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临床试验/NCT05052645
NCT05052645撤回不适用

Auricular Acupuncture in the Treatment of Neuropathic Pain: A Randomized Controlled Trial

Mayo Clinic2 个研究点 分布在 1 个国家开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
试验地点
2
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

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.

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

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tony Y. Chon

Principal Investigator

Mayo Clinic

研究点 (2)

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