Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
Condition: Sciatica; Intervertebral Disc Displacement
MeSH terms: Intervertebral Disc Displacement; Sciatica
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Shinbaro pharmacopuncture; Acupuncture; Conventional medicine; Physical therapy; Educational program
Intervention type(s): Procedure; Device; Drug; Procedure; Behavioral
Intervention description(s): Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints. One Hyeopcheok (Huatuo Jiaji, EX B2) acupoint most relevant to patient symptoms with reference to MRI will be administered Shinbaro pharmacopuncture.; Five acupoints will be needled to about 1cm depth assisted by an acupuncture guide tube with no manual stimulation such as twirling or lifting and thrusting.; Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. The most frequently prescribed conventional drugs for LDH include aceclofenac (Drug class: nonsteroidal antiinflammatoy drugs (NSAIDs)), tramadol hydrochloride (Drug class: Opioids), talniflumate (Drug class: NSAIDs), diclofenac sodium (Drug class: NSAIDs), and loxoprofen sodium (Drug class: NSAIDs).; Physical therapy will be prescribed with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics.; Educational program sessions supervised by physicians will be provided once a week for 4 weeks.The education program will inform the patient of the favorable prognosis of LDH, and instructions for everyday activities and self-management. The education program will consist of handbooks handed out to each participant, and weekly reminders and encouragement from the physician.
Other intervention name(s): Conventional drugs; Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Pharmacopuncture; Usual Care