The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain

Официальное название

Patient-Controlled Transcutaneous Acupoint Electrical Stimulation to Improve Quality of Life in Patients With Cancer Pain

Обзор

The conduct of a pilot trial is of great significance as a means of assessing the feasibility and harmonization of the research and is a very necessary precursor to the better conduct of formal trials. The primary aim of this pilot study is to assess the feasibility of a PC-TEAS in improving the quality of life of cancer patients with pain, with the aspiration of providing process evidence base and an assessment of the intervention for conducting a formal trial. the secondary outcome is to assess the clinical efficacy of the PC-TEAS.

Вмешательства

• Другое Transcutaneous electrical acupoint stimulation
  The 4 patches of the transcutaneous acupoint electrical stimulator were pasted on two pairs of acupuncture points, the output frequency was adjusted to 2Hz, the intensity was up to 50ma, the single intervention time was 30 minutes, and another group of acupuncture points was replaced after completion, and the rest of the operations were the same as above, with a total intervention time of 1 hour.
• Другое sham Transcutaneous electrical acupoint stimulation
  The patch is fixed on the acupuncture point to turn on the instrument, but there is no current output

Первичные конечные точки

• Trial feasibility [Срок оценки: week 4]

Вторичные конечные точки (6)

• the changes of EORTC QLQ-C30 score from baseline [Срок оценки: week 4, week 8, week 12]
• the changes in BPI score of mean pain, severe Pain, least pain and current pain from baesline [Срок оценки: week 4, week 8, week 12]
• the amounts of analgesics used [Срок оценки: week 4, week 8, week 12]
• Index of spontaneous bowel movements [Срок оценки: week 4, week 8, week 12]
• The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D) [Срок оценки: week 4, week 8, week 12]
• The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A) [Срок оценки: week 4, week 8, week 12]

Критерии участия

Participants who had been diagnosed with cancer pain were eligible if they ①were 18 to 75 years old, ②had NRS pain score of ≥4 in the previous 1 week, or had regular use of analgesics, ③ anticipated survival of at least 6 months, ④ECOG-PS score ≤2 points, ⑤stable vital signs, clear consciousness, and the ability to correctly judge their pain, communication is unhindered, able to cooperate with researchers to complete relevant research assessments, ⑥voluntarily participate in this study and sign the informed consent form. Exclusion criteria included the following: ①Have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or patient is clinically unstable (eg, acute infections, electrolyte disturbances).②Patients with pacemaker implantation or metal implantation in the body. ③People with local skin at acupoints lesions, poor skin conditions, or other people unsuitable for PC-TEAS treatment. ④Cancer patients who are planning to become pregnant recently or are pregnant. ⑤Have a psychiatric disorder or severe cognitive impairment who are unable to communicate. ⑥Participating in other clinical trials.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06188286 · 0593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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