Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica
November 6, 2018 updated by: Jinho Lee, Jaseng Medical Foundation
Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study
A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life
Study Overview
Status
Terminated
Conditions
Detailed Description
This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Jaseng Medical Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations of Jaseng Hospital of Korean Medicine between November 2016 and March 2018
Description
Inclusion Criteria:
- Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4)
- Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI
- Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)
- Patients who have received surgery recommendation for lumbar spinal stenosis
- Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 months
- Patients who have agreed to study participation
Exclusion Criteria:
- Patients with vascular claudication
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)
- Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
- Pregnant patients or patients planning pregnancy
- Patients with serious psychological disorders
- Patients unable to fill out study participation consent form
- Subjects deemed unsuitable for study participation as assessed by the researchers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
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Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test.
Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion.
Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Other Names:
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Other Names:
Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Other Names:
Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Numeric rating scale (NRS) of low back pain
Time Frame: Change from baseline to 3 months
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Change in low back pain intensity
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Change from baseline to 3 months
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Change in Numeric rating scale (NRS) of radiating leg pain
Time Frame: Change from baseline to 3 months
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Change in radiating leg pain intensity
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Change from baseline to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric rating scale (NRS) of low back pain
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Low back pain intensity for the past 3 days
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Baseline, 1, 2, 3, 6, 12 months
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Numeric rating scale (NRS) of radiating leg pain
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Radiating leg pain intensity for the past 3 days
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Baseline, 1, 2, 3, 6, 12 months
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Oswestry Disability Index (ODI)
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Functional disability questionnaire
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Baseline, 1, 2, 3, 6, 12 months
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EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Health-related quality of life questionnaire
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Baseline, 1, 2, 3, 6, 12 months
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Patient Global Impression of Change (PGIC)
Time Frame: 6, 12 months
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Global patient-reported outcome
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6, 12 months
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Current medical service use
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Current use of medical services (type, frequency, period)
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Baseline, 1, 2, 3, 6, 12 months
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Pain-free walking time
Time Frame: Baseline, 1, 2, 3, 6, 12 months
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Average pain-free walking time for the past 3 days
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Baseline, 1, 2, 3, 6, 12 months
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Physical examination
Time Frame: Baseline, 1, 2, 3 months
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Lumbar physical examination
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Baseline, 1, 2, 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jinho Lee, KMD, Ph.D., Jaseng Medical Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 4, 2017
Primary Completion (ACTUAL)
November 2, 2018
Study Completion (ACTUAL)
November 2, 2018
Study Registration Dates
First Submitted
November 22, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (ESTIMATE)
November 29, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 6, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2016-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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