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CompletedNCT03833011Updated Feb 8, 2019

Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery

An interventional study of Osteopathic Manipulation in Pain and Bariatric Surgery Candidate, sponsored by MediSys Health Network. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by MediSys Health Network · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2018, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Bariatric Surgery Candidate
03

In context

Lead sponsor

MediSys Health Network is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • No intervention
    no intervention
  • Experimental
    Osteopathic manipulation

    Procedure: Osteopathic Manipulation

Interventions

  • ProcedureOsteopathic Manipulation

    Osteopathic manipulation

06

What researchers measure

Primary outcomes

  1. Change in pain score

    subjective measure of pain on a scale of 1-10

    Time frame: pre-intervention, post-op day 1, post-op day 2

07

Study locations

1 site
  • Flushing Hospital
    Flushing, New York 11355, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03833011
Lead sponsor
MediSys Health Network
Responsible party
Sponsor
First posted
Feb 6, 2019
Start date
Jan 1, 2018
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018
Last update
Feb 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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