- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02384928
Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
July 22, 2022 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation
Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
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.
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gangnam-Gu
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Seoul, Gangnam-Gu, Korea, Republic of, 135-896
- Jaseng Hospital of Korean Medicine
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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.
|
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.
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.
|
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.
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.
|
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.
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS) of sciatic pain
Time Frame: Week 5
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (VAS) of sciatic pain
Time Frame: Week 1, 2, 3, 4, 7, 9, 12
|
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
|
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
|
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
|
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
|
The patient choose number between 0 to 10, which represent the serverity of the pain that he felt.
0 means there's no pain, and 10 means there's severe pain that he ever felt.
|
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
|
The patient choose number between 0 to 10, which represent the serverity of the pain that he felt.
0 means there's no pain, and 10 means there's severe pain that he ever felt.
|
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
|
The Oswestry Disability Index (ODI) is an index is derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
The ODI is a 10-item score from 0 to 100 that encompasses limitations in activity, sleeping, social life, work, and personal care resulting from low back pain.
|
Week 1, 2, 3, 4, 5, 7, 9, 12
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Short Form Health Survey 36 (SF-36)
Time Frame: Week 1, 5, 7, 12
|
SF-36 Questionnaire consists of several questions related to local pain, radiationg pain, analgesic intake and ability.
|
Week 1, 5, 7, 12
|
EuroQol-5 Dimension (EQ-5D)
Time Frame: Week 1, 5, 7, 12
|
Estimates that shows the quality of life(QOL).
|
Week 1, 5, 7, 12
|
Patient Global Impression of Change (PGIC)
Time Frame: Week 1, 5, 7, 12
|
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.
|
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.
|
Week 1, 2, 3, 4, 5, 7, 9, 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinho Lee, Jaseng Medical Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 9, 2015
Primary Completion (ACTUAL)
January 31, 2017
Study Completion (ACTUAL)
March 16, 2017
Study Registration Dates
First Submitted
February 27, 2015
First Submitted That Met QC Criteria
March 4, 2015
First Posted (ESTIMATE)
March 10, 2015
Study Record Updates
Last Update Posted (ACTUAL)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2015-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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