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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain With Radiculopathy; Low Back Pain Without Radiculopathy; Herniated Intervertebral Disc
• Intervention / Treatment: Drug: Sinbaro-3; Drug: Hwangryun

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinbaro-3; 1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions	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; Other Names: Harpagophytum Procumbens
Placebo Comparator: Hwangryun(distillation); 1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction levels	7-point Likert scale	6hrs following treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 18, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; pharmacoacupuncture; sinbaro-3
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Low Back Pain; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: JS-CT-2014-02