Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial
Abstract Background Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-rela...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3145-y |
| _version_ | 1818279961136463872 |
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| author | Yi Liang Guanai Bao Liyan Gong Jie Zhou Xiangming Kong Ran Ran Xiaomei Shao Yongliang Jiang Weiping Zhang Boyi Liu Junying Du Junfan Fang Na Nie Conghua Ji Jianqiao Fang |
| author_facet | Yi Liang Guanai Bao Liyan Gong Jie Zhou Xiangming Kong Ran Ran Xiaomei Shao Yongliang Jiang Weiping Zhang Boyi Liu Junying Du Junfan Fang Na Nie Conghua Ji Jianqiao Fang |
| author_sort | Yi Liang |
| collection | DOAJ |
| description | Abstract Background Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-related pain. Opioid drugs are strongly recommended for treating cancer-related pain, but opioid-induced immunosuppression is still the most intractable drug-induced medical problem. Evaluating the efficacy and potential advantage of TEAS combined with opioid drugs in moderate and severe cancer-related pain in China is important because such studies are lacking. Methods/Design This trial is a multicenter, prospective randomized controlled clinical trial. In total, 160 patients who were enrolled from two hospitals in the Zhejiang Province (China) will be randomly allocated into two groups: a TEAS group and sham TEAS group without acupoint electrical stimulation. Both groups will receive a 21-day interval of chemotherapy and conventional cancer pain therapy. Fifteen treatment sessions will be performed over a three-week period. The primary outcomes will be measured by changes in the Numerical Rating Scale (NRS) scores and equivalent dosage of morphine at baseline, three weeks of treatment and one two-week follow-up. The secondary outcome measures include cellular immunity function, life quality assessment, opioids side effects assessment, and safety and compliance evaluation. Discussion This trial is expected to clarify whether TEAS is effective for cancer-related pain. These results demonstrate the advantage of TEAS combined with opioid drugs on improving immune function and decreasing opioid induced side effects. Trial registration Chinese Clinical Trial Registry, ChiCTR-13003803. Registered on 27 August 2013. |
| first_indexed | 2024-12-12T23:41:38Z |
| format | Article |
| id | doaj.art-d00838e250b84fed9ef304c94dda5419 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T23:41:38Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d00838e250b84fed9ef304c94dda54192022-12-22T00:07:07ZengBMCTrials1745-62152019-01-012011810.1186/s13063-018-3145-yEvaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trialYi Liang0Guanai Bao1Liyan Gong2Jie Zhou3Xiangming Kong4Ran Ran5Xiaomei Shao6Yongliang Jiang7Weiping Zhang8Boyi Liu9Junying Du10Junfan Fang11Na Nie12Conghua Ji13Jianqiao Fang14Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Zhejiang Cancer HospitalThe Zhejiang Cancer HospitalDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Zhejiang Cancer HospitalDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Third Clinical Medical College of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Clinical Research Institute of Zhejiang Provincial Hospital of TCMDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityAbstract Background Transcutaneous electrical acupoint stimulation (TEAS), which is also known as acupuncture-like transcutaneous electrical nerve stimulation (TENS), has been widely used in acute or chronic pain. However, previous research has not demonstrated that TEAS is effective for cancer-related pain. Opioid drugs are strongly recommended for treating cancer-related pain, but opioid-induced immunosuppression is still the most intractable drug-induced medical problem. Evaluating the efficacy and potential advantage of TEAS combined with opioid drugs in moderate and severe cancer-related pain in China is important because such studies are lacking. Methods/Design This trial is a multicenter, prospective randomized controlled clinical trial. In total, 160 patients who were enrolled from two hospitals in the Zhejiang Province (China) will be randomly allocated into two groups: a TEAS group and sham TEAS group without acupoint electrical stimulation. Both groups will receive a 21-day interval of chemotherapy and conventional cancer pain therapy. Fifteen treatment sessions will be performed over a three-week period. The primary outcomes will be measured by changes in the Numerical Rating Scale (NRS) scores and equivalent dosage of morphine at baseline, three weeks of treatment and one two-week follow-up. The secondary outcome measures include cellular immunity function, life quality assessment, opioids side effects assessment, and safety and compliance evaluation. Discussion This trial is expected to clarify whether TEAS is effective for cancer-related pain. These results demonstrate the advantage of TEAS combined with opioid drugs on improving immune function and decreasing opioid induced side effects. Trial registration Chinese Clinical Trial Registry, ChiCTR-13003803. Registered on 27 August 2013.http://link.springer.com/article/10.1186/s13063-018-3145-yStudy protocolRandomized controlled trialTEASCancer-related pain |
| spellingShingle | Yi Liang Guanai Bao Liyan Gong Jie Zhou Xiangming Kong Ran Ran Xiaomei Shao Yongliang Jiang Weiping Zhang Boyi Liu Junying Du Junfan Fang Na Nie Conghua Ji Jianqiao Fang Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial Trials Study protocol Randomized controlled trial TEAS Cancer-related pain |
| title | Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial |
| title_full | Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial |
| title_fullStr | Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial |
| title_full_unstemmed | Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial |
| title_short | Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial |
| title_sort | evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer related pain a study protocol for a randomized controlled trial |
| topic | Study protocol Randomized controlled trial TEAS Cancer-related pain |
| url | http://link.springer.com/article/10.1186/s13063-018-3145-y |
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