Sciatica Due to Intervertebral Disc DisorderNCT03750591
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
An observational study of Sciatica Due to Intervertebral Disc Disorder and Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Sciatica Due to Intervertebral Disc Disorder, Intervertebral Disc Displacement, Sciatica
- What is being tested?
- Herbal medicine, Chuna manual therapy and Bee venom pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 31 Mar 2018to 8 Nov 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine
Who may be able to join
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
- Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
- Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
- Patients aged 19 to 70
- Patients who have agreed to participate in the clinical study and given written informed consent
- Patients admitted to a Korean medicine hospital for treatment
Who cannot join
- Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
- Patients admitted due to pain caused by traffic accidents
- Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
- Patients with severe mental illness
- Patients with difficulty or refusal to give sign written informed consent
- Patients for whom the researchers judge participation in the clinical study to be difficult
- Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan, 48102
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Jaseng Hospital of Korean Medicine
Seoul, 06110
About this study
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Read the detailed description
Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients
- Conditions
- Sciatica Due to Intervertebral Disc Disorder, Intervertebral Disc Displacement, Sciatica, Sciatic Radiculopathy
- Being tested
- Herbal medicine, Chuna manual therapy, Bee venom pharmacopuncture, Pharmacopuncture, Acupuncture
- Keywords
- Integrative Korean medicine, treatment, effectiveness, safety, Lumbar intervertebral disc herniation
- Medical subject headings
- Intervertebral Disc Displacement, 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 mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Chuna manual therapyProcedure or surgery
Also called Chuna manipulation, Chuna spinal manipulation
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
Chuna manipulation will be administered at the physician's discretion.
Bee venom pharmacopunctureProcedure or surgery
Also called Bee venom acupuncture
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 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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
PharmacopunctureProcedure or surgery
Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
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)Other
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Korean medicine treatment group | Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s) Receives: Drug: Herbal medicine; Procedure: Chuna manual therapy; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS change from Baseline NRS at discharge
Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using 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'.
Measured: Baseline (admission), discharge (up to 14 weeks after baseline)
ODI change from Baseline ODI at discharge
Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
Measured: Baseline (admission), discharge (up to 14 weeks after baseline)
PGIC
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).
Measured: 6 months after baseline
Secondary outcomes (6)
EQ-5D change from Baseline EQ-5D at each time point
EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
Measured: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline
Lumbar ROM from Baseline Lumbar ROM at each time point
Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed.
Measured: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
SLR from Baseline SLR at each time point
Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve).
If the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.[3] A negative test suggests a likely different cause for back pain.
Measured: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
AE
Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
Measured: up to 14 weeks after baseline
NRS change from Baseline NRS at each timepoint
Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using 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'.
Measured: Baseline (admission), 2 weeks after baseline, 6 months after baseline
ODI change from Baseline ODI at each timepoint
Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
Measured: Baseline (admission), 2 weeks after baseline, 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Mar 2018
- Primary completion10 May 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sciatica Due to Intervertebral Disc DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- HYUN WOO CHO, PhD, Principal investigator, Haeundae Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750591
- Sponsor's protocol ID
- JS-CT-2017-05-1
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2018
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim E, Yeo J, Kim MR, Kim MY, Kim J, Cho HW, Go HY, Ha IH, Lee YJ. Heterogeneity in effectiveness of conservative complementary and alternative medicine treatment for lumbar disc herniation: a latent trajectory analysis. Pain Med. 2026 Apr 1;27(4):434-442. doi: 10.1093/pm/pnaf139.
PubMed 41063378
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation
- ClinicalTrials.gov ID
- NCT03750591
- Acronym / sponsor ID
- JS-CT-2017-05-1
- Conditions
- Sciatica Due to Intervertebral Disc Disorder, Intervertebral Disc Displacement, Sciatica, Sciatic Radiculopathy
- Keywords
- Integrative Korean medicine, treatment, effectiveness, safety, Lumbar intervertebral disc herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation
Detailed description
Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction with an observational study to the aim of evaluating the effectiveness and safety of Korean medicine treatment for inpatients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Korean medicine treatment group | – | Drug: Herbal medicine, Procedure: Chuna manual therapy, Procedure: Bee venom pharmacopuncture, Procedure: Pharmacopuncture, Procedure: Acupuncture, Procedure: Electroacupuncture, Procedure: Cupping, Other: Other intervention(s)Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals Interventions: Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine
Key inclusion criteria (6 listed)
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
- Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
- Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
- Patients aged 19 to 70
- Patients who have agreed to participate in the clinical study and given written informed consent
Key exclusion criteria (7 listed)
- Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
- Patients admitted due to pain caused by traffic accidents
- Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
- Patients with severe mental illness
- Patients with difficulty or refusal to give sign written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal medicineAlso: Traditional herbal medicineHerbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica). | Drug | Integrative Korean medicine treatment group |
| Chuna manual therapyAlso: Chuna manipulation, Chuna spinal manipulationChuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered at the physician's discretion. | Procedure or surgery | Integrative Korean medicine treatment group |
| Bee venom pharmacopunctureAlso: Bee venom acupunctureBee 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 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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | Integrative Korean medicine treatment group |
| PharmacopuncturePharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | Integrative Korean medicine treatment group |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Integrative Korean medicine treatment group |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Integrative Korean medicine treatment group |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Integrative Korean medicine treatment group |
| Other intervention(s)Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study. | Other | Integrative Korean medicine treatment group |
Primary outcome
NRS change from Baseline NRS at discharge
Time frame: Baseline (admission), discharge (up to 14 weeks after baseline)
Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using 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'.
ODI change from Baseline ODI at discharge
Time frame: Baseline (admission), discharge (up to 14 weeks after baseline)
Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
PGIC
Time frame: 6 months after baseline
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).
6 secondary outcomes
EQ-5D change from Baseline EQ-5D at each time point
Time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline
Lumbar ROM from Baseline Lumbar ROM at each time point
Time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
SLR from Baseline SLR at each time point
Time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
AE
Time frame: up to 14 weeks after baseline
NRS change from Baseline NRS at each timepoint
Time frame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
ODI change from Baseline ODI at each timepoint
Time frame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 41063378Kim E, Yeo J, Kim MR, Kim MY, Kim J, Cho HW, Go HY, Ha IH, Lee YJ. Heterogeneity in effectiveness of conservative complementary and alternative medicine treatment for lumbar disc herniation: a latent trajectory analysis. Pain Med. 2026 Apr 1;27(4):434-442. doi: 10.1093/pm/pnaf139.
- Individual participant dataSharing planned: Undecided
Related trials for Sciatica Due to Intervertebral Disc Disorder
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial
Sciatica, Lumbar Disc Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HYUN WOO CHO, PhD principal investigator
Haeundae Jaseng Hospital of Korean Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica Due to Intervertebral Disc Disorder and Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 4 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NRS change from Baseline NRS at discharge (time frame: Baseline (admission), discharge (up to 14 weeks after baseline)). The study lists 3 primary outcomes in all. 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 NCT03750591, which also lists 1 linked publication.
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 13 Mar 2020.