Effectiveness of Manual Acupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Pain severity with Visual Analog Scale
研究概览
简要总结
Cancer patients experience cancer pain as much as 66%. Cancer pain is pain that occurs in patients with neoplastic/malignancy and the source of the pain can come from malignant processes, treatments such as radiotherapy, chemotherapy, and surgery as well as other causes that are not related to malignancy processes. Unresolved pain can reduce the quality and life expectancy of cancer pain patients. The prevalence of cancer itself in Indonesia, the case of cervical cancer itself ranks second after breast cancer. In recent decades, acupuncture analgesics have been widely used to relieve cancer pain, and can also reduce the dose and side effects of analgesics. However, substantially the use of acupuncture in cancer pain is still very rare.
详细描述
The main outcome is to analyze the effectiveness of manual acupuncture therapy (LI4,PC6, LR3,ST36, and SP6 plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (QLQ C-30 EORTC score) in patients with gynecological cancer pain compared to standard therapy alone.
The patient will attempt 3-day manual acupuncture therapy with seven days follow up Patient will receive acupuncture therapy daily for 3 days, for 15 minute each day.
The research design in this study was a single-blinded randomized control clinical trial. With outcome measures for
With Subject criteria:
Inclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator blind the participant allocation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 to 65 years old
- •Gynecocal cancer with pain ≥ 4 acording Visual Analog scale and receive analgetic medicine
- •The pain cause by
- •direct from cancer
- •Treatment proces surgery, radiotherapy, chemotherapy, paliatif treatment, supportive treatment
- •Adverse reaction form treatment and intoxication
排除标准
- •emergency case patient with hemodynamic instable
- •patient with uncooperative behavior because ith serious psychological disorders, no currently undergoing psychiatric treatment, aggressive behavior, that not allowed for acupuncture.
- •Patients with blood clotting disorders, with platelets <50.000 and in neutropenic condition with <1000 neutrophils.
- •The patient has an allergy to stainless steel acupuncture needles. Wounds at the acupuncture point puncture sites, skin infections in the ears. On patients with eczema on the ears, external otitis or psoriasis.
- •There is a tumor in the area that will be stabbed and stimulated in the stomach pregnant women, close to the heart, or in the area of the carotid sinus lymphedema, insertion into the prosthesis.
- •Patients with heart rhythm disorders. The patient uses a pace maker.
结局指标
主要结局
Pain severity with Visual Analog Scale
时间窗: Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7
Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher scale means worse outcomes
次要结局
- Quality of Life with European Organisation for Research and Treatment of Cancer Quality of Life C30(before treatment and 7 day after treatment)
- Analgetic Usage in dosage and frequency(Before treatment, After treatment in day 1, day 2, day 3, day 5 and day 7)
研究者
Suryamin Suryamin
Medical Doctor
Indonesia University