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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Jaseng Hospital of Korean Medicine
Sponsor:
Information provided by (Responsible Party):
Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier:
NCT01701804
First received: October 22, 2011
Last updated: July 11, 2014
Last verified: July 2014

October 22, 2011
July 11, 2014
September 2011
September 2014   (final data collection date for primary outcome measure)
  • VAS of low back pain [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week ] [ Designated as safety issue: No ]
  • VAS of radiating leg pain [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01701804 on ClinicalTrials.gov Archive Site
  • ODI (Oswestry Disability Index) [ Time Frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week ] [ Designated as safety issue: No ]
  • SF-36 (Quality of Life) [ Time Frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week ] [ Designated as safety issue: No ]
  • General assessment(patient/doctor) [ Time Frame: 16th week, 24th week ] [ Designated as safety issue: No ]
    General assessment of improvement by doctor and patient
Same as current
Not Provided
Not Provided
 
The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome : A Multicenter, Prospective, Case Series Observational Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Consecutive patient sampling within Failed Back Surgery Syndrome clinic

Failed Back Surgery Syndrome
  • Drug: Chuna herbal medicine
    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
  • Procedure: Chuna manual therapy
    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.
    Other Name: Chuna manipulation
  • Procedure: Acupuncture
    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.
  • Procedure: Bee-venom pharmacoacupuncture
    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.
    Other Names:
    • BV
    • Bee-venom therapy
integrative treatment
Interventions:
  • Drug: Chuna herbal medicine
  • Procedure: Chuna manual therapy
  • Procedure: Acupuncture
  • Procedure: Bee-venom pharmacoacupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
May 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
No
Contact: Inhyuk Ha, OMD +82-10-6659-4910 hanihata@hanmail.net
Contact: SANG EUN PARK, phd +82-10-4804-6437 eun6437@hanmail.net
Korea, Republic of
 
NCT01701804
JS-CT-2011-2
Not Provided
Jaseng Hospital of Korean Medicine
Jaseng Hospital of Korean Medicine
Not Provided
Principal Investigator: Joonshik Shin, OMD, Ph.D Jaseng Hospital of Korean Medicine
Jaseng Hospital of Korean Medicine
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP