Clinical trial NCT02384928: Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
Official title: Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica
Intervertebral Disc Displacement
Keywords: Acupuncture
Pharmacopuncture
Usual Care
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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)

Primary outcomes:
measure: Visual analogue scale (VAS) of sciatic pain
timeFrame: Week 5
Secondary outcomes:
measure: Visual analogue scale (VAS) of sciatic pain
timeFrame: Week 1, 2, 3, 4, 7, 9, 12
measure: Visual analogue scale (VAS) of low back pain (LBP)
timeFrame: Week 1, 2, 3, 4, 5, 7, 9, 12
measure: Numeric rating scale (NRS) of low back pain (LBP)
timeFrame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
measure: Numeric rating scale (NRS) of sciatic pain
timeFrame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
measure: Oswestry Disability Index (ODI)
timeFrame: Week 1, 2, 3, 4, 5, 7, 9, 12
measure: Short Form Health Survey 36 (SF-36)
timeFrame: Week 1, 5, 7, 12
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: Week 1, 5, 7, 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 1, 5, 7, 12
measure: Number and percentage of participants with adverse events
timeFrame: Week 1, 2, 3, 4, 5, 7, 9, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Medical Foundation
name: Jinho Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Shin JS, Lee YJ, Kim MR, Ahn YJ, Park KB, Kropf MA, Shin BC, Lee MS, Ha IH. Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:455. doi: 10.1186/s13063-015-0993-6.