Pharmacopuncture therapy for patients with lumbar spinal stenosis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0007145
- Lead Sponsor
- Jaseng Medical Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 98
1. Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
2. Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
3. reported radiating leg pain or low back pain (LBP) with intensity of NRS =5
4. Between the age of 19 and 69 years old.
5. Participants who agreed to participate the study and voluntarily signed the informed consent form.
1. Patients with vascular claudication
2. Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
3. Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
4. Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
5. Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
6. Patients for whom pharmacopuncture 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)
7. Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
8. Pregnant patients or patients planning pregnancy
9. Patients with medical history of spinal surgery within the past 3 months
10. 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
11. Patients unable to fill out study participation consent form
12. Patients deemed unsuitable for study participation as assessed by the researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in numeric rating scale, NRS
- Secondary Outcome Measures
Name Time Method umeric rating scale (NRS) of low back pain and radiating pain;Visual analogue scale (VAS) of low back pain and radiating pain;walking distance;Zurich Claudication Questionnaire (ZCQ);Oswestry disability index (ODI);Patient global impression of change;Short Form-12 Health Survey version 2, SF-12 v2;EuroQol-5 Dimension (EQ-5D-5L)