Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis

Idiopathic Gastroparesis Clinical Trial

Official title:

Effects of Global Osteopathic Manual Treatments on Patients With Idiopathic Gastroparesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02232334
• Other study ID #: Brown - 1
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2014
• Last updated: March 30, 2015
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: March 2015
• Source: Kathleen Brannan Brown, Inc.
• Contact: Kathleen B Brown, MSN, DOMP-candidate
• Phone: 707-659-6090
• Email: Kathleenbrannanbrown[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

There are invasive treatments, such as injection of botulinum toxin into the pyloric sphincter, gastric electrical stimulator and gastric resection which have shown some improvement in symptoms but carry heavy risks if utilized.

The research method used to determine if global osteopathic manual treatments can help patients who suffer from idiopathic gastroparesis is a longitudinal pre-test post-test controlled quantitative study. The tool used to measure data is the Gastroparesis Cardinal Index Score (GCSI), which was created by Janssen Global Services, LLC. 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 (P = 0.0002) and patients (P = 0.002).

A minimum of ten (10) subjects are required for the population according to the power analysis, and at lease twelve (12) subjects will be enrolled to account for the potential 20% drop out rate. However, (20) twenty subjects will be the goal for recruitment for this study. Approval from an Institutional Review Board (IRB) has been acquired through Aspire-IRB, gastroenterologists and family medicine physicians in the Sonoma County and Santa Rosa California area will be given recruitment letters and consent forms with study information to give to patients who qualify for the study. Flyers will be distributed throughout the community (grocery stores, community centers, pharmacies etc.). Social media might be utilized to acquire subjects as there appears to be a strong presence of support groups online of people with gastroparesis.

The entire population, during the control group period, will fill out the GCSI initially and then again at two (2) weeks. Those subjects will transition to the experimental group period of the study-the GCSI filled out on the last day of the control period will be used as the first day of treatment GCSI results. IN the experiment period: the subjects will receive three (3) separate global osteopathic manual treatments over four (4) weeks (day 1, 14, and 28). Two weeks after the third (3rd) treatment (day 42), the subjects will fill out the GCSI a final time. The subjects are waiting two (2) weeks to allow for full integration of the last treatment and the GCSI is designed to record the prior two (2) weeks of patients symptoms.

The subjects in the population will be screened via email and or telephone assuring they meet the inclusion/exclusion criteria. Once consented, each participant will be instructed to fill out the first (1st) GCSI questionnaires and email the completed form back to the PI. The data of the first GCSI completion establishes day one (1) of the two (2) week control period. During the two (2) week control period, subjects are to continue their regular treatments for IG (dietary, medicine). They are not to obtain any new therapies such as massage, acupuncture, osteopathy or start any new conventional medical treatments. If there is an acute attack requiring an emergency room visit, the subject will have to be excluded from the study. At the end of the two (2) week period, those subjects will fill out the GCSI again and those results will be anonymously stored for future data analysis. The subjects then will be transitioned into the experimental period and assigned to have their first treatment. The last day of the control period will start the experimental period. All treatments will occur at the office/clinic of the PI in Santa Rosa California, USA. The PI will be working under her massage practitioner license with malpractice insurance under Associated Bodywork and Massage Professionals (ABMP) as well as Manual Therapy Insurance Plus through the Barral Institute. Both of these institutions cover general and professional liability for massage therapy as well as various forms of manual therapy.

At the first treatment, day one (1) of the experimental period, the GCSI (Appendix A) and health history questionnaire (Appendix I) will have been completed. An anamnesis will be taken and the subject will then be assessed and treated with a global osteopathic manual treatment to treat the lesions found in the assessment. The data from the GCSI will be collected and stored anonymously for data analysis. The lesions found in assessment and techniques used to treat will be stored for use in discussion if appropriate. The process will be repeated at two (2) weeks and four (4) weeks from the first (1st) visit for each participant except without the GCSI and without the health questionnaire as it is only required on the first visit. Each treatment will last ninety (90) minutes. To keep results as consistent as possible, subjects will be seen at the same time of the day for each treatment. The results from two (2) weeks and four (4) weeks will be stored for possible discussion. To allow time for integration of the treatments each participant will fill out the GCSI two (2) weeks after the fourth (4th) week of the experimental period. The data from all GCSI tools filled out from the control and experimental periods will be sent to the PI via email for data analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastroparesis
• Idiopathic Gastroparesis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Kathleen Brannan Brown INC	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Kathleen Brannan Brown, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No