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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Quality of Life; Chronic Cancer Pain

Treatments: Other: TEAS; Other: sham TEAS

Study type: Interventional

Funder types: Other

Identifiers

NCT07308951

20231208064031886

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups, including a placebo group

TEAS Intervention Group

Experimental group

Description:

First, acupoint group ① (bilateral Hegu \[LI4\] and Neiguan \[PC6\]) received 30 minutes of transcutaneous electrical acupoint stimulation (TEAS), followed by acupoint group ② (bilateral Sanyinjiao \[SP6\] and Zusanli \[ST36\]) for the same duration.

Treatment:

Other: TEAS

Sham TEAS Control Group

Placebo Comparator group

Description:

Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS Intervention Group.

Treatment:

Other: sham TEAS