Clinical trial NCT03879447: Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/spondylolisthesis
Official title: Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients with Low Back Pain or Sciatica Due to Lumbar Stenosis or Spondylolisthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Spinal Stenosis
Lumbar Spondylolisthesis
Low Back Pain
Sciatica
Neurogenic Claudication
Keywords: Korean Medicine
Effectiveness
Numeric Rating Scale
Safety
Walking ability
Disability
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 110
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 or lumbar spondylolisthesis

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain
timeFrame: Change from baseline to 4 months
Secondary outcomes:
measure: Numeric rating scale (NRS) of low back pain
timeFrame: Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years
measure: Numeric rating scale (NRS) of radiating leg pain
timeFrame: Baseline, observation at least once a week for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years
measure: Visual analogue scale (VAS) of low back pain
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Visual analogue scale (VAS) of radiating leg pain
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Pain-free walking distance (average of the past 3 days)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Maximum walking distance (average of the past 3 days)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Zurich Claudication Questionnaire
timeFrame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: EuroQol 5-dimensions 5-levels (EQ-5D-5L)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Patient Global Impression of Change (PGIC)
timeFrame: 8, 16, 20, 24 weeks, 1, 3, 5 years
measure: Use of other intervention(s)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Physical examination
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Adverse reaction
timeFrame: Baseline, every visit for the duration of active treatment up to a maximum of 24 weeks (2, 4, 6, 8, 12, 16, 20, 24 weeks), 1, 3, 5 years
measure: SF-36
timeFrame: [Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]
measure: EQ-VAS
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sun-A Kim, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haeundae Jaseng Hospital of Korean Medicine
name: Hyun-Woo Cho, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon Jaseng Hospital of Korean Medicine
name: Ji-Yun Seo, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaseng Hospital of Korean Medicine
name: Kyoung-Sun Park, KMD
role: PRINCIPAL_INVESTIGATOR
References: