Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial
Zhengyi Lyu,1,* Qiongying Shen,1,* Shuxin Tian,1,* Liyan Gong,2 Haizhou Lou,3 Guanai Bao,2 Zhuoxuan Wu,3 Chao Lu,2 Weiping Zhang,4 Rui Huang,5 Conghua Ji,6 Siyi Zheng,1 Wei Pan,1 Yinyin Ying,4 Jianwei Jin,4 Yi Liang4 1The Third Clinical Medical College of Zhejiang Chinese Med...
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| Language: | English |
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Dove Medical Press
2024-03-01
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| Series: | Journal of Pain Research |
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| Online Access: | https://www.dovepress.com/effects-of-patient-controlled-transcutaneous-electrical-acupoint-stimu-peer-reviewed-fulltext-article-JPR |
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| author | Lyu Z Shen Q Tian S Gong L Lou H Bao G Wu Z Lu C Zhang W Huang R Ji C Zheng S Pan W Ying Y Jin J Liang Y |
| author_facet | Lyu Z Shen Q Tian S Gong L Lou H Bao G Wu Z Lu C Zhang W Huang R Ji C Zheng S Pan W Ying Y Jin J Liang Y |
| author_sort | Lyu Z |
| collection | DOAJ |
| description | Zhengyi Lyu,1,* Qiongying Shen,1,* Shuxin Tian,1,* Liyan Gong,2 Haizhou Lou,3 Guanai Bao,2 Zhuoxuan Wu,3 Chao Lu,2 Weiping Zhang,4 Rui Huang,5 Conghua Ji,6 Siyi Zheng,1 Wei Pan,1 Yinyin Ying,4 Jianwei Jin,4 Yi Liang4 1The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China; 2Zhejiang Cancer Hospital, Hangzhou, Zhejiang, People’s Republic of China; 3Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, People’s Republic of China; 4Department of Acupuncture, the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China; 5Department of Acupuncture and Tuina, Wenzhou Central Hospital, Wenzhou, Zhejiang, People’s Republic of China; 6Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yi Liang, Department of Acupuncture, the Third Affiliated Hospital of Zhejiang Chinese Medical University, 219 Moganshan Road, Hangzhou City, Zhejiang Province, 310053, People’s Republic of China, Email liangyiwww@126.comBackground: Transcutaneous Electrical Acupoint Stimulation (TEAS) therapy opens up the possibility for individuals with Cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. The aim of this study is designed to evaluate the efficacy of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC).Methods/Design: This is a study protocol for a prospective, triple-blind, randomized controlled trial. We anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The true group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this investigation is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, quality of life scale, mood scales, and routine blood counts on the assessment days. Any adverse events will be promptly addressed and reported if they occur. We will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight.Discussion: PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture and to explore a safe and effective integrative medicine scheme for CIBP.Trial Registration: ClinicalTrials.gov NCT05730972, registered February 16, 2023.Keywords: bone cancer pain, TEAS, transcutaneous electrical nerve stimulation, patient-controlled analgesia, integrative medicine, home-based treatment |
| first_indexed | 2024-04-24T18:56:12Z |
| format | Article |
| id | doaj.art-68345bbca6224b6bb3b4ffc3b5b3135c |
| institution | Directory Open Access Journal |
| issn | 1178-7090 |
| language | English |
| last_indexed | 2024-04-24T18:56:12Z |
| publishDate | 2024-03-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Pain Research |
| spelling | doaj.art-68345bbca6224b6bb3b4ffc3b5b3135c2024-03-26T17:28:02ZengDove Medical PressJournal of Pain Research1178-70902024-03-01Volume 171285129891518Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled TrialLyu ZShen QTian SGong LLou HBao GWu ZLu CZhang WHuang RJi CZheng SPan WYing YJin JLiang YZhengyi Lyu,1,* Qiongying Shen,1,* Shuxin Tian,1,* Liyan Gong,2 Haizhou Lou,3 Guanai Bao,2 Zhuoxuan Wu,3 Chao Lu,2 Weiping Zhang,4 Rui Huang,5 Conghua Ji,6 Siyi Zheng,1 Wei Pan,1 Yinyin Ying,4 Jianwei Jin,4 Yi Liang4 1The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China; 2Zhejiang Cancer Hospital, Hangzhou, Zhejiang, People’s Republic of China; 3Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, People’s Republic of China; 4Department of Acupuncture, the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China; 5Department of Acupuncture and Tuina, Wenzhou Central Hospital, Wenzhou, Zhejiang, People’s Republic of China; 6Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yi Liang, Department of Acupuncture, the Third Affiliated Hospital of Zhejiang Chinese Medical University, 219 Moganshan Road, Hangzhou City, Zhejiang Province, 310053, People’s Republic of China, Email liangyiwww@126.comBackground: Transcutaneous Electrical Acupoint Stimulation (TEAS) therapy opens up the possibility for individuals with Cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. The aim of this study is designed to evaluate the efficacy of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC).Methods/Design: This is a study protocol for a prospective, triple-blind, randomized controlled trial. We anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The true group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this investigation is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, quality of life scale, mood scales, and routine blood counts on the assessment days. Any adverse events will be promptly addressed and reported if they occur. We will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight.Discussion: PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture and to explore a safe and effective integrative medicine scheme for CIBP.Trial Registration: ClinicalTrials.gov NCT05730972, registered February 16, 2023.Keywords: bone cancer pain, TEAS, transcutaneous electrical nerve stimulation, patient-controlled analgesia, integrative medicine, home-based treatmenthttps://www.dovepress.com/effects-of-patient-controlled-transcutaneous-electrical-acupoint-stimu-peer-reviewed-fulltext-article-JPRbone cancer painteastranscutaneous electrical nerve stimulationpatient-controlled analgesiaintegrative medicinehome-based treatment |
| spellingShingle | Lyu Z Shen Q Tian S Gong L Lou H Bao G Wu Z Lu C Zhang W Huang R Ji C Zheng S Pan W Ying Y Jin J Liang Y Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial Journal of Pain Research bone cancer pain teas transcutaneous electrical nerve stimulation patient-controlled analgesia integrative medicine home-based treatment |
| title | Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial |
| title_full | Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial |
| title_fullStr | Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial |
| title_short | Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial |
| title_sort | effects of patient controlled transcutaneous electrical acupoint stimulation on cancer induced bone pain relief in patients with non small cell lung cancer study protocol for a randomized controlled trial |
| topic | bone cancer pain teas transcutaneous electrical nerve stimulation patient-controlled analgesia integrative medicine home-based treatment |
| url | https://www.dovepress.com/effects-of-patient-controlled-transcutaneous-electrical-acupoint-stimu-peer-reviewed-fulltext-article-JPR |
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