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

Herniated Intervertebral Disc Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196129
• Other study ID #: JS-CT-2014-02
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expected treatment effects	The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale	At baseline
Primary	Visual Analogue Scale	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	At baseline
Primary	Visual Analogue Scale	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	30 minutes following treatment
Primary	Visual Analogue Scale	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 hours following treatment
Primary	Visual Analogue Scale	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 hours following treatment
Primary	Visual Analogue Scale	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	6 hours following treatment
Secondary	Satisfaction levels	7-point Likert scale	6hrs following treatment