Clinical trial NCT01701804: The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
Official title: The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome : A Multicenter, Prospective, Case Series Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Failed Back Surgery Syndrome
Keywords: Failed Back Surgery Syndrome
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patient sampling within Failed Back Surgery Syndrome clinic

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.

Detailed description: The purpose of this study is to investigate the effect of a non-surgical integrative package on failed back surgery syndrome through means of a prospective case series.

After initial screening, treatment will be administered one session a week for 16 weeks. Patients will be followed up at 4 and 8 weeks after conclusion of treatment.

The integrative package used in this study consists of 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) and dried extracts in pill form(Cibotium barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session), acupuncture and allow for NSAID intake during the investigational period. The subject is allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills taken will be measured at 4 wks after conclusion of treatment.

Eligibility 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

Primary outcomes:
measure: VAS of low back pain
timeFrame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
measure: VAS of radiating leg pain
timeFrame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
Secondary outcomes:
measure: ODI (Oswestry Disability Index)
timeFrame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
measure: SF-36 (Quality of Life)
timeFrame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
measure: General assessment(patient/doctor)
timeFrame: 16th week, 24th week
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Jaseng Hospital of Oriental Medicine
state: Gyeonggi Province
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Oriental Medicine
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Joonshik Shin, OMD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: