An observational study in Lumbar Spinal Stenosis, Lumbar Spondylolisthesis and Low Back Pain, sponsored by Jaseng Medical Foundation. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Jaseng Medical Foundation · Observational
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
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
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's enrollment of 110 is close to the median of 120 across 154 observational studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.
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Lumbar stenosis or lumbar spondylolisthesis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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)
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
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
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
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.
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
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.
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)
Time frame: Change from baseline to 4 months
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)
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
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)
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
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Patient Global Impression of Change (PGIC)
Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)
Time frame: 8, 16, 20, 24 weeks, 1, 3, 5 years
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)
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Physical examination
Lumbar physical examination
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Adverse reaction
Safety
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
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.
Time frame: [Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]
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'.
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Mar 2022, 32 months.
Of 62 non-industry observational studies under Spinal Stenosis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 84. This study's 32 months is below that.
Counting every sponsor, half of 78 studies reached it within 51 months; a quarter within 23 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Jaseng Medical Foundation