The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Observational

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.
    

Intervention name(s): Chuna herbal medicine; Chuna manual therapy; Acupuncture; Bee-venom pharmacoacupuncture
Intervention type(s): Drug; Procedure; Procedure; Procedure
Intervention description(s): 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.
Other intervention name(s): Chuna manipulation; BV; Bee-venom therapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patient sampling within Failed Back Surgery Syndrome clinic
      
Keywords: Failed Back Surgery Syndrome