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Completed

NCT Number: NCT02196129

Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinbaro-3

Drug

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 names: Harpagophytum Procumbens

Hwangryun

Drug

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 outcomes

  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 outcomes

  1. Satisfaction levels

    Time frame: 6hrs following treatment

    7-point Likert scale

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Official study title

Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2014
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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