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PI left Johns Hopkins University
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEA at ST36 and PC6 first and then sham TEA | Experimental | 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. |
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| Sham-TEA and then TEA ST36 and PC6 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electroacupuncture | Device | Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 weeks |
| Change in the Patient Assessment of Constipation (PAC-SYN) Score |
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Inclusion criteria for FD patients
Inclusion criteria for chronic constipation patients
Inclusion criteria for gastroparesis patients
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Pasricha, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention - 4 Weeks |
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| Washout - 2 Weeks |
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| Second Intervention - 4 Weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The number of participants analyzed are the ones who completed each study intervention. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
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Up to 10 weeks
Serious Adverse Events and All-cause mortality were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEA at ST36 and PC6 | Patients in this group received TEA at ST36 and PC6 for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Pasricha | Mayo Clinic Arizona | (480)301-4279 | pasricha.jay@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2022 | Jul 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2022 | Jul 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| Sham TEA | Device | Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. |
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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. |
| Up to 10 weeks |
| 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. | Up to 10 weeks |
| 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. | Up to 10 weeks |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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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. |
| OG001 | 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. |
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| 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. | Patients who provided data at the end of each study intervention. | Posted | Mean | Standard Deviation | number of bowel movements | Up to 10 weeks |
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| 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. | Patients who provided data at the end of each study intervention. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
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| 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. | Patients who provided data at the end of each study intervention. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
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| 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. | Patients who provided data at the end of each study intervention. | Posted | Mean | Standard Deviation | score on a scale | Up to 10 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| 1 |
| 22 |
| EG001 | Sham - TEA | Patients in this group received sham-TEA for 4 weeks | 0 | 0 | 0 | 0 | 1 | 22 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Washout - end of 6th week |
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| Second intervention - end of the 10th week. |
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| Washout - End of 6th week |
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| Second Intervention - End of 10th week |
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| Washout - End of 6th week. |
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| Second intervention - End of the 10th week. |
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| Wash out - End of 6th week. |
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| Second intervention - End of 10th week |
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