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

NCT02196129 | Completed Phase 3 DMC

• 1 other identifier: JS-CT-2014-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

low back pain; pharmacoacupuncture; sinbaro-3

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Satisfaction levels

  6hrs following treatment

Other Outcomes (1)

• Expected treatment effects

  At baseline

Study Arms (2)

Sinbaro-3

EXPERIMENTAL

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

Hwangryun(distillation)

PLACEBO COMPARATOR

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

Interventions

Sinbaro-3 DRUG

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

Also known as: Harpagophytum Procumbens

Sinbaro-3

Hwangryun DRUG

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(distillation)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Interventions

Harpagophytum extract LI 174

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Joonshik Shin

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (1)