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

• Status: Completed
• Trial end date: 2017-03-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaseng Medical Foundation
• Treatments: Tramadol

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)