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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
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, Jaseng Hospital of Korean Medicine

Brief Summary:
The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care

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

Detailed Description:
60 patients with LBP with moderate to severe pain(NRS>6) were randomly allocated to 2 groups. The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1 session, and comparisons of measurements were made before and after treatment. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before and after each measurement, the patients are asked to stand up and rotate their torso. At termination of the study, satisfaction levels of the patient's current status will also be collected.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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
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
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Satisfaction levels [ Time Frame: 6hrs following treatment ]
    7-point Likert scale


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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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
Criteria

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

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): NCT02196129


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 Hospital of Korean Medicine
Investigators
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Principal Investigator: Joonshik Shin Jaseng Hospital of Korean Medicine
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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
Keywords provided by In-Hyuk Ha, Jaseng Hospital of Korean Medicine:
low back pain
pharmacoacupuncture
sinbaro-3
Additional relevant MeSH terms:
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Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases