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

Primary Purpose

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

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sinbaro-3

Hwangryun

About this trial

This is an interventional treatment trial for Low Back Pain With Radiculopathy focused on measuring low back pain, pharmacoacupuncture, sinbaro-3

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sinbaro-3

Hwangryun(distillation)

Arm Description

1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions

1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention

Outcomes

Primary Outcome Measures

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

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

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

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

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

Secondary Outcome Measures

Satisfaction levels

7-point Likert scale

Full Information

NCT ID

NCT02196129

First Posted

July 11, 2014

Last Updated

November 5, 2018

Sponsor

Jaseng Hospital of Korean Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02196129

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jaseng Hospital of Korean Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

low back pain, pharmacoacupuncture, sinbaro-3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sinbaro-3

Arm Type

Experimental

Arm Description

1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions

Arm Title

Hwangryun(distillation)

Arm Type

Placebo Comparator

Arm Description

1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention

Intervention Type

Drug

Intervention Name(s)

Sinbaro-3

Other Intervention Name(s)

Harpagophytum Procumbens

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hwangryun

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analogue Scale

Description

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

Time Frame

At baseline

Title

Visual Analogue Scale

Description

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

Time Frame

30 minutes following treatment

Title

Visual Analogue Scale

Description

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

Time Frame

2 hours following treatment

Title

Visual Analogue Scale

Description

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

Time Frame

4 hours following treatment

Title

Visual Analogue Scale

Description

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

Time Frame

6 hours following treatment

Secondary Outcome Measure Information:

Title

Satisfaction levels

Description

7-point Likert scale

Time Frame

6hrs following treatment

Other Pre-specified Outcome Measures:

Title

Expected treatment effects

Description

The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale

Time Frame

At baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joonshik Shin

Organizational Affiliation

Jaseng Hospital of Korean Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jaseng Hospital of Korean Medicine

City

Seoul

State/Province

Gangnam-Gu

ZIP/Postal Code

135-896

Country

Korea, Republic of

12. IPD Sharing Statement

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

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