초록접수[미리보기]
| 21KF-047 |
Evaluation of an effectiveness and safety of the electroacupuncture in the management of intractable neuropathic pain
Jee Youn Moon, MD, PhDa, Chang-Soon Lee, MD, MSa, Yongjae Yoo, MD, PhDa, Suji Lee, KMD, MS, Sang Hoon Lee, KMD, PhD, Seunghoon Lee, KMD, PhD,
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital College of Medicine,
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University
Department of Acupuncture and Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital
A prospective, open-labeled, randomized, cross-over clinical trial
Background
There is no sufficient evidence on the effectiveness of acupuncture for neuropathic pain. This protocol describes a study that aims to evaluate the effectiveness and safety of electroacupuncture combined with conventional medicine for patients with intractable neuropathic pain, when compared with conventional medicine alone.
Inclusion criteria & Method
This study is a prospective, open-labeled, randomized, cross-over clinical trial. A total of 40 patients with neuropathic pain who had a numeric rating scale (NRS) score of over 4 despite receiving conventional treatment for more than 3 months will be enrolled. Participants will receive conventional treatment for neuropathic pain (treatment C) or treatment C combined with 12 additional sessions of electroacupuncture treatment (treatment A) for 6 weeks. Participants will be randomly assigned to 1 of the 2 sequence groups (AC and CA group) with a 1:1 allocation. The differences of responder in the composite efficacy outcomes, which consist of the NRS, Brief Pain Inventory-Short Form (BPI-SF) pain subscale, and global assessment at 6 weeks after randomization will be examined as the primary outcome. Secondary outcomes include differences in the NRS, the Short-Form McGill Pain Questionnaire, BPI-SF, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Medical Outcomes Study Sleep Scale, global assessment, EQ-5D, and incremental cost-effective ratio at 6 and 15 weeks after randomization. Adverse events, vital signs, and physical examinations will be recorded to evaluate safety.
Disccusion
The study protocol for this trial will provide up-to-date evidence on the effectiveness and safety of electroacupuncture for patients with intractable neuropathic pain. The results will be disseminated through a peer-reviewed journal and conference presentations.
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