Gastroparesis
Conditions
Brief summary
Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human. Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients. The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.
Interventions
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
DEVICESham TEA
Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
for FD patients * Bothersome postprandial fullness * Symptoms of early satiation, epigastric pain, epigastric burning during the last 3 months * No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms. * Males and females between ages 18-80 yrs; * Subjects with high probability for compliance and completion of the study. Inclusion criteria for chronic constipation patients * Satisfying Rome IV criteria for diagnosis of functional constipation; * abdominal X-ray or anorectal manometry test during the past 3 months indicating delayed colonic transit (more than 20% ingested markers are retained) or abnormal colonic motility; * ages 18-80 years; * no constipation medication for a minimum of 1 week before enrollment except for rescue agents (stimulant laxatives, such as bisacodyl); * willing to comply with the treatment regimen. Inclusion criteria for gastroparesis patients * At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms); * Abnormal gastric emptying diagnosed during the past year; * Males and females between ages 18-80 yrs; * Subjects with high probability for compliance and completion of the study. * Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
Exclusion criteria
* History of gastric bezoar or diverticulitis. * Severe daily abdominal pain requiring narcotic medications. * Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery. * Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy; * Surgery within the past 3 months. * Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test). * Those who have been treated with acupuncture or those who are familiar with acupuncture points. * Anyone with an implantable cardiac pacemaker or defibrillator. * unable to give informed consent; * taking prokinetics, anticholinergic or dopaminergic agents; * history of gastrointestinal surgery; * pregnant or preparing to conceive a child; * diabetes; * allergic to skin preparation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | Up to 10 weeks | The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe). GCSI total score can range from 0 to 5, with higher scores reflecting greater symptom severity. The |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Spontaneous Complete Bowel Movements | Up to 10 weeks | The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements. |
| Change in the Patient Assessment of Constipation (PAC-SYN) Score | Up to 10 weeks | The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of Patient Assessment of Constipation (PAC-SYN). This questionnaire asks about constipation in the past 2 weeks. Symptoms include: abdominal discomfort, abdominal pain, bloating, stomach cramps, painful bowel movements, rectal burning, rectal bleeding, incomplete bowel movement, hardness of stool, size of bowel movements, straining and feeling to pass a bowel without success. Each symptom will be scored between 1 to 4 being 1 for mild symptoms; 2 for moderate; 3 for severe and 4 for very severe. A total PAC-SYM score ranges from 0 to 48 with a low score indicating fewer symptoms and of lower severity. |
| Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | Up to 10 weeks | The effect of TEA on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QoL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL). There is not an established PAC-QOL score for the diagnosis of constipation. |
| Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | Up to 10 weeks | The effect of TEA on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The subscales will be combined to report average mean score. |
Countries
United States
Participant flow
Pre-assignment details
Once the inclusion and exclusion criteria were satisfied, patients were assigned randomly to either the treatment group or the sham group. No subjects were excluded prior to the assignment of participants to their respective groups.
Participants by arm
| Arm | Count |
|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA Patients in this group will be treated with TEA at ST36 and PC6 for 4 weeks, followed with a 2-week washout period and another 4-week period with sham TEA.
Transcutaneous Electroacupuncture: Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
Sham TEA: Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. | 15 |
| Sham-TEA and Then TEA ST36 and PC6 Patients in this group will be treated with sham-TEA for 4 weeks, followed with a 2-week washout period and another 4-week period with TEA at ST36 and PC6.
Transcutaneous Electroacupuncture: Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
Sham TEA: Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. | 12 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention - 4 Weeks | Adverse Event | 1 | 1 |
| First Intervention - 4 Weeks | Withdrawal by Subject | 3 | 4 |
| Second Intervention - 4 Weeks | Withdrawal by Subject | 2 | 0 |
| Washout - 2 Weeks | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | TEA at ST36 and PC6 First and Then Sham TEA | Sham-TEA and Then TEA ST36 and PC6 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 10 Participants | 25 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 7.5 | 40.9 years STANDARD_DEVIATION 2 | 37.2 years STANDARD_DEVIATION 5.5 |
| BMI | 24.34 kg/m^2 STANDARD_DEVIATION 5.7 | 22.01 kg/m^2 STANDARD_DEVIATION 4.8 | 22.8 kg/m^2 STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 12 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 12 Participants | 26 Participants |
| Region of Enrollment United States | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1 / 22 | 1 / 22 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe). GCSI total score can range from 0 to 5, with higher scores reflecting greater symptom severity. The
Time frame: Up to 10 weeks
Population: The number of participants analyzed are the ones who completed each study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | Second intervention | 2.22 score on a scale | Standard Deviation 0.58 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | First Intervention | 2.60 score on a scale | Standard Deviation 0.88 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | Washout | 2.58 score on a scale | Standard Deviation 0.81 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | First Intervention | 2.84 score on a scale | Standard Deviation 1.21 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | Washout | 2.74 score on a scale | Standard Deviation 1.21 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score | Second intervention | 2.84 score on a scale | Standard Deviation 1.14 |
Secondary
Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey
The effect of TEA on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The subscales will be combined to report average mean score.
Time frame: Up to 10 weeks
Population: Patients who provided data at the end of each study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | Wash out - End of 6th week. | 43.21 score on a scale | Standard Deviation 8.66 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | Second intervention - End of 10th week | 44.47 score on a scale | Standard Deviation 11.45 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | First Intervention - End of 4th Week | 45.83 score on a scale | Standard Deviation 9.63 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | First Intervention - End of 4th Week | 51.21 score on a scale | Standard Deviation 9.7 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | Wash out - End of 6th week. | 50.95 score on a scale | Standard Deviation 8.74 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey | Second intervention - End of 10th week | 54.17 score on a scale | Standard Deviation 7.72 |
Secondary
Change in Number of Spontaneous Complete Bowel Movements
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements.
Time frame: Up to 10 weeks
Population: Patients who provided data at the end of each study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Number of Spontaneous Complete Bowel Movements | First intervention - end of the 4th week of study participation. | 8.79 number of bowel movements | Standard Deviation 13.74 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Number of Spontaneous Complete Bowel Movements | Washout - end of 6th week | 12.88 number of bowel movements | Standard Deviation 22.84 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Number of Spontaneous Complete Bowel Movements | Second intervention - end of the 10th week. | 9.38 number of bowel movements | Standard Deviation 10.46 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Number of Spontaneous Complete Bowel Movements | First intervention - end of the 4th week of study participation. | 11.45 number of bowel movements | Standard Deviation 17.02 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Number of Spontaneous Complete Bowel Movements | Washout - end of 6th week | 11.07 number of bowel movements | Standard Deviation 12.93 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Number of Spontaneous Complete Bowel Movements | Second intervention - end of the 10th week. | 10.68 number of bowel movements | Standard Deviation 11.76 |
Secondary
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
The effect of TEA on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QoL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL). There is not an established PAC-QOL score for the diagnosis of constipation.
Time frame: Up to 10 weeks
Population: Patients who provided data at the end of each study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | Washout - End of 6th week. | 1.86 score on a scale | Standard Deviation 0.62 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | Second intervention - End of the 10th week. | 1.72 score on a scale | Standard Deviation 0.56 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | First intervention - End of 4th week. | 1.76 score on a scale | Standard Deviation 0.64 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | Washout - End of 6th week. | 1.42 score on a scale | Standard Deviation 0.53 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | First intervention - End of 4th week. | 1.40 score on a scale | Standard Deviation 0.5 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale | Second intervention - End of the 10th week. | 1.41 score on a scale | Standard Deviation 0.5 |
Secondary
Change in the Patient Assessment of Constipation (PAC-SYN) Score
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of Patient Assessment of Constipation (PAC-SYN). This questionnaire asks about constipation in the past 2 weeks. Symptoms include: abdominal discomfort, abdominal pain, bloating, stomach cramps, painful bowel movements, rectal burning, rectal bleeding, incomplete bowel movement, hardness of stool, size of bowel movements, straining and feeling to pass a bowel without success. Each symptom will be scored between 1 to 4 being 1 for mild symptoms; 2 for moderate; 3 for severe and 4 for very severe. A total PAC-SYM score ranges from 0 to 48 with a low score indicating fewer symptoms and of lower severity.
Time frame: Up to 10 weeks
Population: Patients who provided data at the end of each study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Patient Assessment of Constipation (PAC-SYN) Score | First Intervention - End of the 4th week | 17.14 score on a scale | Standard Deviation 8.31 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Patient Assessment of Constipation (PAC-SYN) Score | Washout - End of 6th week | 16.83 score on a scale | Standard Deviation 9.64 |
| TEA at ST36 and PC6 First and Then Sham TEA | Change in the Patient Assessment of Constipation (PAC-SYN) Score | Second Intervention - End of 10th week | 13.9 score on a scale | Standard Deviation 8.47 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Patient Assessment of Constipation (PAC-SYN) Score | First Intervention - End of the 4th week | 17.30 score on a scale | Standard Deviation 10.74 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Patient Assessment of Constipation (PAC-SYN) Score | Washout - End of 6th week | 16.21 score on a scale | Standard Deviation 11.12 |
| Sham-TEA and Then TEA ST36 and PC6 | Change in the Patient Assessment of Constipation (PAC-SYN) Score | Second Intervention - End of 10th week | 17.03 score on a scale | Standard Deviation 10.68 |