Lumbar Spinal StenosisNCT02975011
Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica
An observational study of Lumbar Spinal Stenosis, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Herbal medicine, Chuna manipulation and Bee venom pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2017to 2 Nov 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations of Jaseng Hospital of Korean Medicine between November 2016 and March 2018
Who may be able to join
- Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4)
- Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI
- Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)
- Patients who have received surgery recommendation for lumbar spinal stenosis
- Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 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)
- Pregnant patients or patients planning pregnancy
- Patients with serious psychological disorders
- Patients unable to fill out study participation consent form
- Subjects deemed unsuitable for study participation as assessed by the researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study
A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life
Read the detailed description
This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Herbal medicine, Chuna manipulation, Bee venom pharmacopuncture, Pharmacopuncture, Acupuncture
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale
- Medical subject headings
- Spinal Stenosis, Patient Satisfaction
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).
Chuna manipulationProcedure or surgery
Also called Chuna spinal manipulation
Chuna is a Korean spinal manipulation that incorporates spinal manipulation 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 manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae 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, 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).
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 |
|---|---|---|
| Lumbar stenosis group | Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. Receives: Drug: Herbal medicine; Procedure: Chuna manipulation; 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.
Change in Numeric rating scale (NRS) of low back pain
Change in low back pain intensity
Measured: Change from baseline to 3 months
Change in Numeric rating scale (NRS) of radiating leg pain
Change in radiating leg pain intensity
Measured: Change from baseline to 3 months
Secondary outcomes (8)
Numeric rating scale (NRS) of low back pain
Low back pain intensity for the past 3 days
Measured: Baseline, 1, 2, 3, 6, 12 months
Numeric rating scale (NRS) of radiating leg pain
Radiating leg pain intensity for the past 3 days
Measured: Baseline, 1, 2, 3, 6, 12 months
Oswestry Disability Index (ODI)
Functional disability questionnaire
Measured: Baseline, 1, 2, 3, 6, 12 months
EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Health-related quality of life questionnaire
Measured: Baseline, 1, 2, 3, 6, 12 months
Patient Global Impression of Change (PGIC)
Global patient-reported outcome
Measured: 6, 12 months
Current medical service use
Current use of medical services (type, frequency, period)
Measured: Baseline, 1, 2, 3, 6, 12 months
Pain-free walking time
Average pain-free walking time for the past 3 days
Measured: Baseline, 1, 2, 3, 6, 12 months
Physical examination
Lumbar physical examination
Measured: Baseline, 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start4 Mar 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Why it stopped: This study was prematurely terminated due to delayed patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinho Lee, Jaseng Medical Foundation
- Investigators
- Jinho Lee, KMD, Ph.D., Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975011
- Sponsor's protocol ID
- JS-CT-2016-03
- Status last verified
- Nov 2018
- First submitted
- 22 Nov 2016
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study
- ClinicalTrials.gov ID
- NCT02975011
- Acronym / sponsor ID
- JS-CT-2016-03
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Magnetic Resonance Imaging, Patient Satisfaction, Numeric Rating Scale
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was prematurely terminated due to delayed patient enrollment.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life
Detailed description
This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar stenosis group | – | Drug: Herbal medicine, Procedure: Chuna manipulation, Procedure: Bee venom pharmacopuncture, Procedure: Pharmacopuncture, Procedure: Acupuncture, Procedure: Electroacupuncture, Procedure: Cupping, Other: Other intervention(s)Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations of Jaseng Hospital of Korean Medicine between November 2016 and March 2018
Key inclusion criteria (6 listed)
- Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS ≥4)
- Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading ≥B as assessed on MRI
- Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)
- Patients who have received surgery recommendation for lumbar spinal stenosis
- Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for ≥2 months
Key exclusion criteria (8 listed)
- 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)
- Pregnant patients or patients planning pregnancy
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 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). | Drug | Lumbar stenosis group |
| Chuna manipulationAlso: Chuna spinal manipulationChuna is a Korean spinal manipulation that incorporates spinal manipulation 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 manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion. | Procedure or surgery | Lumbar stenosis 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, 26G x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | Lumbar stenosis group |
| PharmacopuncturePharmacopuncture 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). | Procedure or surgery | Lumbar stenosis group |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Lumbar stenosis group |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Lumbar stenosis group |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Lumbar stenosis 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 | Lumbar stenosis group |
Primary outcome
Change in Numeric rating scale (NRS) of low back pain
Time frame: Change from baseline to 3 months
Change in low back pain intensity
Change in Numeric rating scale (NRS) of radiating leg pain
Time frame: Change from baseline to 3 months
Change in radiating leg pain intensity
8 secondary outcomes
Numeric rating scale (NRS) of low back pain
Time frame: Baseline, 1, 2, 3, 6, 12 months
Numeric rating scale (NRS) of radiating leg pain
Time frame: Baseline, 1, 2, 3, 6, 12 months
Oswestry Disability Index (ODI)
Time frame: Baseline, 1, 2, 3, 6, 12 months
EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Time frame: Baseline, 1, 2, 3, 6, 12 months
Patient Global Impression of Change (PGIC)
Time frame: 6, 12 months
Current medical service use
Time frame: Baseline, 1, 2, 3, 6, 12 months
Pain-free walking time
Time frame: Baseline, 1, 2, 3, 6, 12 months
Physical examination
Time frame: Baseline, 1, 2, 3 months
Results and safety
The study was stopped early (reason given: This study was prematurely terminated due to delayed patient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Jinho Lee, KMD, Ph.D. principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Nov 2018. 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?
The study was stopped early (reason given: This study was prematurely terminated due to delayed patient enrollment.). Results are not available in the source record.
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 low back pain (time frame: Change from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2018.