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Behavioural Intervention

Osteopathic manual treatment for Gastroparesis

N/A
Waitlist Available
Research Sponsored by Kathleen Brannan Brown, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Gastroparesis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gastroparesis Cardinal Symptom index

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Osteopathic manual treatmentExperimental Treatment1 Intervention
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.
Group II: Control--no change in current treatment of subjectActive Control1 Intervention
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.

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Who is running the clinical trial?

Kathleen Brannan Brown, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Apr 2025