Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2014 |
| End Date: | July 2016 |
| Contact: | Kathleen B Brown, MSN, DOMP-candidate |
| Email: | Kathleenbrannanbrown@gmail.com |
| Phone: | 707-659-6090 |
Effects of Global Osteopathic Manual Treatments on Patients With Idiopathic Gastroparesis
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.
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.
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.
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.
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.
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