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Transcutaneous electrical acupoint stimulation for cancer-related pain management in patients receiving chronic opioid therapy: a randomized clinical trial

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Abstract

Purpose

The opioid crisis resulting from its use disorder and overdose poses additional challenges for cancer pain management. The American Society of Clinical Oncology Practice Guideline recommends acupuncture therapy for the management of adult cancer-related pain (CRP), but the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on CRP remains uncertain.

Methods

This 5-week prospective randomized clinical trial was conducted at 2 hospitals in China, and participants with CRP receiving chronic opioid therapy were randomized 1:1 into two groups between December 2014 and June 2018. The true TEAS group underwent 15 sessions of TEAS treatments over 3 consecutive weeks, while the control group received sham stimulation. The primary outcome was the numerical rating scale (NRS) score in the past 24h at week 3. The secondary outcomes included morphine equivalent daily dose, quality of life and adverse events.

Results

A total of 159 participants were included in the modified intention-to-treat population. The baseline characteristics were similar in both groups. The mean NRS scores were 0.98 points at week 3 in the true TEAS group and 1.41 points in the sham group, with the mean difference between groups of -0.43 points (P < 0.001; OR = 0.68, P < 0.05). The proportion of patients with NRS reduction more than thirty percentage at week 3 was 50.00% in the true TEAS group and 35.44% in the sham group (RD = 0.15, P > 0.05; RR = 1.41, P > 0.05). No significant difference in pain intensity between the two groups was observed during the follow-up period without TEAS intervention (week 4, OR = 0.83, P > 0.05; week 5, OR = 0.83, P > 0.05). The Karnofsky Performance Status value suggested that patients in the true TEAS group experienced an improved quality of life (Between-group differences: week 3, 3.5%, P < 0.05; week 4, 4.6%, P < 0.001; week 5, 5.6%, P < 0.001).

Conclusions

The 3-week application of TEAS in patients with CRP receiving chronic opioid therapy resulted in a statistically significant reduction in pain scores, but the observed reduction was of uncertain clinical significance. The prolonged analgesic effect of TEAS was not confirmed in this trial.

ClinicalTrial.gov

ChiCTR-TRC-13003803.

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Data availability

The data generated in this study, including deidentified participant data and the data dictionary, are available upon reasonable request. Researchers interested in accessing the data for valid research purposes can contact the corresponding author, Yi Liang, at liangyiwww@126.com, with a methodologically sound proposal. Requests will be subject to review and approval.

Abbreviations

CRP:

Cancer-related pain

EQ-5D-3L:

Three-level version of EuroQol five-dimensional questionnaire

KPS:

The Karnofsky Performance Status

MEDD:

Morphine equivalent daily dose

mITT:

Modified intention-to-treat

NRS:

Numerical rating scale

QoL:

Quality of life

TEAS:

Transcutaneous electrical acupoint stimulation

TENS:

Transcutaneous electrical nerve stimulation

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Acknowledgements

We extend our gratitude to Professor Mao and her team from the School of Public Health at Zhejiang Chinese Medicine University for their valuable statistical support. We would like to thank Erasmus Shannah Rose for the language review of this paper. Additionally, we appreciate the dedication of the medical and nursing staff at the trial sites, as well as the patients who participated in the study.

Funding

This work received financial support from the Key Project of Health Science and Technology Program of National Health Commission and Zheiang Province (WKJ-ZI-2436 to YLiang), the Key Foundation of Chinese Medicine Research Program of Zhejiang Province (2021ZZ017 to Yi Liang), and the General Medical Science and Technology Project of Zhejiang Province (2014KYA162 to Yi Liang), and the Graduate Student Scientific Research Fund Project of Zhejiang Chinese Medicine University (2023YKJ01 to Yi Liang). The funding source played no role in the study design, data collection and analyses, decision to publish or preparation of the manuscript.

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Authors and Affiliations

  1. The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, 310005, China

    Zhengyi Lyu, Shuxin Tian & Yang Liu

  2. Department of Integrated Chinese Traditional Medicine and Western Medicine, Zhejiang Cancer Hospital, Hangzhou, 310022, China

    Guanai Bao, Liyan Gong & Xiangming Kong

  3. Department of Acupuncture and Tuina, Wenzhou Central Hospital, Wenzhou, 325000, China

    Rui Huang

  4. Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China

    Jie Zhou, Na Nie, Xiaomei Shao, Xianming Lin, Jianqiao Fang & Yi Liang

  5. Department of Oncology, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, 310000, China

    Weiping Zhang & Ran Ran

  6. Zhejiang Chinese Medical University, Hangzhou, 310005, China

    Conghua Ji & Guoyin Kai

  7. Department of Clinical Evaluation Center, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, 310000, China

    Shan Liu

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Contributions

Yi Liang and Jianqiao Fang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Zhengyi Lyu, Shuxin Tian and Guanai Bao contributed equally as first authors to this work. Concept and design: Yi Liang, Jianqiao Fang, Liyan Gong, Xiangming Kong, Weiping Zhang. Acquisition, analysis, or interpretation of data: Guanai Bao, Zhengyi Lyu, Yang Liu, Shan Liu, Jie Zhou, Conghua Ji, Ran Ran, Nie Na. Drafting of the manuscript: Zhengyi Lyu, Shuxin Tian, Rui Huang. Revising of the manuscript: Yi Liang, Guoyin Kai, Jianqiao Fang. Statistical analysis: Shuxin Tian, Shan Liu, Conghua Ji. Obtained funding: Yi Liang, Jianqiao Fang. Administrative, technical, or material support: Xianming Lin, Xiaomei Shao, Weiping Zhang. Supervision: Yi Liang, Weiping Zhang, Liyan Gong. All authors read and approved the final manuscript.

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Correspondence to Jianqiao Fang or Yi Liang.

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The authors declare no competing interests.

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Ethical approval for this trial was granted by the medical ethics committee of the Third Affiliated Hospital of Zhejiang Chinese Medical University [2014–09-86 (Ke)].

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All study participants signed informed consent forms.

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Zhengyi Lyu, Shuxin Tian, and Guanai Bao contributed equally as first authors to this work.

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Lyu, Z., Tian, S., Bao, G. et al. Transcutaneous electrical acupoint stimulation for cancer-related pain management in patients receiving chronic opioid therapy: a randomized clinical trial. Support Care Cancer 32, 16 (2024). https://doi.org/10.1007/s00520-023-08240-1

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