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

Jaseng Hospital of Korean Medicine

Status and phase: Completed; Phase 3

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

Treatments: Drug: Hwangryun; Drug: Sinbaro-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02196129

JS-CT-2014-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Sinbaro-3

Experimental group

Description:

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

Treatment:

Drug: Sinbaro-3

Hwangryun(distillation)

Placebo Comparator group

Description:

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

Treatment:

Drug: Hwangryun