Rehabilitation of Breast Cancer Treatment Related Lymphedema Using Electro-acupuncture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in amount of arm tissue water determined by Bioimpedance Analysis
研究概览
简要总结
This study is being conducted to determine if electro-acupuncture can reduce swelling of the arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted on animals suggests that such treatment might be used to improve circulation leading to reductions in swelling. Previous research in humans with lymphedema suggests that treatment may be safe to use, although results regarding its efficacy in the reduction of swelling have not yet been established.
This research will use sophisticated, non-invasive assessment methods to determine if a single session of electro-acupuncture treatment can be effective for reducing lymphedema. Results may be used to further develop our understanding of how electro-acupuncture can be used in the management of this condition. Electro-acupuncture may provide a promising complement or alternative to conventional lymphedema treatments such as compression bandaging, massage therapy or surgery.
详细描述
Participants will be invited to attend a 30-60 minute screening visit to determine eligibility. This screening visit will be located at a laboratory at McMaster University's Institute of Applied Health Sciences. Eligibility will be determined using health questionnaires and non-invasive physical assessment of the upper limbs. Participants may not be eligible for further participation based on their health status and risks to health and safety.
Participants meeting eligibility criteria will be invited to 1 scheduled appointment (30-60 minutes in duration). The appointment time will be scheduled according to individual symptoms, such that it will coincide with the time of day that lymphedema symptoms are predicted to be at their highest. Upon arrival at the scheduled appointment, participants will be randomized to receive 20 minutes of acupuncture+applied electrical stimulation or no treatment. Participants in both groups will be asked to provide physical assessment data over a period of 30 minutes during the scheduled appointment. Differences between groups in tissue swelling of the affected upper-limb will be determined immediately following treatment, and at 10 minutes following treatment.
Participants will be asked to report any significant changes to their health state for a period of 2 weeks following treatment. A follow-up questionnaire will be made available at 2 weeks following attendance of the scheduled appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>1yr following the conclusion of breast cancer treatment
- •Lymphedema of the upper limb: unilateral (one-side)
排除标准
- •History or evidence of hormone-receptor positive cancer
- •Previous nodal dissection or radiotherapy to other regions
- •Contraindications for acupuncture or electrical stimulation
- •Pre-cancer or bi-lateral lymphedema
- •Evidence of active cancer
- •History of contralateral cancer, radiation or surgery
- •Edema of the neck/midline/torso
- •Pregnancy
- •Allergies to nickel, chromium, or silicon
- •Seizures (epilepsy)
- •Tremors (shakiness) that may interfere with treatment
- •Infections, scarring, open wounds, or broken skin at needle sites
- •Infections, open wounds, or broken skin on the upper limbs (electrode & landmark sites)
研究组 & 干预措施
Acupuncture + Electrical Stimulation
Acupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes.
干预措施: Acupuncture + Electrical Stimulation (Device)
Control
Participants who are randomized to receive no intervention will still receive physical assessment.
结局指标
主要结局
Change in amount of arm tissue water determined by Bioimpedance Analysis
时间窗: Before and after a 20 minute period at a single scheduled appointment
Bioimpedance analysis devices take readings using 8 electrode pads that are placed on top of the skin of the arms. The electrode pads are connected to a computer that transmits a small amount of electrical current between the electrode pads. The process of taking readings takes less than 1 minute and is painless (participants may not be able to feel it working).
次要结局
- Change in dermal concentration of red blood cells in the arm assessed using light polarization spectroscopy(Repeated measures during a single scheduled appointment - once every 2 minutes for 44 minutes)
- Change in arm circumference(Before and after a 20 minute period at a single scheduled appointment)
- Lymphedema Questionnaire(Administered at a single screening visit and 2 week follow up)