Clinical trial NCT02196129: Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain
Official title: Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain With Radiculopathy
Low Back Pain Without Radiculopathy
Herniated Intervertebral Disc
Keywords: low back pain
pharmacoacupuncture
sinbaro-3
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: At baseline
measure: Visual Analogue Scale
timeFrame: 30 minutes following treatment
measure: Visual Analogue Scale
timeFrame: 2 hours following treatment
measure: Visual Analogue Scale
timeFrame: 4 hours following treatment
measure: Visual Analogue Scale
timeFrame: 6 hours following treatment
Secondary outcomes:
measure: Satisfaction levels
timeFrame: 6hrs following treatment
Other outcomes:
measure: Expected treatment effects
timeFrame: At baseline
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Joonshik Shin
role: PRINCIPAL_INVESTIGATOR
References: