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Transcutaneous Electrical Acupoint Stimulation for Opioid Tolerance in Hepatocellular Carcinoma and Proteomics
Zhihui Luo1,2, Huangan Wu1,2, Jiaxi Pan1,2
1Department of Acupuncture, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Background:
The current method for managing opioid tolerance is opioid rotation, but its effectiveness is limited. Transcutaneous electrical acupoint stimulation (TEAS) combined therapy has been shown to effectively relieve moderate-to-severe pain in patients with hepatocellular carcinoma (HCC), but there is insufficient evidence regarding its role in modulating opioid tolerance. Additionally, exosomal proteomics can aid in exploring the potential mechanisms of action of TEAS.
Methods:
This single-center, patient-blinded, randomized controlled clinical trial will enroll 72 participants with moderate-to-severe cancer pain secondary to HCC. Participants will be randomly assigned to the observation group or the control group in a 1:1 ratio. On the basis of conventional Western medical analgesia, the observation group will receive TEAS treatment, while the control group will receive sham TEAS treatment. The treatment course will last for 2 weeks, followed by a 4-week follow-up period. The primary outcome is the opioid tolerance index after the treatment concludes in week 2. It quantitatively reflects the degree of opioid tolerance by measuring changes in opioid consumption over time. Secondary outcomes include the Numerical Rating Scale score, numbers of breakthrough pain, frequency of gastrointestinal side effects, quality of life evaluation, and protein biomarkers.
Conclusion:
The expected results will clarify the efficacy of TEAS in alleviating opioid tolerance in patients with moderate-to-severe HCC-related pain. Exosome proteomics can provide exploratory insights into potential mechanisms underlying the efficacy of TEAS.
Ethics And Trial Registration:
The Research Ethics Committee of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine has approved the study protocol (No. 2025-045). The trial has been registered with the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/). Registration number: ITMCTR2025002162. Registered on June 9, 2025.
