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
Study Type
OBSERVATIONAL
Enrollment
38
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).
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.
Jaseng Medical Foundation
Seoul, South Korea
Change in Numeric rating scale (NRS) of low back pain
Change in low back pain intensity
Time frame: Change from baseline to 3 months
Change in Numeric rating scale (NRS) of radiating leg pain
Change in radiating leg pain intensity
Time frame: Change from baseline to 3 months
Numeric rating scale (NRS) of low back pain
Low back pain intensity for the past 3 days
Time frame: Baseline, 1, 2, 3, 6, 12 months
Numeric rating scale (NRS) of radiating leg pain
Radiating leg pain intensity for the past 3 days
Time frame: Baseline, 1, 2, 3, 6, 12 months
Oswestry Disability Index (ODI)
Functional disability questionnaire
Time frame: Baseline, 1, 2, 3, 6, 12 months
EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Health-related quality of life questionnaire
Time frame: Baseline, 1, 2, 3, 6, 12 months
Patient Global Impression of Change (PGIC)
Global patient-reported outcome
Time frame: 6, 12 months
Current medical service use
Current use of medical services (type, frequency, period)
Time frame: Baseline, 1, 2, 3, 6, 12 months
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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).
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).
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.
Pain-free walking time
Average pain-free walking time for the past 3 days
Time frame: Baseline, 1, 2, 3, 6, 12 months
Physical examination
Lumbar physical examination
Time frame: Baseline, 1, 2, 3 months