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

NCT03879447 | Active Not Recruiting DMC

• 1 other identifier: JS-CT-2018-09
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Korean Medicine; Effectiveness; Numeric Rating Scale; Safety; Walking ability; Disability

Outcome Measures

Primary Outcomes (1)

• Change in Numeric rating scale (NRS) of higher score at baseline out of low back pain or radiating leg pain

  Change from higher score at baseline out of low back pain or radiating leg pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome)

  Change from baseline to 4 months

Secondary Outcomes (15)

• Numeric rating scale (NRS) of low back pain

  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

• Numeric rating scale (NRS) of radiating leg pain

  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

• Visual analogue scale (VAS) of low back pain

  Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

• Visual analogue scale (VAS) of radiating leg pain

  Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

• Oswestry Disability Index (ODI)

  Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

Study Arms (2)

Lumbar stenosis group

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.

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

Lumbar spondylolisthesis group

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.

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

Interventions

Herbal medicine DRUG

Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica) at the physician's discretion.

Also known as: Traditional herbal medicine

Lumbar spondylolisthesis group; Lumbar stenosis group

Chuna manual medicine PROCEDURE

Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.

Also known as: Chuna manipulation, Chuna spinal manipulation

Lumbar spondylolisthesis group; Lumbar stenosis group

Bee venom pharmacopuncture PROCEDURE

Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will usually be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).

Also known as: Bee venom acupuncture, Bee venom

Lumbar spondylolisthesis group; Lumbar stenosis group

Pharmacopuncture PROCEDURE

Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.

Lumbar spondylolisthesis group; Lumbar stenosis group

Acupuncture PROCEDURE

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Lumbar spondylolisthesis group; Lumbar stenosis group

Electroacupuncture PROCEDURE

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Lumbar spondylolisthesis group; Lumbar stenosis group

Cupping PROCEDURE

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Lumbar spondylolisthesis group; Lumbar stenosis group

Other intervention(s) PROCEDURE

Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.

Lumbar spondylolisthesis group; Lumbar stenosis group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lumbar stenosis or lumbar spondylolisthesis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Low Back Pain; Sciatica

Interventions

Phytotherapy; Bee Venoms; Acupuncture Therapy; Electroacupuncture; Cupping Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Arthropod Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Sun-A Kim, KMD

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Hyun-Woo Cho, KMD

  Haeundae Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Ji-Yun Seo, KMD

  Bucheon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

• Kyoung-Sun Park, KMD

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 18, 2019
• Study Start: June 24, 2019
• Primary Completion: March 3, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)