Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Pain
• Interventions: Procedure: Osteopathic Manipulation

• Registration Number: NCT03833011
• Lead Sponsor: MediSys Health Network

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Study First Submitted: 2019-01-18
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-06
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic manipulation	Osteopathic Manipulation	-

Primary Outcome Measures

Name	Time	Method
Change in pain score	pre-intervention, post-op day 1, post-op day 2	subjective measure of pain on a scale of 1-10

Trial Locations

Locations (1)

Flushing Hospital; 🇺🇸 Flushing, New York, United States