effects of shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation

Conditions: Sciatica; Intervertebral Disc Displacement

Summary: 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.

Eligibility criteria:
inclusion criteria: * sciatica patients with an average sciatic pain nrs of 5 or higher during the preceding 3 days * onset of at least 4 weeks previous for current sciatic pain episode * patients whose sciatic symptoms correlate with the ldh confirmed on mri * patients who have agreed to follow the trial protocol exclusion criteria: * patients who have received invasive treatments such as nerve blocks, pharmacopuncture, or acupuncture within the past week * non-spinal or soft tissue pathologies which may cause lbp or sciatic pain (e.g. spinal tumors, rheumatic arthritis) * pregnancy * history of spinal surgery, or spinal pathologies other than ldh (e.g. spinal dislocation, fracture) * severe progressive neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness) * patients for whom acupuncture may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine, severe diabetes with risk of infection, severe cardiovascular diseases or other conditions deemed unsuitable)

Keywords: acupuncture pharmacopuncture usual care