The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
NCT ID: NCT01701804
Last Updated: 2018-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2011-09-30
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Evaluation of the Effectiveness of CAM Treatments for Lumbar and Cervical Spine Pain Patients Due to Spinal Disease
NCT01791933
The Effect of Integrated CAM Treatment in Hospitalized Patients
NCT02257723
Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis
NCT03879447
Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
NCT03858556
The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain
NCT06591221
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
integrative treatment
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jaseng Hospital of Korean Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joonshik Shin, OMD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Jaseng Hospital of Korean Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jaseng Hospital of Oriental Medicine
Bucheon-si, Gyeonggi Province, South Korea
Jaseng Hospital of Oriental Medicine
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JS-CT-2011-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.