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

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ClinicalTrials.gov Identifier: NCT02384928
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, Jaseng Medical Foundation

Tracking Information
First Submitted Date  ICMJE February 27, 2015
First Posted Date  ICMJE March 10, 2015
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE September 9, 2015
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
Visual analogue scale (VAS) of sciatic pain [ Time Frame: Week 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sciatica
  • Intervertebral Disc Displacement
Intervention  ICMJE
  • Procedure: Shinbaro pharmacopuncture
    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.
  • Device: Acupuncture
    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.
  • Drug: Conventional medicine
    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).
    Other Name: Conventional drugs
  • Procedure: Physical therapy
    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.
    Other Name: Physiotherapy
  • Behavioral: Educational program
    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.
Study Arms  ICMJE
  • Experimental: Shinbaro pharmacopuncture group
    The 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.
    Interventions:
    • Procedure: Shinbaro pharmacopuncture
    • Device: Acupuncture
    • Behavioral: Educational program
  • Active Comparator: Acupuncture group
    The 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.
    Interventions:
    • Device: Acupuncture
    • Behavioral: Educational program
  • Active Comparator: Usual care group
    The 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:
    • Drug: Conventional medicine
    • Procedure: Physical therapy
    • Behavioral: Educational program
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 16, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02384928
Other Study ID Numbers  ICMJE JS-CT-2015-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party In-Hyuk Ha, KMD, Jaseng Medical Foundation
Study Sponsor  ICMJE Jaseng Medical Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinho Lee Jaseng Medical Foundation
PRS Account Jaseng Medical Foundation
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP