Effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Quality of Life in Chronic Cancer Pain
NCT ID: NCT07308951
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
290 participants
INTERVENTIONAL
2025-09-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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);
18 Years
80 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Yi Liang
Director
Locations
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The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
Zhejiang, Hangzhou, China
Countries
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Central Contacts
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Facility Contacts
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Xinyi Hu, PhD
Role: primary
Other Identifiers
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20231208064031886
Identifier Type: -
Identifier Source: org_study_id