Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation

Overview

This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.

This study is a three-armed, randomized, patient, physician, and assessor-blinded, controlled pilot to the aim of evaluating the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, onset between 4 weeks and 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture+acupuncture), acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.