Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

NCT03833011 | Completed

• 1 other identifier: FHMCSURG01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Change in pain score

  subjective measure of pain on a scale of 1-10

  pre-intervention, post-op day 1, post-op day 2

Study Arms (2)

no intervention

NO INTERVENTION

Osteopathic manipulation

EXPERIMENTAL

Procedure: Osteopathic Manipulation

Interventions

Osteopathic Manipulation PROCEDURE

Osteopathic manipulation

Osteopathic manipulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MediSys Health Network: lead

Study Sites (1)

Flushing Hospital

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: February 6, 2019
• Study Start: January 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)