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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

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.

Condition or disease Intervention/treatment Phase
Sciatica Intervertebral Disc Displacement Procedure: Shinbaro pharmacopuncture Device: Acupuncture Drug: Conventional medicine Procedure: Physical therapy Behavioral: Educational program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : March 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Hernia

Arm Intervention/treatment
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.
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.

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.

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.
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.

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.

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.
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.




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

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) of sciatic pain [ Time Frame: Week 1, 2, 3, 4, 7, 9, 12 ]
  2. Visual analogue scale (VAS) of low back pain (LBP) [ Time Frame: Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  3. Numeric rating scale (NRS) of low back pain (LBP) [ Time Frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  4. Numeric rating scale (NRS) of sciatic pain [ Time Frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  5. Oswestry Disability Index (ODI) [ Time Frame: Week 1, 2, 3, 4, 5, 7, 9, 12 ]
  6. Short Form Health Survey 36 (SF-36) [ Time Frame: Week 1, 5, 7, 12 ]
  7. EuroQol-5 Dimension (EQ-5D) [ Time Frame: Week 1, 5, 7, 12 ]
  8. Patient Global Impression of Change (PGIC) [ Time Frame: Week 1, 5, 7, 12 ]
  9. 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.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384928


Locations
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Korea, Republic of
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, Korea, Republic of, 135-896
Sponsors and Collaborators
Jaseng Medical Foundation
Investigators
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Principal Investigator: Jinho Lee Jaseng Medical Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT02384928    
Other Study ID Numbers: JS-CT-2015-03
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
Acupuncture
Pharmacopuncture
Usual Care
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Sciatica
Hernia
Pathological Conditions, Anatomical
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases