- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833011
Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery
Context Pain control is one of the most challenging problems encountered in postoperative period in bariatric patients. Currently there are no published studies evaluating Osteopathic Manipulative Treatment in bariatric surgery patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Flushing, New York, United States, 11355
- Flushing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Adults age 18 and older eligible for bariatric surgery as per American Society for Metabolic and Bariatric Surgery guidelines:
- 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:
- Age less than 18.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: no intervention
|
|
Experimental: Osteopathic manipulation
|
Osteopathic manipulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain score
Time Frame: pre-intervention, post-op day 1, post-op day 2
|
subjective measure of pain on a scale of 1-10
|
pre-intervention, post-op day 1, post-op day 2
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FHMCSURG01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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