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

Официальное название

Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12]

Вторичные конечные точки (7)

• the changes in BPI score from baesline [Срок оценки: Baseline; Week 4; Week 8; Week 12]
• Dosage of analgesics used on the assessment days [Срок оценки: Baseline; Week 4; Week 8 ; Week 12]
• Spontaneous bowel movements (SBM) during assessment days [Срок оценки: Baseline; Week 4; Week 8; Week 12]
• Bowel Function Index (BFI) during assessment days [Срок оценки: Baseline; Week 4; Week 8; Week 12]
• The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days [Срок оценки: Baseline; Week 4; Week 8;Week 12]
• The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days [Срок оценки: Baseline; Week 4; Week 8; Week 12]
• Frequency of breakthrough pain in the week preceding the assessment days [Срок оценки: Baseline; Week 4;Week 8; Week 12]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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);

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Zhejiang

Идентификаторы

NCT: NCT07308951 · 20231208064031886

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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