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

Failed Back Surgery Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701804
• Other study ID #: JS-CT-2011-2
• Status: Completed
• Start date: September 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Oriental Medicine	Bucheon	Gyeonggi Province
Korea, Republic of	Jaseng Hospital of Oriental Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS of low back pain		Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
Primary	VAS of radiating leg pain		Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
Secondary	ODI (Oswestry Disability Index)		Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
Secondary	SF-36 (Quality of Life)		Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
Secondary	General assessment(patient/doctor)	General assessment of improvement by doctor and patient	16th week, 24th week