Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis
NCT ID: NCT03879447
Last Updated: 2025-12-23
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
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ACTIVE_NOT_RECRUITING
110 participants
OBSERVATIONAL
2019-06-24
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Lumbar stenosis group
Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Herbal medicine
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) at the physician's discretion.
Chuna manual medicine
Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine 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 manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Bee venom pharmacopuncture
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 usually 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).
Pharmacopuncture
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) at the physician's discretion.
Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
Lumbar spondylolisthesis group
Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Herbal medicine
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) at the physician's discretion.
Chuna manual medicine
Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine 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 manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Bee venom pharmacopuncture
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 usually 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).
Pharmacopuncture
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) at the physician's discretion.
Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
Interventions
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Herbal medicine
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) at the physician's discretion.
Chuna manual medicine
Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine 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 manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Bee venom pharmacopuncture
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 usually 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).
Pharmacopuncture
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) at the physician's discretion.
Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)
Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with lumbar stenosis based on dural sac cross-sectional area (DSCA) of \<100 mm2 or morphological grading ≥B as assessed on MRI; or patients diagnosed with lumbar spondylolisthesis based on Meyerding Grade Ⅱ or higher as assessed on X-ray
* Clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position), if lumbar stenosis patient
* Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥4 months
* Patients who have agreed to study participation
Exclusion Criteria
* 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)
* Patients with medical history of spinal surgery within the past 3 months
* Patients who were treated with invasive interventions such as Korean medicine treatment, injections, physical therapy, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
* Pregnant patients or patients planning pregnancy
* Patients with serious psychological disorders
* Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
* Patients unable to fill out study participation consent form
* Patients deemed unsuitable for study participation as assessed by the researchers
19 Years
75 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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In-Hyuk Ha, KMD
Director
Principal Investigators
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Sun-A Kim, KMD
Role: PRINCIPAL_INVESTIGATOR
Daejeon Jaseng Hospital of Korean Medicine
Hyun-Woo Cho, KMD
Role: PRINCIPAL_INVESTIGATOR
Haeundae Jaseng Hospital of Korean Medicine
Ji-Yun Seo, KMD
Role: PRINCIPAL_INVESTIGATOR
Bucheon Jaseng Hospital of Korean Medicine
Kyoung-Sun Park, KMD
Role: PRINCIPAL_INVESTIGATOR
Jaseng Hospital of Korean Medicine
Locations
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Jaseng Medical Foundation
Seoul, , South Korea
Countries
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Other Identifiers
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JS-CT-2018-09
Identifier Type: -
Identifier Source: org_study_id