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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study

Brief 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 Summary: 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.
Sponsor: Jaseng Medical Foundation

Current Primary Outcome: Visual analogue scale (VAS) of sciatic pain [ Time Frame: Week 5 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual analogue scale (VAS) of sciatic pain [ Time Frame: Week 1, 2, 3, 4, 7, 9, 12 ]
  • Visual analogue scale (VAS) of low back pain (LBP) [ Time Frame: Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  • Numeric rating scale (NRS) of low back pain (LBP) [ Time Frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  • Numeric rating scale (NRS) of sciatic pain [ Time Frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  • Oswestry Disability Index (ODI) [ Time Frame: Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  • Short Form Health Survey 36 (SF-36) [ Time Frame: Week 1, 5, 7, 12 ]
  • EuroQol-5 Dimension (EQ-5D) [ Time Frame: Week 1, 5, 7, 12 ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 1, 5, 7, 12 ]
  • Number and percentage of participants with adverse events [ Time Frame: Week 1, 2, 3, 4, 5, 7, 9, 12 ]
    The number and percentage of participants with adverse events, categorized by affected body region, will be reported.


Original Secondary Outcome: Same as current

Information By: Jaseng Medical Foundation

Dates:
Date Received: February 27, 2015
Date Started: September 9, 2015
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017