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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

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 21, 2014
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2014)
Satisfaction levels [ Time Frame: 6hrs following treatment ]
7-point Likert scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 18, 2014)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain
Official Title  ICMJE Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain With Radiculopathy
  • Low Back Pain Without Radiculopathy
  • Herniated Intervertebral Disc
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sinbaro-3
  • 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
    Intervention: Drug: Hwangryun
Publications * Not Provided

*   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: July 18, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 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 NCT02196129
Other Study ID Numbers  ICMJE JS-CT-2014-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In-Hyuk Ha, Jaseng Hospital of Korean Medicine
Study Sponsor  ICMJE Jaseng Hospital of Korean Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joonshik Shin Jaseng Hospital of Korean Medicine
PRS Account Jaseng Hospital of Korean Medicine
Verification Date November 2018

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