KCT0003615
Not yet recruiting
未知
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
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Seoul National University Hospital
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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