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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
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Time frame: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
Scleroderma Health Assessment Questionnaire will be used to assess SSc symptoms
Time frame: 70 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Time frame: 1 day
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Time frame: 28 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Time frame: 42 days
effect of TEA on symptoms in Systemic Sclerosis (SSc) patients
SF-36 questionnaire will be used to assess general quality of life
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 70 days
effects of TEA on gastric motility
visit 1 in acute phase; gastric slow waves recording
Time frame: 1 week
effects of TEA on gastric motility
visit 2 in acute phase; gastric slow waves recording
Time frame: 2 weeks
effects of TEA on gastric motility
visit 3 in acute phase; gastric slow waves recording
Time frame: 3 weeks
effects of TEA on gastric motility
visit 4 in acute phase; gastric slow waves recording
Time frame: 4 weeks
effects of TEA on autonomic function
visit 1 in acute phase; heart rate variability recording
Time frame: 1 week
effects of TEA on autonomic function
visit 2 in acute phase; heart rate variability recording
Time frame: 2 weeks
effects of TEA on autonomic function
visit 3 in acute phase; heart rate variability recording
Time frame: 3 weeks
effects of TEA on autonomic function
visit 4 in acute phase; heart rate variability recording
Time frame: 4 weeks
effects of TEA on gastric motility
visit 1 in chronic phase; gastric slow waves recording
Time frame: 1 day
effects of TEA on gastric motility
visit 2 in chronic phase; gastric slow waves recording
Time frame: 28 days
effects of TEA on gastric motility
visit 3 in chronic phase; gastric slow waves recording
Time frame: 42 days
effects of TEA on gastric motility
visit 4 in chronic phase; gastric slow waves recording
Time frame: 70 days
effects of TEA on gastric motility
visit 1 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 1 day
effects of TEA on gastric motility
visit 2 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 28 days
effects of TEA on gastric motility
visit 3 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 42 days
effects of TEA on gastric motility
visit 4 in chronic phase; breath test will be used to assess gastric emptying
Time frame: 70 days
effects of TEA on autonomic function
visit 1 in chronic phase; heart rate variability recording
Time frame: 1 day
effects of TEA on autonomic function
visit 2 in chronic phase; heart rate variability recording
Time frame: 28 days
effects of TEA on autonomic function
visit 3 in chronic phase; heart rate variability recording
Time frame: 42 days
effects of TEA on autonomic function
visit 4 in chronic phase; heart rate variability recording
Time frame: 70 days
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time frame: 1 day
effects of TEA on autonomic function
visit 2 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time frame: 28 days
effects of TEA on autonomic function
visit 3 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey will be used to assess autonomic function
Time frame: 42 days
effects of TEA on autonomic function
visit 1 in chronic phase; Composite Autonomic Symptoms Score (COMPASS) 31 survey visit 4 in chronic phase; will be used to assess autonomic function
Time frame: 70 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
baseline before the study; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
30 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
60 minutes after the testing meal; NE (indication of sympathetic activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
baseline before the study; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
30 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 1 day
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 28 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 42 days
effects of TEA on autonomic function
60 minutes after the testing meal; pancreatic polypeptide (PP, indication of vagal activity) will be assessed using ELISA autonomic function.
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; vasoactive intestinal peptide (VIP)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; vasoactive intestinal peptide (VIP)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Time frame: day 1
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-10 (IL-10)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-10 (IL-10)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interferon α(IFNα)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interferon α(IFNα)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interferon α(IFNα)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-1 beta (IL-1β)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-1 beta (IL-1β)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; interleukin-6 (IL-6)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; interleukin-6 (IL-6)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: day 1
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
baseline before the study; tumor necrosis factor alpha(TNFα)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
30 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 70 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 1 day
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 28 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 42 days
effects of TEA on GI hormones and inflammatory cytokine
60 minutes after the testing meal; tumor necrosis factor alpha(TNFα)
Time frame: 70 days