Clinical trial NCT02975011: Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica
Official title: Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lumbar Spinal Stenosis
Keywords: Magnetic Resonance Imaging
Patient Satisfaction
Numeric Rating Scale
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations of Jaseng Hospital of Korean Medicine between November 2016 and March 2018

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Numeric rating scale (NRS) of low back pain
timeFrame: Change from baseline to 3 months
measure: Change in Numeric rating scale (NRS) of radiating leg pain
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Numeric rating scale (NRS) of low back pain
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Numeric rating scale (NRS) of radiating leg pain
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: EuroQol 5-dimensions 5-levels (EQ-5D-5L)
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Patient Global Impression of Change (PGIC)
timeFrame: 6, 12 months
measure: Current medical service use
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Pain-free walking time
timeFrame: Baseline, 1, 2, 3, 6, 12 months
measure: Physical examination
timeFrame: Baseline, 1, 2, 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Jaseng Medical Foundation
name: Jinho Lee, KMD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: