Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial
Abstract Background Previous studies have shown that electroacupuncture (EA) reduces the severity of acute pancreatitis. However, the effect of EA for pain relief in patients with acute pancreatitis has not been evaluated yet. The purpose of this study was to prove the efficacy of EA for pain relief...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-05-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2644-1 |
| _version_ | 1818129825248837632 |
|---|---|
| author | Dong Kee Jang Chan Yung Jung Kyung Ho Kim Jun Kyu Lee |
| author_facet | Dong Kee Jang Chan Yung Jung Kyung Ho Kim Jun Kyu Lee |
| author_sort | Dong Kee Jang |
| collection | DOAJ |
| description | Abstract Background Previous studies have shown that electroacupuncture (EA) reduces the severity of acute pancreatitis. However, the effect of EA for pain relief in patients with acute pancreatitis has not been evaluated yet. The purpose of this study was to prove the efficacy of EA for pain relief in patients with acute pancreatitis compared with conventional treatment. Methods This study is a randomized, controlled, three-arm, parallel-group, multi-center trial. Patients diagnosed with acute pancreatitis are enrolled and randomly assigned to EA 1, EA 2, or a control group in a 1:1:1 ratio. All the enrolled patients basically receive the conventional standard-of-care therapy for acute pancreatitis. Local EA is given in group EA 1, while local with additional distal EA is given in group EA 2. Local EA includes two acupoints, Zhong Wan (CV12) and Shang Wan (CV13), located in the abdomen, while distal EA includes 12 peripheral acupoints, Zhong Wan (CV12), Shang Wan (CV13), He Gu (LI4), Nei Guan (PC6), San Yin Jiao (SP6), Xuan Zhong (GB39), Zu San Li (ST36), and Shang Ju Xu (ST37). The patients randomized to the EA 1 and EA 2 groups undergo one session of EA daily from day 1 until day 4, or until pain resolves. The primary endpoint is the Visual Analog Scale (VAS) change for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, time to pain disappearance, and hospital days. Discussion The results of this trial are expected to prove the efficacy of EA for pain relief in patients with acute pancreatitis. Based upon the results, EA would be applied to a variety of clinical practices for reducing pain. Trial registration This trial is registered at ClinicalTrials.gov, ID: NCT03173222. Registered on 1 August 2017. |
| first_indexed | 2024-12-11T07:55:18Z |
| format | Article |
| id | doaj.art-2fa2cbc3f2fb412b80e24059d685078c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T07:55:18Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2fa2cbc3f2fb412b80e24059d685078c2022-12-22T01:15:15ZengBMCTrials1745-62152018-05-011911610.1186/s13063-018-2644-1Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trialDong Kee Jang0Chan Yung Jung1Kyung Ho Kim2Jun Kyu Lee3Department of Internal Medicine, Dongguk University College of Medicine, Dongguk University Ilsan HospitalInstitute of Oriental Medicine, College of Korean Medicine, Dongguk UniversityDepartment of Acupuncture and Moxibustion, Dongguk University College of Korean Medicine, Dongguk University Ilsan Oriental HospitalDepartment of Internal Medicine, Dongguk University College of Medicine, Dongguk University Ilsan HospitalAbstract Background Previous studies have shown that electroacupuncture (EA) reduces the severity of acute pancreatitis. However, the effect of EA for pain relief in patients with acute pancreatitis has not been evaluated yet. The purpose of this study was to prove the efficacy of EA for pain relief in patients with acute pancreatitis compared with conventional treatment. Methods This study is a randomized, controlled, three-arm, parallel-group, multi-center trial. Patients diagnosed with acute pancreatitis are enrolled and randomly assigned to EA 1, EA 2, or a control group in a 1:1:1 ratio. All the enrolled patients basically receive the conventional standard-of-care therapy for acute pancreatitis. Local EA is given in group EA 1, while local with additional distal EA is given in group EA 2. Local EA includes two acupoints, Zhong Wan (CV12) and Shang Wan (CV13), located in the abdomen, while distal EA includes 12 peripheral acupoints, Zhong Wan (CV12), Shang Wan (CV13), He Gu (LI4), Nei Guan (PC6), San Yin Jiao (SP6), Xuan Zhong (GB39), Zu San Li (ST36), and Shang Ju Xu (ST37). The patients randomized to the EA 1 and EA 2 groups undergo one session of EA daily from day 1 until day 4, or until pain resolves. The primary endpoint is the Visual Analog Scale (VAS) change for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, time to pain disappearance, and hospital days. Discussion The results of this trial are expected to prove the efficacy of EA for pain relief in patients with acute pancreatitis. Based upon the results, EA would be applied to a variety of clinical practices for reducing pain. Trial registration This trial is registered at ClinicalTrials.gov, ID: NCT03173222. Registered on 1 August 2017.http://link.springer.com/article/10.1186/s13063-018-2644-1Acute pancreatitisElectroacupuncturePain managementAbdominal pain |
| spellingShingle | Dong Kee Jang Chan Yung Jung Kyung Ho Kim Jun Kyu Lee Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial Trials Acute pancreatitis Electroacupuncture Pain management Abdominal pain |
| title | Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial |
| title_full | Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial |
| title_fullStr | Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial |
| title_full_unstemmed | Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial |
| title_short | Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial |
| title_sort | electroacupuncture for abdominal pain relief in patients with acute pancreatitis study protocol for a randomized controlled trial |
| topic | Acute pancreatitis Electroacupuncture Pain management Abdominal pain |
| url | http://link.springer.com/article/10.1186/s13063-018-2644-1 |
| work_keys_str_mv | AT dongkeejang electroacupunctureforabdominalpainreliefinpatientswithacutepancreatitisstudyprotocolforarandomizedcontrolledtrial AT chanyungjung electroacupunctureforabdominalpainreliefinpatientswithacutepancreatitisstudyprotocolforarandomizedcontrolledtrial AT kyunghokim electroacupunctureforabdominalpainreliefinpatientswithacutepancreatitisstudyprotocolforarandomizedcontrolledtrial AT junkyulee electroacupunctureforabdominalpainreliefinpatientswithacutepancreatitisstudyprotocolforarandomizedcontrolledtrial |