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Completed

NCT Number: 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.

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Key information

Conditions

Pain Bariatric Surgery Candidate Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flushing Hospital

Flushing, New York, 11355, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulation

Procedure

Osteopathic manipulation

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

MediSys Health Network

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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