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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Chronic Cancer Pain
• Intervention / Treatment: Other: TEAS; Other: sham TEAS

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Liang, PhD; Phone Number: +86-571-86633328; Email: liangyiwww@126.com

Study Locations

• China
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310053
      • Recruiting
      • The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
      • Contact: Xinyi Hu, PhD; Phone Number: +8617858655767; Email: 1837384602@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAS Intervention Group; 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.	Other: TEAS; 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.
Placebo Comparator: Sham TEAS Control Group; Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS Intervention Group.	Other: sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment.	the FACT-G comprises 27 items grouped into 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being; some items require reverse scoring, with the total score ranging from 0 to 108. Higher scores indicate better quality of life. Using the area under the curve scoring method allows for the observation of the cumulative benefit of PC-TEAS usage in patients over the entire treatment period	Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes in BPI score from baesline	The Brief Pain Inventory (BPI) is primarily used to assess pain severity and its multidimensional impact on patients' quality of life. The scale consists of two core components: BPI-S (Pain Severity) and BPI-I (Pain Interference). The BPI-S quantifies the severity of pain through four items: average pain, worst pain, least pain, and current pain intensity. The BPI-I evaluates the degree to which pain interferes with daily functioning across seven domains: mobility, activities of daily living, work, sleep, relationships with others, enjoyment of life, and mood, thereby providing a comprehensive multidimensional reflection of pain's impact on patient quality of life.Scores range from 0-10, with higher scores indicating more severe pain	Baseline; Week 4; Week 8; Week 12
Dosage of analgesics used on the assessment days	Changes in the amount of analgesic use from baseline	Baseline; Week 4; Week 8 ; Week 12
Spontaneous bowel movements (SBM) during assessment days	Spontaneous bowel movements (SBM) refer to bowel movements that occurred in the past 24 hours without the use of rescue laxatives. The number of spontaneous bowel movements by the subjects in the past week was recorded.	Baseline; Week 4; Week 8; Week 12
Bowel Function Index (BFI) during assessment days	The Bowel Function Index (BFI) is a clinical tool specifically designed to assess opioid-induced constipation. It records the patient's ratings over the past week for straining during defecation, sense of incomplete bowel evacuation, and overall satisfaction with the bowel movement process.	Baseline; Week 4; Week 8; Week 12
The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days	The Hamilton Depression Rating Scale (HAMD) is used to assess depressive. The HAMD serves as a standard clinical instrument for evaluating depressive states, In this study, participants' HAMD-17 total scores were recorded to observe changes from baseline.	Baseline; Week 4; Week 8;Week 12
The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days	The Hamilton Anxiety Scale (HAMA) is used to assess anxiety symptoms, The HAMA provides an important basis for diagnosing anxiety disorders and grading their severity. In this study, participants' HAMA scores were recorded to observe changes from baseline.	Baseline; Week 4; Week 8; Week 12
Frequency of breakthrough pain in the week preceding the assessment days	The frequency of breakthrough pain episodes, along with the types and doses of rescue medication used in the preceding week, were recorded.	Baseline; Week 4;Week 8; Week 12

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20231208064031886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No