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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03879447
• Date of registration: 05/03/2019
• Prospective Registration: Yes
• Primary sponsor: Jaseng Medical Foundation
• Public title: Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis
• Scientific 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
• Date of first enrolment: June 24, 2019
• Target sample size: 110
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03879447
• Study type: Observational

Countries of recruitment

Korea, Republic of

Contacts

• Name: Hyun-Woo Cho, KMD
• Affiliation: Haeundae Jaseng Hospital of Korean Medicine

• Name: Kyoung-Sun Park, KMD
• Affiliation: Jaseng Hospital of Korean Medicine

• Name: Ji-Yun Seo, KMD
• Affiliation: Bucheon Jaseng Hospital of Korean Medicine

• Name: Sun-A Kim, KMD
• Affiliation: Daejeon Jaseng Hospital of Korean Medicine

Key inclusion & exclusion 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 ? 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



Age minimum: 19 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Low Back Pain

Neurogenic Claudication

Lumbar Spondylolisthesis

Sciatica

Lumbar Spinal Stenosis

Intervention(s)

Procedure: Electroacupuncture

Procedure: Other intervention(s)

Procedure: Bee venom pharmacopuncture

Procedure: Acupuncture

Procedure: Chuna manual medicine

Procedure: Cupping

Procedure: Pharmacopuncture

Drug: Herbal medicine

Primary Outcome(s)

Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain [Time Frame: Change from baseline to 4 months]

Secondary Outcome(s)

Maximum walking distance (average of the past 3 days) [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Numeric rating scale (NRS) of radiating leg pain [Time Frame: 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]

Oswestry Disability Index (ODI) [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Patient Global Impression of Change (PGIC) [Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years]

Numeric rating scale (NRS) of low back pain [Time Frame: 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]

Pain-free walking distance (average of the past 3 days) [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Adverse reaction [Time Frame: 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]

Zurich Claudication Questionnaire [Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

EuroQol 5-dimensions 5-levels (EQ-5D-5L) [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

SF-36 [Time Frame: [Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]]

EQ-VAS [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Physical examination [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Visual analogue scale (VAS) of low back pain [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Use of other intervention(s) [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Visual analogue scale (VAS) of radiating leg pain [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Secondary ID(s)

JS-CT-2018-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors