Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients - A Randomized, Double-blind, Placebo-controlled Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of mean pain intensity last 24 hours
研究概览
简要总结
Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and thus, pain control plays a central role in palliative care.
Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for patients who experience suboptimal pain control. However, the evidence for the efficacy of TENS in cancer patients is not unambiguous.
The present study is a double blind, placebo-controlled cross-over trial with a short-term follow-up.
The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain reduction in advanced cancer patients.
The secondary aim is the explorative identification of subgroups that benefit or do not benefit from TENS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point NRS the last 24 hours
- •Age: ≥ 18 years
- •Patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service
排除标准
- •Verbal or cognitive inability to use TENS or to answer the questionnaire
- •High probability of dying within the next week
- •Pain that is not directly or indirectly related to tumor
- •Contraindications: Jones (2009) & Disselhoff (2012)
- •electronic implants like pacemakers
- •Metal implant on electrode site
- •Arrhythmia
- •Pregnancy
- •Dermatological conditions or frail skin on electrode site
- •Anamnestically known distinct allergy regarding electrodes
- •Drop-out criteria after inclusion:
- •Patients that decide to stop TENS treatment (at any time or any reason).
- •Further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.
研究组 & 干预措施
Modulated TENS
干预措施: Modulated TENS (Device)
Placebo TENS
干预措施: Placebo TENS (Device)
结局指标
主要结局
Change of mean pain intensity last 24 hours
时间窗: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point Numerical Rating Scale (NRS): 0-10; 0=no pain; 10=pain as bad as you can imagine
次要结局
- Mood(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Change of worst pain intensity last 24 hours(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- General Activity(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Change of least pain intensity last 24 hours(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Change of pain perception during TENS application on NRS(After the 24-hour-interventions and after the follow-up: at an average of one week)
- Change of pain perception during TENS application on VRS(After the 24-hour-interventions and after the follow-up: at an average of one week)
- Number and percent of responders(After the 24-hour-interventions and after the follow-up: at an average of one week)
- Quality of life last 24 hours(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Walking ability(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Normal Work (includes both work outside the home and housework)(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Relations with other people(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Sleep(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
- Enjoyment of life(Before and after the 24-hour-interventions and after the follow-up: at an average of one week)
研究者
Waldemar Siemens
MSc
University Hospital Freiburg