Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Age less than
- •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
研究组 & 干预措施
Osteopathic manipulation
干预措施: Osteopathic Manipulation (Procedure)
no intervention
结局指标
主要结局
Change in pain score
时间窗: pre-intervention, post-op day 1, post-op day 2
subjective measure of pain on a scale of 1-10
次要结局
未报告次要终点