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
  Purpose

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.


Condition Intervention
Failed Back Surgery Syndrome
Drug: Chuna herbal medicine
Procedure: Chuna manual therapy
Procedure: Acupuncture
Procedure: Bee-venom pharmacoacupuncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome : A Multicenter, Prospective, Case Series Observational Study

Resource links provided by NLM:


Further study details as provided by Jaseng Hospital of Korean Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
integrative treatment 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

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patient sampling within Failed Back Surgery Syndrome clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701804

Contacts
Contact: Inhyuk Ha, OMD +82-10-6659-4910 hanihata@hanmail.net
Contact: SANG EUN PARK, phd +82-10-4804-6437 eun6437@hanmail.net

Locations
Korea, Republic of
Jaseng Hospital of Oriental Medicine Recruiting
Bucheon, Gyeonggi Province, Korea, Republic of, 420-814
Contact: Charo Lee, OMD    +82-10-6220-6574    withiscar@jaseng.co.kr   
Principal Investigator: Charo Lee, OMD         
Jaseng Hospital of Oriental Medicine Recruiting
Seoul, Korea, Republic of, 135-896
Contact: Inhyuk Ha, OMD    +82-10-6659-4910    hanihata@hanmail.net   
Contact: Me-riong Kim, OMD    +82-10-9500-0930    theodorian@naver.com   
Sub-Investigator: Inhyuk Ha, OMD         
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
Principal Investigator: Joonshik Shin, OMD, Ph.D Jaseng Hospital of Korean Medicine
  More Information

No publications provided

Responsible Party: Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT01701804     History of Changes
Other Study ID Numbers: JS-CT-2011-2
Study First Received: October 22, 2011
Last Updated: July 11, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Jaseng Hospital of Korean Medicine:
Failed Back Surgery Syndrome

Additional relevant MeSH terms:
Failed Back Surgery Syndrome
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014