Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain : A prospective, open-labeled, randomized, cross-over clinical trial

Seoul National University Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新: 2019年3月25日

适应症

试验速览

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•1. Patients aged 19 years and over at screening
•2. Patients who could voluntarily consent to the study, understand the process of the study, and adequately write a reportable questionnaire.
•3. Patients who have peripheral neuropathic pain satisfied A and B, and identified C or D depending on the conditions.
•A. Having a confirmed medical history according to clinical findings (e.g., postherpetic neuralgia, chemotherapy induced peripheral neuropathy).
•B. Symptoms, history, and physical examination of patients are appropriate for peripheral neuropathic pain
•C. electromyography (EMG)/nerve conduction study (NCS) or evoked potential test is appropriate for peripheral neuropathy.
•D. Ultrasonographic examination at the screening revealed lesions that are appropriate for peripheral entrapment syndrome or peripheral neuropathy
•4. Unsatisfactory pain relief despite of appropriate conservative treatment for more than 3 months before screening
•5. A score = 13 on the Korean version of the painDETECT Qusestionnaire (PD-Q) at screening
•6. An average socre = 4 on the Numeral Rating Scale measured by pain diary during the one-week screening period before randomization.
•7. No evidence of disease (NED) recurrence in cancer survivors

•1. Other severe pain not related to the target disease induce confusion in pain assessment at screening or randomization.
•2.Use of a prohibited concomitant therapy within 7 days prior to screening or a changed concomitant medication with restricted usage change within 14 days prior to screening.
•3. Clinically significant unstable nervous system, ophthalmology, hepatobiliary, respiratory, blood disease, cardiovascular disease, or mental disease within 12 months before screening.
•4. Use of electrocaupuncture treatment at the affected area within 1 month before screening.
•5. Pregnant, breastfeeding, or expecting a pregnancy during the study period.
•6. Implanted medical devices such as spinal cord stimulators, implantable drug delivery systems, pacemakers, automatic defibrillators, aneurysm clips, vena cava clips, and skull plates.
•7. Brain damage, symptomatic brain metastases, or epilepsy.
•8. Abnormal skin conditions that would prevent proper application of the EA treatment.
•9. Participation in other interventional clinical trials within 30 days before screening or present.
•10. Severe bleeding tendency: low doses of oral aspirin and a general dose of antiplatelet/anticoagulant medication generally do not limit study participation, but only when apparent risk is predicted by the investigator's judgment.
•11. Using immunosuppressive drugs such as steroids.

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