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

NCT07308951 | Recruiting DMC

• 1 other identifier: 20231208064031886
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Chronic Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• the changes in BPI score from baesline

  Baseline; Week 4; Week 8; Week 12

• Dosage of analgesics used on the assessment days

  Baseline; Week 4; Week 8 ; Week 12

• Spontaneous bowel movements (SBM) during assessment days

  Baseline; Week 4; Week 8; Week 12

• Bowel Function Index (BFI) during assessment days

  Baseline; Week 4; Week 8; Week 12

• The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days

  Baseline; Week 4; Week 8;Week 12

Study Arms (2)

TEAS Intervention Group

EXPERIMENTAL

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

Sham TEAS Control Group

PLACEBO COMPARATOR

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

Interventions

TEAS OTHER

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.

TEAS Intervention Group

sham TEAS OTHER

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.

Sham TEAS Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

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

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medicinal University

Zhejiang, Hangzhou, 310053, China

RECRUITING

Central Study Contacts

Yi Liang, PhD

CONTACT

+86-571-86633328; liangyiwww@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 30, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)