Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

NCT ID: NCT03833011

Last Updated: 2019-02-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Osteopathic manipulation

Group Type EXPERIMENTAL

Osteopathic Manipulation

Intervention Type PROCEDURE

Osteopathic manipulation

Interventions

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Osteopathic Manipulation

Osteopathic manipulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MediSys Health Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Flushing Hospital

Flushing, New York, United States

Site Status

Countries

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United States

Other Identifiers

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FHMCSURG01

Identifier Type: -

Identifier Source: org_study_id

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