Trial Outcomes & Findings for Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders (NCT NCT04349891)
NCT ID: NCT04349891
Last Updated: 2024-09-19
Results Overview
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
TERMINATED
NA
27 participants
Up to 10 weeks
2024-09-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention - 4 Weeks
STARTED
|
15
|
12
|
|
First Intervention - 4 Weeks
COMPLETED
|
11
|
7
|
|
First Intervention - 4 Weeks
NOT COMPLETED
|
4
|
5
|
|
Washout - 2 Weeks
STARTED
|
11
|
7
|
|
Washout - 2 Weeks
COMPLETED
|
10
|
7
|
|
Washout - 2 Weeks
NOT COMPLETED
|
1
|
0
|
|
Second Intervention - 4 Weeks
STARTED
|
10
|
7
|
|
Second Intervention - 4 Weeks
COMPLETED
|
8
|
7
|
|
Second Intervention - 4 Weeks
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention - 4 Weeks
Withdrawal by Subject
|
3
|
4
|
|
First Intervention - 4 Weeks
Adverse Event
|
1
|
1
|
|
Washout - 2 Weeks
Withdrawal by Subject
|
1
|
0
|
|
Second Intervention - 4 Weeks
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Baseline characteristics by cohort
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=15 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=12 Participants
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.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 2 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
BMI
|
24.34 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
22.01 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 10 weeksPopulation: The number of participants analyzed are the ones who completed each study intervention.
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
Outcome measures
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=11 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=7 Participants
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.
|
|---|---|---|
|
Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score
First Intervention
|
2.60 score on a scale
Standard Deviation 0.88
|
2.84 score on a scale
Standard Deviation 1.21
|
|
Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score
Washout
|
2.58 score on a scale
Standard Deviation 0.81
|
2.74 score on a scale
Standard Deviation 1.21
|
|
Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score
Second intervention
|
2.22 score on a scale
Standard Deviation 0.58
|
2.84 score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Patients who provided data at the end of each study intervention.
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements.
Outcome measures
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=11 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=7 Participants
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.
|
|---|---|---|
|
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
|
11.45 number of bowel movements
Standard Deviation 17.02
|
|
Change in Number of Spontaneous Complete Bowel Movements
Washout - end of 6th week
|
12.88 number of bowel movements
Standard Deviation 22.84
|
11.07 number of bowel movements
Standard Deviation 12.93
|
|
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
|
10.68 number of bowel movements
Standard Deviation 11.76
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Patients who provided data at the end of each study intervention.
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.
Outcome measures
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=11 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=7 Participants
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.
|
|---|---|---|
|
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
|
17.30 score on a scale
Standard Deviation 10.74
|
|
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
|
16.21 score on a scale
Standard Deviation 11.12
|
|
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
|
17.03 score on a scale
Standard Deviation 10.68
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Patients who provided data at the end of each study intervention.
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.
Outcome measures
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=11 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=7 Participants
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.
|
|---|---|---|
|
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
|
1.40 score on a scale
Standard Deviation 0.50
|
|
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
|
1.42 score on a scale
Standard Deviation 0.53
|
|
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
|
1.41 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Patients who provided data at the end of each study intervention.
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.
Outcome measures
| Measure |
TEA at ST36 and PC6 First and Then Sham TEA
n=15 Participants
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.
|
Sham-TEA and Then TEA ST36 and PC6
n=12 Participants
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.
|
|---|---|---|
|
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
|
51.21 score on a scale
Standard Deviation 9.70
|
|
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
|
50.95 score on a scale
Standard Deviation 8.74
|
|
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
|
54.17 score on a scale
Standard Deviation 7.72
|
Adverse Events
TEA at ST36 and PC6
Sham - TEA
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TEA at ST36 and PC6
n=22 participants at risk
Patients in this group received TEA at ST36 and PC6 for 4 weeks
|
Sham - TEA
n=22 participants at risk
Patients in this group received sham-TEA for 4 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
4.5%
1/22 • Number of events 1 • Up to 10 weeks
Serious Adverse Events and All-cause mortality were not collected.
|
4.5%
1/22 • Number of events 1 • Up to 10 weeks
Serious Adverse Events and All-cause mortality were not collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place