Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma
1 other identifier
interventional
23
1 country
1
Brief Summary
An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2017
CompletedFirst Submitted
Initial submission to the registry
August 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2019
CompletedNovember 26, 2019
November 1, 2019
2.4 years
August 18, 2017
November 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the first visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the second visit; The validated "University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0" (UCLA SCTC GIT2.0) for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
On the third visit; The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
The validated UCLA SCTC GIT2.0 ("University of California at Los Angeles Scleroderma Clinical Trials Consortium Gastro-Intestinal Tract Instrument version 2.0") for SSc will be the primary outcome measurement; it includes 7 categories: reflux, distention and bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
a validated method including 9 symptoms will be used to assess GI symptoms
70 days
Secondary Outcomes (120)
effects of TEA on gastric motility
1 week
effects of TEA on gastric motility
2 weeks
effects of TEA on gastric motility
3 weeks
effects of TEA on gastric motility
4 weeks
effects of TEA on autonomic function
1 week
- +115 more secondary outcomes
Study Arms (3)
scleroderma patients-0
EXPERIMENTALfor acute study: The experiment in patients will be performed in 4 randomized sessions on separate days (at least 3 days apart): one control session with sham-TEA and 3 TEA sessions at various parameters. TEA will be applied on both acupoints ST36 and PC6; the following sets of parameters will be tested for TEA at ST36: A) standard parameters: the set used in the previous SSc study: 25 Hz, 0.3ms, 2s-on and 3s-off; B) same as A but pulse width of 0.6ms; C) same as B but 0.1s-on and 0.4s-off. For TEA at PC6, 25 Hz will be replaced by 100Hz because TEA at PC6 is used to treat symptoms and 100Hz is believed to be better than 25Hz. The patient will be fasted overnight, and the test will last 2 hours (1 hour fasting and 1 hour postprandial).
scleroderma patient-1
EXPERIMENTALfor chronic study: 2 weeks of Sham transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
scleroderma patients-2
EXPERIMENTALfor chronic study: 2 weeks of transcutaneous electroacupuncture treatment, 2 weeks of wash out, 2 weeks of transcutaneous electroacupuncture/Sham transcutaneous electroacupuncture treatment. Best parameter gained from acute study will be used.
Interventions
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Eligibility Criteria
You may qualify if:
- No any systemic diseases;
- no scleroderma; no history of gastrointestinal surgery;
- no dyspeptic symptoms during the past 2 weeks;
- not taking any medications except contraceptives during the past 2 weeks;
- age 18 and older.
You may not qualify if:
- History of any systemic diseases or surgeries;
- allergic to adhesives; pregnancy;
- unable to sign the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiande Chen, Ph.D
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2017
First Posted
September 27, 2017
Study Start
February 6, 2017
Primary Completion
June 30, 2019
Study Completion
November 20, 2019
Last Updated
November 26, 2019
Record last verified: 2019-11