Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis

Status unconfirmed · Not applicable

Conditions studied: Idiopathic Gastroparesis

In brief

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.

Key facts

Study ID

NCT02232334

Run by

Kathleen Brannan Brown, Inc.

People needed

12

Starts

2014-09-01

Expected to finish

2016-07-01

Last updated by the study team

2015-04-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kathleen Brannan Brown INC — Santa Rosa, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.