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Lumbar Spinal StenosisNCT03879447

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

An observational study of Lumbar Spinal Stenosis and Lumbar Spondylolisthesis, run by Jaseng Medical Foundation at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Herbal medicine, Chuna manual medicine and Bee venom pharmacopuncture
How many people
110 participants
Where
1 siteSouth Korea
Study dates
24 Jun 2019to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Lumbar stenosis or lumbar spondylolisthesis

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jaseng Medical Foundation

    Seoul

Other trials in South Korea

About this study

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

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

Read the 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

Being tested
Herbal medicine, Chuna manual medicine, Bee venom pharmacopuncture, Pharmacopuncture, Acupuncture
Keywords
Korean Medicine, Effectiveness, Numeric Rating Scale, Safety, Walking ability, Disability
Medical subject headings
Spinal Stenosis, Spondylolisthesis, Low Back Pain, Sciatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Herbal medicineDrug

    Also called Traditional herbal medicine

    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.

  • Chuna manual medicineProcedure or surgery

    Also called Chuna manipulation, Chuna spinal manipulation

    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.

  • Bee venom pharmacopunctureProcedure or surgery

    Also called Bee venom acupuncture, Bee venom

    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).

  • PharmacopunctureProcedure or surgery

    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.

  • AcupunctureProcedure or surgery

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

  • ElectroacupunctureProcedure or surgery

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

  • CuppingProcedure or surgery

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

  • Other intervention(s)Procedure or surgery

    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.

Study groups in NCT03879447
Study groupRoleWhat they receive
Lumbar stenosis groupLumbar 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.
Receives: 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 groupLumbar 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.
Receives: Drug: Herbal medicine; Procedure: Chuna manual medicine; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Procedure: Other intervention(s)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Change from baseline to 4 months

Secondary outcomes (15)

  1. Numeric rating scale (NRS) of low back pain

    Low back pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)

    Measured: 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

  2. Numeric rating scale (NRS) of radiating leg pain

    Radiating leg pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)

    Measured: 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

  3. Visual analogue scale (VAS) of low back pain

    Low back pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)

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

  4. Visual analogue scale (VAS) of radiating leg pain

    Radiating leg pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)

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

  5. Oswestry Disability Index (ODI)

    Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 100 (worse outcome)

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

  6. Pain-free walking distance (average of the past 3 days)

    Walking ability. Average pain-free walking distance during the past 3 days as recalled at each timepoint defined in Time Frame. Total score range: 0 (worse outcome) to no maximum limit (better outcome)

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

  7. Maximum walking distance (average of the past 3 days)

    Walking ability. Average maximum walking distance during the past 3 days as recalled at each timepoint defined in Time Frame. Total score range: 0 (worse outcome) to no maximum limit (better outcome)

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

  8. Zurich Claudication Questionnaire

    Claudication questionnaire. There are 12 questions for all patients, and a further 6 questions to measure treatment outcomes for those who have received treatment. The The Zurich Claudication Questionnaire consists of three subscales: (1) Symptom severity scale (items 1-7) which are subdivided into a pain domain (items 1-4) and a neuroischemic domain (items 5-7)]: The possible range of each item score is 1 to 5. (2) Physical function scale (items 8-12): The possible range of each item score is 1 to 4. (3) Patient satisfaction with treatment scale (questions 13-18): The possible range of each item score is 1 to 4. The result is expressed as a percentage of the maximum possible score. Total score range: 0% (better outcome) to 100% (worse outcome)

    Measured: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years

  9. EuroQol 5-dimensions 5-levels (EQ-5D-5L)

    Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)

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

  10. Patient Global Impression of Change (PGIC)

    Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)

    Measured: 8, 16, 20, 24 weeks, 1, 3, 5 years

  11. Use of other intervention(s)

    Use of any other additional intervention(s) other than the integrative Korean medicine treatment administered by the attending physician (start date of treatment, end date of treatment, name of treatment, number of treatment sessions received, and other comments)

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

  12. Physical examination

    Lumbar physical examination

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

  13. Adverse reaction

    Safety

    Measured: 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

  14. SF-36

    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

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

  15. EQ-VAS

    The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start24 Jun 2019
  3. Primary completion3 Mar 2022
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879447
Sponsor's protocol ID
JS-CT-2018-09
Status last verified
Dec 2025
First submitted
5 Mar 2019
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spinal Stenosis and Lumbar Spondylolisthesis, run by Jaseng Medical Foundation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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