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Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03833011
Enrollment
24
Registered
2019-02-06
Start date
2018-01-01
Completion date
2018-08-31
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Pain

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.

Interventions

Osteopathic manipulation

Sponsors

MediSys Health Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain scorepre-intervention, post-op day 1, post-op day 2subjective measure of pain on a scale of 1-10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026