Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/spondylolisthesis

Jaseng Medical Foundation

Status: Active, not recruiting

Conditions: Lumbar Spondylolisthesis; Lumbar Spinal Stenosis; Neurogenic Claudication; Sciatica; Low Back Pain

Treatments: Procedure: Pharmacopuncture; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manual medicine; Drug: Herbal medicine; Procedure: Cupping; Procedure: Electroacupuncture; Procedure: Other intervention(s); Procedure: Acupuncture

Study type: Observational

Funder types: Other

Identifiers

NCT03879447

JS-CT-2018-09

Details and patient eligibility

About

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

Full description

This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica diagnosed by lumbar X-ray and/or MRI and clinical symptoms including neurogenic claudication at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes with a 5-year follow-up period

Enrollment: 110 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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 therapy, or with medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs) within the past week
• Pregnant patients or patients planning pregnancy
• Patients with serious psychological disorders
• 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
• Patients unable to fill out study participation consent form
• Patients deemed unsuitable for study participation as assessed by the researchers

Trial design

110 participants in 2 patient groups

Lumbar stenosis group

Description:

Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.

Treatment:

Procedure: Acupuncture

Procedure: Other intervention(s)

Procedure: Electroacupuncture

Procedure: Cupping

Procedure: Bee venom pharmacopuncture

Procedure: Chuna manual medicine

Drug: Herbal medicine

Procedure: Pharmacopuncture

Lumbar spondylolisthesis group

Description:

Lumbar spondylolisthesis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.

Treatment:

Procedure: Acupuncture

Procedure: Other intervention(s)

Procedure: Electroacupuncture

Procedure: Cupping

Procedure: Bee venom pharmacopuncture

Procedure: Chuna manual medicine

Drug: Herbal medicine

Procedure: Pharmacopuncture