The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
1 other identifier
observational
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 22, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 7, 2018
November 1, 2018
3 years
October 22, 2011
November 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
VAS of low back pain
Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
VAS of radiating leg pain
Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
Secondary Outcomes (3)
ODI (Oswestry Disability Index)
Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
SF-36 (Quality of Life)
Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
General assessment(patient/doctor)
16th week, 24th week
Study Arms (1)
integrative treatment
Interventions
120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for 16 weeks
A type of Korean spinal manual therapy administered 5\~10 minutes at physician's discretion once a week for 16 weeks. Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.
Acupuncture using sterilized disposable needles, sized 0.30X40 mm. Needles left for 15\~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, using a total of 10\~20 acupoints once a week for 16 weeks.
Bee-venom pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session once a week for 16 weeks.
Eligibility Criteria
Consecutive patient sampling within Failed Back Surgery Syndrome clinic
You may qualify if:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jaseng Hospital of Oriental Medicine
Bucheon-si, Gyeonggi Province, 420-814, South Korea
Jaseng Hospital of Oriental Medicine
Seoul, 135-896, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joonshik Shin, OMD, Ph.D
Jaseng Hospital of Korean Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2011
First Posted
October 5, 2012
Study Start
September 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
November 7, 2018
Record last verified: 2018-11