An observational study in Low Back Pain, Sciatica and Intervertebral Disc Displacement, sponsored by Jaseng Medical Foundation. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2018-06-04.
Sponsored by Jaseng Medical Foundation · Observational
Among 11 studies in Low Back Pain by Jaseng Medical Foundation — 4 open to participants now, 5 under way, none of them phase 3. Low Back Pain · Jaseng Medical Foundation.
Among the 11 studies in Low Back Pain by Jaseng Medical Foundation, this one is the only one that started in 2018, is one of 3 observational ones, and was the 1st registered.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →4 of the 11 studies in Low Back Pain by Jaseng Medical Foundation are open now, in 1 country. Each count lists the studies.
Of the 333 Low Back Pain studies recruiting now, 92 (28%) set no upper age limit and 211 (63%) stop at 75 or younger; 8 take children under 18; 46 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 1 started in 2018.
Median enrollment 98 across the 8 interventional studies, 110 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.
1 of the studies in Low Back Pain by Jaseng Medical Foundation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07058376Jaseng Medical FoundationClinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain | 2026-12-31 |
Among the 11 studies in Low Back Pain by Jaseng Medical Foundation, from their registry updates:
Nothing recorded among them since 2026-09-25.
This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients who received integrative Korean medicine treatment for 24 weeks as part of a previous clinical study.
This observational study will assess the long-term course and effect of Korean medicine treatment in lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007, and give written informed consent to long-term follow-up assessment at 10 years.
Lumbar intervertebral disc herniation patients with a main complaint of radiating leg pain who received integrative Korean medicine treatment for 24 weeks at Jaseng Hospital of Korean Medicine (Gangnam main branch) as part of a previous clinical study which was conducted from November, 2006 to April, 2007.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No interventions will be administered (Magnetic Resonance Imaging (MRI) will be administered as an outcome measurement).
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Changes in size and severity of the main herniated disc causing radiating pain will be evaluated by radiology specialists and Korean medicine doctors (KMDs) and categorized into three groups (improved, worse or no discernible change) in comparison with the immediate previous MRI to track long-term changes and assess for correlations in subjective clinical symptoms and objective physical evaluation and MRI results.
Change in Visual Analogue Scale (VAS) of radiating leg pain
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain, and a greater change from baseline (If baseline - follow up is a positive value) indicates a better outcome.
Time frame: Difference from baseline at 10 years
Visual Analogue Scale (VAS) of low back pain
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.
Time frame: Baseline, and 10 years
Visual Analogue Scale (VAS) of radiating leg pain
Visual Analogue Scale (VAS) uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain (minimum score: 0)' and 'worst pain imaginable (maximum score: 100)'. Total scores are recorded in millimeters with a total range of 0-100 millimeters. Higher VAS values represent more severe pain.
Time frame: Baseline, and 10 years
Numeric Rating Scale (NRS) of low back pain
In pain measurement using Numeric Rating Scale (NRS), patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
Time frame: Baseline, and 10 years
Numeric Rating Scale (NRS) of radiating leg pain
In pain measurement using Numeric Rating Scale (NRS), patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 (minimum score) which indicates 'no pain', and 10 (maximum score) which indicates 'worst pain possible'. Higher NRS values represent more severe pain.
Time frame: Baseline, and 10 years
Oswestry Disability Index (ODI)
The ODI is a 10-item questionnaire developed to assess level of disability due to low back pain (LBP). Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to LBP.
Time frame: Baseline, 10 years
36-Item Short Form Survey (SF-36)
SF-36 consists of 36 items across 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. SF-36 is used to rate functional health and well-being in patients and healthy individuals. Higher scores indicate better HRQoL.
Time frame: Baseline, 10 years
Patient Global Impression of Change (PGIC)
PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
Time frame: Baseline, 10 years
Lumbar range of movement (ROM)
ROM measurements are valid (r=0.97) and reliable (r=0.94), but not highly responsive (effect size=0.1-0.6). If ROM is uncheckable from pain, the angle will be recorded as 0°.
Time frame: Baseline, 10 years
Straight leg raise (SLR) test
While SLR measurements are reliable (intraclass correlation coefficient=0.95), they are not very responsive (effect size=0.2). If SLR is uncheckable from pain, the angle will be recorded as 0°.
Time frame: Baseline, 10 years
Qualitative questionnaire on 10 year course
The qualitative questionnaire on 10 year course and outcome since receiving integrative Korean medicine treatment used in this study is a 14-item descriptive evaluation encompassing various items (a mixture of short-answer questions, multiple choices, and transcript of essay form answers) on the change before and after treatment over the course of 10 years (e.g. change in perception of surgery and non-surgical treatment, change in everyday life or habits, and treatment recommendation to others).
Time frame: 10 years
Medical history
Physicians will rate the causal relationship of each treatment from the previous clinical study with the patient's medical history potentially associated with treatment on a 6-point scale (1, definitely related; 2, probably related; 3, possibly related; 4, probably not related; 5, definitely not related; and 6, unknown), and classify all medical history potentially associated with treatment with the Spilker classification, which has 3 grades (1, mild: no intervention needed and does not greatly impede normal activity (function) of patient; 2, moderate: significantly impedes normal activity (function) of patient, and may need intervention, with subsequent resolution; 3, severe: severe adverse event needing intensive intervention, leaving sequela).
Time frame: 10 years
Adverse events
Adverse events potentially associated with MRI will be assessed.
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Jaseng Medical Foundation