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

Abstract

Background

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

Abbreviations

BPI, Brief Pain Inventory; CIBP, Cancer induced bone pain; CR, Complete response; CRF, Case record form; CRP, Cancer-related pain; DMC, Data monitoring committee; ECT, Emission computed tomography; EDC, Electronic Data Capture; EORTC QLQ-C30, The European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients Questionnaire; GAD-7, The Generalized Anxiety Disorder; IR, Indeterminate response; NCCN, The National Comprehensive Cancer Network; NSCLC, Non-small cell lung cancer; OMED, Daily oral morphine equivalents; PCA Patient-controlled analgesia; PHQ-9, The Patient Health Questionnaire; PP, Pain progression; PR, Partial response; SAP, Statistical analysis plan; SOP, Standard operation procedure; PC-TEAS, Patient-controlled transcutaneous electrical acupoint stimulation; TENS, Transcutaneous electrical nerve stimulation; WHO, World Health Organization.

Data Sharing Statement

The data generated in this study, including the SAP and the full protocol, is available upon reasonable request. Researchers who wish to request the use of the data, along with a methodologically sound proposal, could be approved for data access by contacting the author Yi Liang via [email protected].

Ethics Approval and Consent to Participate

Approval was granted by the ethics committee of the Third Affiliated Hospital of Zhejiang Chinese Medicine University (No. ZSLL-KY-2021-021-01). Information will be provided verbally and in written form to eligible patients, and if applicable, to their legal guardians. Written informed consent will be acquired from each study participant or their legal guardian. Ongoing consent can be withdrawn at any point during the study.

Consent for Publication

Obtained.

Acknowledgments

We thank Erasmus Shannah Rose for her work in writing assistance.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This work received support from a grant provided by the Key Project of Health Science and Technology Program of National Health Commission and Zhejiang Province (Grant No. WKJ-ZJ-2436), the Key Foundation of Chinese Medicine Research Program of Zhejiang Province (2021ZZ017), the National Natural Science Foundation of China (Grant No. 82174510), and the General Scientific Research Project from the Education Department of Zhejiang Province (Grant No. Y202248799). The funding sources had no influence on the design, data collection, management, analysis, interpretation of data, or the writing of this article, nor did they affect the decision to submit it for publication.