The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk.
A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk.
Honghui hospital
Xi'an, Shaanxi, China
RECRUITINGSecond Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGTangdu Hospital
Xi'an, Shaanxi, China
RECRUITINGClinical response
decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1
Time frame: 8 weeks
Change from baseline in the Mayo score
Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome.
Time frame: 8 weeks
Endoscopic remission
defined as Mayo endoscopic score ≤ 1
Time frame: 8 weeks
Clinical remission
overall score ≤2 \[and no individual subscore \>1\]
Time frame: 8 weeks
Symptomatic remission
Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0
Time frame: 2, 4, 6, and 8 weeks
Fecal calprotectin
fecal sample
Time frame: 4 and 8 weeks
erythrocyte sedimentation rate
blood sample
Time frame: 4 and 8 weeks
C reactive protein
blood sample
Time frame: 4 and 8 weeks
pancreatic polypeptide
blood sample
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Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGTime frame: 4 and 8 weeks
norepinephrine
blood sample
Time frame: 4 and 8 weeks
acetyl choline
blood sample
Time frame: 4 and 8 weeks
acetyl choline
Intestinal mucosal tissue sample
Time frame: 8 weeks
alpha7 nicotinic acetylcholine receptor
Intestinal mucosal tissue sample
Time frame: 8 weeks
Inflammatory Bowel Disease Questionnaire Score
The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Time frame: 4 and 8 weeks
Hospital Anxiety and Depression scale score
anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.
Time frame: 4 and 8 weeks
Pittsburgh sleep quality index
The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome.
Time frame: 4 and 8 weeks
autonomic profile characteristics
heart rate variability indicating sympathetic and parasympathetic activity
Time frame: 4 and 8 weeks