Effects of Global Osteopathic Manual Treatments on Patients With Idiopathic Gastroparesis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Gastroparesis Cardinal Symptom index
研究概览
简要总结
Global osteopathic manual treatments will decrease the severity score of the Gastroparesis Cardinal Symptom Index tool of patients with idiopathic gastroparesis.
In this longitudinal controlled pre-test post-test group design, subjects with idiopathic gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and abdominal pain secondary to delayed gastric emptying. There is no known cause for people suffering from IG.
According to the power analysis, the population will be utilized as the experiment group and the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The subjects in the population will each fill out the GCSI initially and again after an two (2) week period to measure their symptoms during a control period. The same subjects will then be treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st) treatment (which is the last day of the control period) and then two (2) weeks after the last treatment (day 42). In order to reject the null hypothesis, with a p value of < 0.05 and a power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d = mean difference/standard deviation.
It is expected that the results will show improvement of symptoms through the data collected from the GCSI questionnaires in the treatment group. The results of this study could be significant and contribute to the osteopathic community validating the effectiveness of traditional osteopathic manual therapy as well as giving non-invasive options to people suffering from the disease since those who struggle with it have minimal treatment options--medicines with significant side effects, full or total stomach removal or gastric electrical stimulator implants.
详细描述
Gastroparesis is a disorder that presents with delayed gastric emptying, abdominal pain, nausea, and vomiting. This condition can be found in people with complications from diabetes-neuropathy of the vagus nerve and gastric surgery-damage to the vagus nerve. With idiopathic gastroparesis (IG), the cause is poorly understood with theories suggesting viral infections affecting gut motility, pyloric valve spasm as well as damage to the specialized cells within the wall of the stomach. Unfortunately the treatment options are minimal for people suffering from gastroparesis regardless of what type.
It is the action of food propulsion that is poorly understood in regards to IG - specifically smooth muscle, autonomic and enteric nerves and specialized cells in the gut named Interstitial Cells of Cajal (ICC). ICC are the pacemakers cells in the gut that conduct motility.
The objective of this study is to normalize structural abnormalities in patients with idiopathic gastroparesis with global osteopathic manual treatments, using a quantitative research method with a longitudinal controlled pre-test post-test design.
The principal investigator (PI), having a background as an emergency medicine registered nurse, has seen patients in the emergency department suffering from idiopathic gastroparesis. The acute attacks appear intense and debilitating often requiring anti-nausea, pain and anti-anxiety medications. As an osteopathic student, the PI would often wonder what could be achieved with osteopathic manual treatments (OMT) to help these people in the emergency department suffering from these symptoms.
Current treatment available for people suffering from gastroparesis is limited. In his article, Gastroparesis - Current Concepts and Considerations (2008), Dr. Hasler, summarized research and the different treatment options for gastroparesis. There are several medications available for gastroparesis however as discussed by Dr. Hasler, the side effects from these medications are significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the population is the following: English speaking females or males between the ages of 18-65 with moderate to severe IG--diagnosed by a primary physician or gastro-intestinal physician.
排除标准
- •Exclusion criteria for the population: diagnosis of gastroparesis with known cause: secondary to diabetes, post surgical or isolated disorders of motility (Parkinson's disease, non-obstructive pancreatic carcinoma, post-abdominal irradiation, atrophic gastritis, celiac arterial occlusion, Crohn's disease, Chagas disease, varicella zoster), active regular/daily marijuana users or have a diagnosis of cyclical nausea/vomiting abdominal pain secondary to regular marijuana use, alcoholics, history of gastrectomy or current gastric electrical stimulator implant, pregnancy, have any schizoaffective or borderline personality disorder, or received osteopathic manual treatment within the last year.
研究组 & 干预措施
Osteopathic manual treatment
Global Osteopathic Manual treatment: each subject will be treated according to what restrictions or areas of poor mobility are found individually. No two subjects will receive the same overall treatment.
干预措施: Global Osteopathic Manual Treatment (Other)
Control--no change in current treatment of subject
The population will act as their own control prior to intervention of osteopathy, their will be a control period where the subject maintains current treatment of their gastroparesis. During that period they will fill out the GCSI measuring tool at the beginning of the control period and at the end. Those measurements will be compared to the GSCI results during the intervention period.
结局指标
主要结局
Gastroparesis Cardinal Symptom index
时间窗: 56 days
The GCSI is a reliable and validated tool rating symptom intensity of fullness-early satiety, nausea-vomiting, and bloating. The validation of this tool was tested with 169 subjects who filled out the GCSI and those results were compared with clinician symptom ratings. Total scores of the GCSI were "responsive to changes in overall gastroparesis symptoms as assessed by clinicians.
次要结局
未报告次要终点
研究者
Kathleen Brannan Brown
RN, FNP, CMP DOMP-thesis candidate
Kathleen Brannan Brown, Inc.