Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica

Terminated

• Conditions: Lumbar Spinal Stenosis
• Interventions: Drug: Herbal medicine; Procedure: Chuna manipulation; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s)

• Registration Number: NCT02975011
• Lead Sponsor: Jaseng Medical Foundation

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

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Study Start: 2017-03-04
• Status Verified: 2018-11
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar stenosis group	Herbal medicine	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Chuna manipulation	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Bee venom pharmacopuncture	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Pharmacopuncture	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Acupuncture	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Electroacupuncture	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Cupping	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
Lumbar stenosis group	Other intervention(s)	Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.

Primary Outcome Measures

Name	Time	Method
Change in Numeric rating scale (NRS) of low back pain	Change from baseline to 3 months	Change in low back pain intensity
Change in Numeric rating scale (NRS) of radiating leg pain	Change from baseline to 3 months	Change in radiating leg pain intensity

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale (NRS) of low back pain	Baseline, 1, 2, 3, 6, 12 months	Low back pain intensity for the past 3 days
Physical examination	Baseline, 1, 2, 3 months	Lumbar physical examination
Pain-free walking time	Baseline, 1, 2, 3, 6, 12 months	Average pain-free walking time for the past 3 days
Numeric rating scale (NRS) of radiating leg pain	Baseline, 1, 2, 3, 6, 12 months	Radiating leg pain intensity for the past 3 days
Oswestry Disability Index (ODI)	Baseline, 1, 2, 3, 6, 12 months	Functional disability questionnaire
EuroQol 5-dimensions 5-levels (EQ-5D-5L)	Baseline, 1, 2, 3, 6, 12 months	Health-related quality of life questionnaire
Current medical service use	Baseline, 1, 2, 3, 6, 12 months	Current use of medical services (type, frequency, period)
Patient Global Impression of Change (PGIC)	6, 12 months	Global patient-reported outcome

Trial Locations

Locations (1)

Jaseng Medical Foundation; 🇰🇷 Seoul, Korea, Republic of