Lumbar Spinal StenosisNCT05242497
Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis
A study testing pharmacopuncture and conservative treatments (including physiotherapy) in people with Lumbar Spinal Stenosis, run by Jaseng Medical Foundation at 7 sites in South Korea.
Trial summary
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- pharmacopuncture and conservative treatments (including physiotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 13 Apr 2022to 28 Oct 2024
- Phase
- Interventional
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
- Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
- reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5
- Between the age of 19 and 69 years old.
- Participants who agreed to participate the study and voluntarily signed the informed consent form.
Who cannot join
- Patients with vascular claudication
- Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
- Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
- Patients for whom pharmacopuncture 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)
Show all 12Show fewer
- Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
- Pregnant patients or patients planning pregnancy
- Patients with medical history of spinal surgery within the past 3 months
- 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
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
Dongguk University Bundang Oriental Hospital
Seongnam-si, Bundang-gu, 13601
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, 130-701
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, 05278
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.
Read the detailed description
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. The physician will decide specific location, type, and doses of pharmacopuncture therapy or conservative treatments according to each participants' disease conditions, respectively. The researcher will record concurrently.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- pharmacopuncture, conservative treatments (including physiotherapy)
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacopunctureProcedure or surgery
This is a pragmatic randomized controlled trials, so the physicians will choose pharmacopuncture treatment, including the type and doses, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently.
conservative treatments (including physiotherapy)Procedure or surgery
This is a pragmatic randomized controlled trials, so the physicians will choose conservative treatment, including physiotherapy and pharmacological treatment, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently.
| Study group | Role | What they receive |
|---|---|---|
| pharmacopuncture group | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. Receives: Procedure: pharmacopuncture |
| conservative treatment group | Active comparator | The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions. Receives: Procedure: conservative treatments (including physiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
NRS is a pain scale in which the patients indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. The NRS of major painful site, which was chosen between low back and radiation pain in lower extremities, will be reported.
Measured: week 13
Secondary outcomes (8)
Numeric rating scale (NRS) of low back pain and radiating pain
NRS is a pain scale in which the patients indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Visual analogue scale (VAS) of low back pain and radiating pain
The patient indicates their pain severity from minimum 0 to maximum 100, which is a higher score means a worse outcome. VAS of low back pain and radiating leg pain will be reported.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Walking distance
Claudication-free walking distance and maximal walking distance will be evaluated.
Measured: week 1, 5, 9, 13, 25, 53
Zurich Claudication Questionnaire (ZCQ)
ZCQ is a lumbar spinal stenosis-specific patient reported outcome, which evaluate the disease severity, functional scale and satisfaction at the treatment.
Measured: week 1, 5, 9, 13, 25, 53
Oswestry disability index (ODI)
ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).
Measured: week 1, 5, 9, 13, 25, 53
PGIC
Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
Measured: week 13, 25, 53
Short Form-12 Health Survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Measured: week 1, 5, 9, 13, 25, 53
EuroQol-5 Dimension (EQ-5D-5L)
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Measured: week 1, 5, 9, 13, 25, 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start13 Apr 2022
- Primary completion19 Jan 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
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
- In-Hyuk Ha, KMD, Ph.D, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242497
- Sponsor's protocol ID
- JS-CT-2021-14
- Status last verified
- Oct 2024
- First submitted
- 15 Feb 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SW, Ahn YJ, Kim S, Lee Y, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. Pharmacopuncture therapy versus usual care for lumbar spinal stenosis: A randomized controlled trial. Integr Med Res. 2026 Sep;15(3Part A):101323. doi: 10.1016/j.imr.2026.101323. Epub 2026 Mar 28.
PubMed 42099446Lee JY, Park KS, Kim S, Seo JY, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study. J Pain Res. 2022 Sep 23;15:2989-2996. doi: 10.2147/JPR.S382550. eCollection 2022.
PubMed 36176963
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis : Multicentered, Pragmatic Randomized Controlled, Parallel Grouped Study
- ClinicalTrials.gov ID
- NCT05242497
- Acronym / sponsor ID
- JS-CT-2021-14
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 16 Feb 2022 (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.
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments.
Detailed description
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the conservative treatments including physiotherapy and pharmacological treatments. The physician will decide specific location, type, and doses of pharmacopuncture therapy or conservative treatments according to each participants' disease conditions, respectively. The researcher will record concurrently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacopuncture group | Experimental | Procedure: pharmacopunctureThe physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
| conservative treatment group | Active comparator | Procedure: conservative treatments (including physiotherapy)The physicians will choose the type and time of physical therapy and if needed, pharmacological treatment according to participants' conditions. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
- Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
- reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5
- Between the age of 19 and 69 years old.
- Participants who agreed to participate the study and voluntarily signed the informed consent form.
Key exclusion criteria (12 listed)
- Patients with vascular claudication
- Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
- Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
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 |
|---|---|---|
| pharmacopunctureThis is a pragmatic randomized controlled trials, so the physicians will choose pharmacopuncture treatment, including the type and doses, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently. | Procedure or surgery | pharmacopuncture group |
| conservative treatments (including physiotherapy)This is a pragmatic randomized controlled trials, so the physicians will choose conservative treatment, including physiotherapy and pharmacological treatment, according to each participant's conditions. The researcher will record the specific intervention precisely and concurrently. | Procedure or surgery | conservative treatment group |
Primary outcome
Numeric rating scale (NRS)
Time frame: week 13
NRS is a pain scale in which the patients indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. The NRS of major painful site, which was chosen between low back and radiation pain in lower extremities, will be reported.
8 secondary outcomes
Numeric rating scale (NRS) of low back pain and radiating pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Visual analogue scale (VAS) of low back pain and radiating pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 25, 53
Walking distance
Time frame: week 1, 5, 9, 13, 25, 53
Zurich Claudication Questionnaire (ZCQ)
Time frame: week 1, 5, 9, 13, 25, 53
Oswestry disability index (ODI)
Time frame: week 1, 5, 9, 13, 25, 53
PGIC
Time frame: week 13, 25, 53
Short Form-12 Health Survey version 2 (SF-12 v2)
Time frame: week 1, 5, 9, 13, 25, 53
EuroQol-5 Dimension (EQ-5D-5L)
Time frame: week 1, 5, 9, 13, 25, 53
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 9 Jan 2025.
- Derived from this study: PubMed 42099446Lee SW, Ahn YJ, Kim S, Lee Y, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. Pharmacopuncture therapy versus usual care for lumbar spinal stenosis: A randomized controlled trial. Integr Med Res. 2026 Sep;15(3Part A):101323. doi: 10.1016/j.imr.2026.101323. Epub 2026 Mar 28.
- Derived from this study: PubMed 36176963Lee JY, Park KS, Kim S, Seo JY, Cho HW, Nam D, Park Y, Kim EJ, Lee YJ, Ha IH. The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study. J Pain Res. 2022 Sep 23;15:2989-2996. doi: 10.2147/JPR.S382550. eCollection 2022.
- 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.
In-Hyuk Ha, KMD, Ph.D study director
Jaseng Medical Foundation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacopuncture and conservative treatments (including physiotherapy) in people with Lumbar Spinal Stenosis, run by Jaseng Medical Foundation at 7 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 5 inclusion and 12 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Numeric rating scale (NRS) (time frame: week 13). 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 NCT05242497, which also lists 2 linked publications.
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 9 Jan 2025.