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This study was prematurely terminated due to delayed patient enrollment.
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal medicine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric rating scale (NRS) of low back pain | Change in low back pain intensity | Change from baseline to 3 months |
| Change in Numeric rating scale (NRS) of radiating leg pain | Change in radiating leg pain intensity | Change from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS) of low back pain | Low back pain intensity for the past 3 days | Baseline, 1, 2, 3, 6, 12 months |
| Numeric rating scale (NRS) of radiating leg pain | Radiating leg pain intensity for the past 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jinho Lee, KMD, Ph.D. | Jaseng Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaseng Medical Foundation | Seoul | South Korea |
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| Chuna manipulation | Procedure | 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. |
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| Bee venom pharmacopuncture | Procedure | 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). |
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| Pharmacopuncture | Procedure | 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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| Acupuncture | Procedure | Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
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| Electroacupuncture | Procedure | Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. |
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| Cupping | Procedure | Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. |
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| Other intervention(s) | Other | 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. |
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| Baseline, 1, 2, 3, 6, 12 months |
| Oswestry Disability Index (ODI) | Functional disability questionnaire | Baseline, 1, 2, 3, 6, 12 months |
| EuroQol 5-dimensions 5-levels (EQ-5D-5L) | Health-related quality of life questionnaire | Baseline, 1, 2, 3, 6, 12 months |
| Patient Global Impression of Change (PGIC) | Global patient-reported outcome | 6, 12 months |
| Current medical service use | Current use of medical services (type, frequency, period) | Baseline, 1, 2, 3, 6, 12 months |
| Pain-free walking time | Average pain-free walking time for the past 3 days | Baseline, 1, 2, 3, 6, 12 months |
| Physical examination | Lumbar physical examination | Baseline, 1, 2, 3 months |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| D000079742 | Cupping Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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