Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/… (NCT03879447) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis
South Korea110 participantsStarted 2019-06-24
Plain-language summary
A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes
Who can participate
Age range19 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with radiating leg pain or low back pain (LBP) intensity of NRS ≥5
* 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 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)
* 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 therap…
What they're measuring
1
Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain