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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Jaseng Hospital of Korean Medicine

Current Primary Outcome:

  • 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 ]
  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ODI (Oswestry Disability Index) [ Time Frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week ]
  • SF-36 (Quality of Life) [ Time Frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week ]
  • General assessment(patient/doctor) [ Time Frame: 16th week, 24th week ]
    General assessment of improvement by doctor and patient


Original Secondary Outcome: Same as current

Information By: Jaseng Hospital of Korean Medicine

Dates:
Date Received: October 22, 2011
Date Started: September 2011
Date Completion:
Last Updated: September 24, 2014
Last Verified: September 2014