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

Phase 3CompletedNCT02196129

Jaseng Hospital of Korean Medicine60 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Low Back Pain With Radiculopathy Low Back Pain Without Radiculopathy Herniated Intervertebral Disc

Interventions

Sinbaro-3DRUG

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

HwangryunDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea