Herniated Intervertebral Disc, Low Back Pain Without Radiculopathy, Low Back Pain With Radiculopathy
Conditions
Keywords
low back pain, pharmacoacupuncture, sinbaro-3
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.
Interventions
DRUGSinbaro-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
DRUGHwangryun
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
Sponsors
Jaseng Hospital of Korean Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction levels | 6hrs following treatment | 7-point Likert scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Expected treatment effects | At baseline | The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale |
Countries
South Korea
Outcome results
None listed