Overview

The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the effect of a non-surgical integrative package consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture, acupuncture on failed back surgery syndrome through means of a prospective case series.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jaseng Hospital of Korean Medicine
Criteria
Inclusion Criteria:

- Patients suffering from low back pain and/or leg pain that does not improve or the
return of the symptoms within 1 year of spinal surgery

- Low back pain and/or leg pain with duration at least 3 weeks at baseline

- Low back pain and/or leg pain at least 60mm on VAS scale

- Age between 18 and 60

- Given consent to lumbar MRI

- Voluntary participation with written consent given to study consent form

- Given consent to not receive other treatment concerning pain due to spinal disorders
during study participation period

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