"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
研究概览
简要总结
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior
详细描述
A double blind prospective randomized controlled pilot study with cross over.
To assess the effectiveness of EA in improving pain and function for chronic chemotherapy Induced Peripheral Neuropathy (CIPN) 30 participants will be recruited 6 months post-completion of chemotherapy. Fifteen participants will be randomized to the true EA group and 15 to the sham EA group. Those participants randomized to the sham group will cross over to receive true EA after the trial is complete.
Treatment consists of EA or sham EA 1 x per week x 6 weeks. Re-assessment visits occur after the 6 week intervention and again 2 months post trial.
Each assessment visit quantifies the sensory experience of CIPN at that moment in time using Quantitative Sensory Testing (QST) which includes; thermal detection and thermal pain thresholds, light touch detection using nylon monofilament hairs (Semmes Weinstein Monofilaments (SWMF)), static 2-point discrimination, pressure algometry and vibration thresholds. Patient reported outcome measures including the Disabilities of the Arm, Shoulder and Hand (DASH), Lower extremity functional score (LEFS), the Self report Leeds Assessment of Neuropathic signs and symptoms (S-LANSS) pain questionaire will also be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient diagnosed with stage 1-3 breast cancer who has finished chemotherapy 6 months prior and has residual CIPN symptoms graded as a 3/10 or higher on the numeric rating pain scale.
排除标准
- •Patients who have co-morbid conditions that cause peripheral neuropathic symptoms
- •patients with heart valve replacements
- •patients on prophylactic antibiotics
- •patients with severe coagulopathy
- •patients who did not receive regular taxane therapy
研究组 & 干预措施
Acupuncture
Acupuncture will consist of acupuncture points ST36, LR3, LI4 bilaterally x 30 minutes, once a week over 6 weeks. ST36 will have EA with 2Hz at the maximum tolerated intensity (ES-130 Portable Japanese Electro-Acupuncture Device, UPC Medical Supplies Inc. South El Monte, CA, USA).
干预措施: Acupuncture (Device)
Sham Acupuncture
Sham acupuncture (Streitberger Placebo Needles, Asiamed) uses the same points and treatment parameters but the placebo needle does not penetrate the skin and the current for EA is not turned on.
干预措施: Sham Acupuncture (Device)
结局指标
主要结局
S-Lanss (short- Leads assessment of neuropathic symptoms and signs)
时间窗: 2 years
16 point pain questionnaire that differentiates nociceptive from neuropathic pain
VAS (Visual Analogue Scale)
时间窗: 2 years
10 point verbal rating pain scale to measure participants pain in each assessment
LEFS (Lower extremity functional scale)
时间窗: 2 years
20 item questionnaire measuring lower limb function
DASH (Disabilities of the arm, shoulder, hand)
时间窗: 2 years
30 item questionnaire measuring upper limb function
次要结局
未报告次要终点
研究者
Barbara Shay
Associate Professor, Department head, College of Rehabilitation Sciences
University of Manitoba