Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Pain Clinical Trial

Official title:

Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833011
• Other study ID #: FHMCSURG01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2019
• Source: MediSys Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Pain

Intervention

Procedure:
• Osteopathic Manipulation
Osteopathic manipulation

Locations

Country	Name	City	State
United States	Flushing Hospital	Flushing	New York

Sponsors (1)

Lead Sponsor	Collaborator
MediSys Health Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain score	subjective measure of pain on a scale of 1-10	pre-intervention, post-op day 1, post-op day 2