Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Change in self-reported neuropathic pain scores
研究概览
简要总结
The purpose of this study is to gather information on the effectiveness of auricular acupuncture (i.e., the placement of acupuncture needles in specific points on the ear) in reducing pain and improving quality of life among patients experiencing neuropathic pain in the acute inpatient rehabilitation setting.
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
- None
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 who have acute or chronic neuropathic pain of any etiology (traumatic, non-traumatic, central, peripheral, and mixed cases).
- •Ability to provide informed consent.
- •Ability to speak English and complete all aspects of this trial.
- •At least 18 years of age.
- •Patients will have stable neuropathic pain medication dosing for 3 days prior to enrollment to include gabapentin, pre-gabalin, TCAs, duloxetine, carbamazepine, oxcarbazepine, and venlafaxine).
排除标准
- •Patients with platelet count <50,000 or known bleeding disorder.
- •Patients in a severe immunocompromised state.
- •Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.
- •Allergy to gold.
- •Use of non-FDA approved herbal supplements. Their effect on enhancing or blunting effect of acupuncture is not known. Patients using medical marijuana with an approved prescription from a state issuing such prescriptions will not be excluded.
- •Current infection of the skin or cartilage of the ear.
- •Patients already using adjuvant modalities such as chiropractic, massage, yoga, tai chi, massage will not be excluded, but those who add in these modalities during the course of the intervention and observation period will be excluded.
- •Patients not anticipated to stay for a minimum of 7 days after enrollment.
- •Patient without mental capacity to participate in the consent process and the questionnaire responses.
- •Fear of needles or no interest in acupuncture.
研究组 & 干预措施
Standard of Care Group
Subjects will receive standard of care neuropathic pain treatment without acupuncture.
Acupuncture Treatment Group
Subjects will receive acupuncture treatment in addition to to the standard of care neuropathic pain treatment.
干预措施: Auricular acupuncture (Procedure)
结局指标
主要结局
Change in self-reported neuropathic pain scores
时间窗: Daily during inpatient stay, approximately 7-10 days
Measured on the numeric rating scale for pain (NRS Pain) for pain intensity using a scale of 0=no pain, 10=worst imaginable
次要结局
未报告次要终点