Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain
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ClinicalTrials.gov Identifier: NCT02196129 |
Recruitment Status :
Completed
First Posted : July 21, 2014
Last Update Posted : November 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain With Radiculopathy Low Back Pain Without Radiculopathy Herniated Intervertebral Disc | Drug: Sinbaro-3 Drug: Hwangryun | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial |
Actual Study Start Date : | July 2014 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | November 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Sinbaro-3
1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions
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Drug: Sinbaro-3
1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
Other Name: Harpagophytum Procumbens |
Placebo Comparator: Hwangryun(distillation)
1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention
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Drug: Hwangryun
1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain |
- Visual Analogue Scale [ Time Frame: At baseline ]The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
- Visual Analogue Scale [ Time Frame: 30 minutes following treatment ]The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
- Visual Analogue Scale [ Time Frame: 2 hours following treatment ]The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
- Visual Analogue Scale [ Time Frame: 4 hours following treatment ]The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
- Visual Analogue Scale [ Time Frame: 6 hours following treatment ]The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
- Satisfaction levels [ Time Frame: 6hrs following treatment ]7-point Likert scale
- Expected treatment effects [ Time Frame: At baseline ]The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients admitted to a Korean Medicine hospital for low back pain with or without radiculopathy
- Age between 18 and 69
- NRS score of >6 on the day of the intervention
- Voluntary participation with written consent given to study consent form
Exclusion Criteria:
- Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
- Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- Progressive neurologic deficit(s) or concurrent severe neurological symptoms
- Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
- Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
- Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
- During pregnancy or suspected pregnancy
- Subjects considered unsuitable for clinical trial by the researcher

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): NCT02196129
Korea, Republic of | |
Jaseng Hospital of Korean Medicine | |
Seoul, Gangnam-Gu, Korea, Republic of, 135-896 |
Principal Investigator: | Joonshik Shin | Jaseng Hospital of Korean Medicine |
Responsible Party: | In-Hyuk Ha, Dr, Jaseng Hospital of Korean Medicine |
ClinicalTrials.gov Identifier: | NCT02196129 |
Other Study ID Numbers: |
JS-CT-2014-02 |
First Posted: | July 21, 2014 Key Record Dates |
Last Update Posted: | November 7, 2018 |
Last Verified: | November 2018 |
low back pain pharmacoacupuncture sinbaro-3 |
Radiculopathy Back Pain Low Back Pain Pain |
Neurologic Manifestations Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |