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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no intervention
No interventions assigned to this group
Osteopathic manipulation
Osteopathic Manipulation
Osteopathic manipulation
Interventions
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Osteopathic Manipulation
Osteopathic manipulation
Eligibility Criteria
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Inclusion Criteria
* BMI of at least 40, or greater than 100 pounds overweight.
* BMI of 35 or above and at least one or more obesity-related comorbidity such as type II diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease, or osteoarthritis.
* Inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts.
Exclusion Criteria
* Pregnant patients.
* Patients with history of chronic pain.
* Patients with diagnosed psychiatric disorders.
* Patients actively taking pain medication before surgery.
* Patients with prior surgical history
18 Years
ALL
No
Sponsors
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MediSys Health Network
OTHER
Responsible Party
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Locations
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Flushing Hospital
Flushing, New York, United States
Countries
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Other Identifiers
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FHMCSURG01
Identifier Type: -
Identifier Source: org_study_id
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