Effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Quality of Life in Chronic Cancer Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEAS, sham TEAS.
- Who it may be relevant to
- Registry conditions: Quality of Life, Chronic Cancer Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain
Overview
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.
Interventions
- 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 se - 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.
Primary outcome measures
- 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. [Time frame: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12]
Secondary outcome measures (7)
- the changes in BPI score from baesline [Time frame: Baseline; Week 4; Week 8; Week 12]
- Dosage of analgesics used on the assessment days [Time frame: Baseline; Week 4; Week 8 ; Week 12]
- Spontaneous bowel movements (SBM) during assessment days [Time frame: Baseline; Week 4; Week 8; Week 12]
- Bowel Function Index (BFI) during assessment days [Time frame: Baseline; Week 4; Week 8; Week 12]
- The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days [Time frame: Baseline; Week 4; Week 8;Week 12]
- The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days [Time frame: Baseline; Week 4; Week 8; Week 12]
- Frequency of breakthrough pain in the week preceding the assessment days [Time frame: Baseline; Week 4;Week 8; Week 12]
Eligibility criteria
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);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Zhejiang
Identifiers
NCT: NCT07308951 · 20231208064031886