Lumbar Spinal Stenosis
Conditions
Keywords
Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale
Brief summary
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
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
Interventions
DRUGHerbal 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).
PROCEDUREChuna manipulation
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.
PROCEDUREBee 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 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).
PROCEDUREPharmacopuncture
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).
PROCEDUREAcupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
PROCEDUREElectroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
PROCEDURECupping
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.
Sponsors
Jaseng Medical Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric rating scale (NRS) of low back pain | Change from baseline to 3 months | Change in low back pain intensity |
| Change in Numeric rating scale (NRS) of radiating leg pain | Change from baseline to 3 months | Change in radiating leg pain intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Baseline, 1, 2, 3, 6, 12 months | Functional disability questionnaire |
| EuroQol 5-dimensions 5-levels (EQ-5D-5L) | Baseline, 1, 2, 3, 6, 12 months | Health-related quality of life questionnaire |
| Patient Global Impression of Change (PGIC) | 6, 12 months | Global patient-reported outcome |
| Numeric rating scale (NRS) of low back pain | Baseline, 1, 2, 3, 6, 12 months | Low back pain intensity for the past 3 days |
| Pain-free walking time | Baseline, 1, 2, 3, 6, 12 months | Average pain-free walking time for the past 3 days |
| Physical examination | Baseline, 1, 2, 3 months | Lumbar physical examination |
| Current medical service use | Baseline, 1, 2, 3, 6, 12 months | Current use of medical services (type, frequency, period) |
| Numeric rating scale (NRS) of radiating leg pain | Baseline, 1, 2, 3, 6, 12 months | Radiating leg pain intensity for the past 3 days |
Countries
South Korea
Outcome results
None listed