Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedStudy Start
First participant enrolled
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2017
CompletedJuly 26, 2022
July 1, 2022
1.4 years
February 27, 2015
July 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analogue scale (VAS) of sciatic pain
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Week 5
Secondary Outcomes (9)
Visual analogue scale (VAS) of sciatic pain
Week 1, 2, 3, 4, 7, 9, 12
Visual analogue scale (VAS) of low back pain (LBP)
Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of low back pain (LBP)
Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of sciatic pain
Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Oswestry Disability Index (ODI)
Week 1, 2, 3, 4, 5, 7, 9, 12
- +4 more secondary outcomes
Study Arms (3)
Shinbaro pharmacopuncture group
EXPERIMENTALThe Shinbaro pharmacopuncture group will receive 8 interventional sessions of Shinbaro pharmacopuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week.
Acupuncture group
ACTIVE COMPARATORThe acupuncture group will receive 8 interventional sessions of acupuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and 5 other acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week.
Usual care group
ACTIVE COMPARATORThe usual care group will receive conventional medicine 2 times/day and 2 sessions/week of physical therapy over 4 weeks. 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, which include aceclofenac, tramadol hydrochloride, talniflumate, diclofenac sodium, and loxoprofen sodium. All groups will take 4 educational program sessions supervised by physicians once a week.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896, South Korea
Related Publications (1)
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.
PMID: 26459006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinho Lee
Jaseng Medical Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 10, 2015
Study Start
September 9, 2015
Primary Completion
January 31, 2017
Study Completion
March 16, 2017
Last Updated
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share