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The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks. |
|
| shame group | Placebo Comparator | Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical acustimulation at treatment sites | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Endoscopic remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wan | Contact | +8615529202305 | 408127528@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Kaichun Wu | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honghui hospital | Recruiting | Xi'an | Shaanxi | 710000 | China |
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|
|
| transcutaneous electrical acustimulation at sham sites | Device | 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. |
|
|
defined as Mayo endoscopic score ≤ 1
| 8 weeks |
| Clinical remission | overall score ≤2 [and no individual subscore >1] | 8 weeks |
| Symptomatic remission | Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0 | 2, 4, 6, and 8 weeks |
| Fecal calprotectin | fecal sample | 4 and 8 weeks |
| erythrocyte sedimentation rate | blood sample | 4 and 8 weeks |
| C reactive protein | blood sample | 4 and 8 weeks |
| pancreatic polypeptide | blood sample | 4 and 8 weeks |
| norepinephrine | blood sample | 4 and 8 weeks |
| acetyl choline | blood sample | 4 and 8 weeks |
| acetyl choline | Intestinal mucosal tissue sample | 8 weeks |
| alpha7 nicotinic acetylcholine receptor | Intestinal mucosal tissue sample | 8 weeks |
| Inflammatory Bowel Disease Questionnaire Score | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome | 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. | 4 and 8 weeks |
| Pittsburgh sleep quality index | The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome. | 4 and 8 weeks |
| autonomic profile characteristics | heart rate variability indicating sympathetic and parasympathetic activity | 4 and 8 weeks |
| Second Affiliated Hospital of Xi 'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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