Recruiting

Global Osteopathic Manual Treatments

Sponsor:

Kathleen Brannan Brown, Inc.

Code:

NCT02232334

Conditions

Idiopathic Gastroparesis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Global Osteopathic Manual Treatment

Study Details

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

Study ID

NCT02232334

Start date

Sep, 2014

Status verified date

Mar, 2015

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Global Osteopathic Manual Treatment

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.

Primary outcome measure

  • Gastroparesis Cardinal Symptom index [ Time Frame: 56 days ]

Central Contacts and Locations

Central contacts

Kathleen B Brown, MSN, DOMP-candidate

707-659-6090Kathleenbrannanbrown@gmail.com

Locations

Kathleen Brannan Brown INC

Recruiting

Santa Rosa, California, United States, 95404

Contacts

Kathleen B Brown, MSN, DOMP candidate

7076596090kathleenbrannanbrown@gmail.com

More Information

Sponsor

Kathleen Brannan Brown, Inc.

Last update posted

Apr 1, 2015

Last verified

Mar, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kathleen Brannan Brown, Inc. on 2015-04-01.