RecruitingNot ApplicableNCT07308951

Effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Quality of Life in Chronic Cancer Pain

Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Enrollment

290 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Quality of Life Chronic Cancer Pain

Summary

This study aims to objectively evaluate the effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation (PC-TEAS) on improving the quality of life in patients with chronic cancer pain, thereby providing evidence-based medical support for its efficacy and offering practical basis for patients to achieve home-based auxiliary treatment based on their own needs. Furthermore, by observing and comparing changes in indicators such as pain-related scores, analgesic consumption, emotional scores, spontaneous bowel movements, and adverse events, this research will comprehensively assess the advantages of PC-TEAS in the management of chronic cancer pain and explore other potential benefits of this intervention for patients.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Age between 18 and 80 years, regardless of gender;
Diagnosis of primary or metastatic malignant tumor confirmed by histopathology and/or cytology, consistent with the American Cancer Society criteria for malignancy;
Presence of cancer-related pain, defined as an average Numeric Rating Scale (NRS) score ≥ 2 over the preceding week or current regular use of opioid analgesics;
Life expectancy ≥ 3 months;
Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score ≤ 2, stable vital signs, clear consciousness, intact pain perception, unimpaired communication, ability to cooperate with study procedures and complete assessments;
Provision of signed informed consent by the patient or their legal guardian after comprehensive explanation of the study;

Exclusion Criteria7

Pain not attributable to cancer;
Severe cardiopulmonary dysfunction or respiratory depression;
Implantation of cardiac pacemaker or metallic implants at stimulation sites;
Local skin lesions or conditions unsuitable for TEAS at the acupoint sites;
Severe psychiatric disorders or significant cognitive impairment;
Concurrent participation in other clinical trials that may interfere with the outcome evaluation of this study;
Previous history of transcutaneous electrical acupoint stimulation (TEAS) or transcutaneous electrical nerve stimulation (TENS);

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Interventions

OTHERTEAS

Patients assumed a supine or sitting position, and after routine skin disinfection at the acupoint sites, one pair of electrode patches was attached to the two ipsilateral acupoints of the same group, with the same procedure performed on the contralateral side. A transcutaneous electrical acupoint stimulator was used to apply TEAS sequentially to acupoint groups ① and ②. Each acupoint group received a single TEAS session lasting 30 minutes. Participants were permitted to undergo multiple TEAS sessions within the same day, with all treatments recorded in a pain diary. The TEAS parameters were set as a continuous wave at a frequency of 2 Hz, with the current intensity adjusted to the patient's tolerance level. The treatment followed a "patient-controlled, as-needed" administration pattern. Each treatment course lasted 7 days, with a minimum of 3 treatment days per course and a total of no fewer than 5 sessions per course. A total of 4 treatment courses were conducted.

OTHERsham TEAS

Participants were informed that, due to individual variations in sensory thresholds, it is normal if no distinct sensation is perceived even at the maximum stimulation intensity. Regardless of subjective perception, the transcutaneous electrical acupoint stimulation treatment remains active and exerts its therapeutic effects continuously.