Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis

NCT02232334 | Unknown

• 1 other identifier: Brown - 1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Gastroparesis

Keywords

Idiopathic Gastroparesis, Nausea, Vomiting, Abdominal Pain, Gastrectomy, Osteopathy, Gastroparesis Cardinal Symptom Index, GCSI

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom index

  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.

  56 days

Study Arms (2)

Osteopathic manual treatment

EXPERIMENTAL

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.

Other: Global Osteopathic Manual Treatment

Control--no change in current treatment of subject

NO 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.

Interventions

Global Osteopathic Manual Treatment OTHER

subtle manipulations of the body according to the methodology of osteopathic manual therapy will be the intervention on subjects in the study. The global treatments will take into consideration the past medical history of each subject as well as what is found on assessment. Focus is on the position, mobililty and quality of each subjects anatomy.

Osteopathic manual treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Kathleen Brannan Brown, Inc.: lead

Study Sites (1)

Kathleen Brannan Brown INC

Santa Rosa, California, 95404, United States

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting; Abdominal Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Central Study Contacts

Kathleen B Brown, MSN, DOMP-candidate

CONTACT

707-659-6090; Kathleenbrannanbrown@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, FNP, CMP DOMP-thesis candidate

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)