Auricular Acupuncture: A Novel Application in Ureteral Stent Pain.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- improved ability to tolerate the presence of the ureteral stent
研究概览
简要总结
The investigators propose to complete a randomized controlled trial to compare battlefield auricular acupuncture at five points in right ear and five points in left ear (cingulate gyrus, thalamus, omega 2, point zero, and shen men) plus standard of care, versus standard of care alone, for symptomatic treatment of stent pain in postoperative ureteral stent patients. Male and female DoD beneficiaries ages 18 years or older, who are scheduled for elective urologic surgery that would be expected to have the routine placement of a ureteral stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, ESWL of stone greater than 10mm) will be recruited. Subjects will be followed up at 24 hours post surgery, 48 hours, 1 week, 1 month, and 1 month post surgery. The investigators will ask subjects to rate their pain level on a 0-10 analogue scale, the investigators will assess via the Ureteric Stent Symptoms Questionnaire (USSQ) subjects' urinary urgency, urinary frequency, and quality of life. The investigators will ask subjects how many pills they have taken for their pain including the quantity and dose to assess a reduction in pain medication use.
详细描述
Subjects will be ages 18 years or older and scheduled for routine urologic surgery. To randomize subjects, the investigators will employ a random number generator, which will minimize difference between study groups.
Screening Visit:
Obtain signed Informed Consent document and HIPAA Authorization. Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, prior surgical history, demographics, problems list, and note any prior acupuncture received.
Subjects will be given a Medication Log to assist them in documenting the amount of pain medications that they are taking as part of standard of care.
Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
- •Male and female DoD beneficiaries
- •Age 18 years or older who are scheduled for elective urologic surgery that would be expected to have the routine placement of a ureteral stent (ureteroscopy, ureteroscopy with biopsy, ureteroscopy with laser treatment of a stone, extracorporeal stone wave lithotripsy (ESWL) of stone greater than 10mm).
排除标准
- •Pregnant or breastfeeding.
- •Traumatic ureteral injury repairs with stents.
- •Ureteral stents placed during procedures for urologic cancer treatments.
- •Sepsis prior to stent placement or other active urologic infection.
- •Absence of ear.
- •Active cellulitis of ear.
- •Ear anatomy precluding identification of acupuncture landmarks.
- •Non-English speaking.
- •Use of Hearing Aids that preclude the insertion of ASP needles.
- •Inability to comply with study protocol.
- •Patients receiving treatment for chronic pain conditions.
结局指标
主要结局
improved ability to tolerate the presence of the ureteral stent
时间窗: 1 month
This will be assessed via the Ureteric Stent Symptoms Questionnaire
次要结局
- reduce narcotic use(1 month)
- post-operative readmission rates for pain/irritative symptoms(1 month)