Lumbar RadiculopathyNCT07832318
Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial
A study testing Pharmacopuncture and Physical Therapy in people with Lumbar Radiculopathy and Chronic Pain, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Lumbar Radiculopathy, Chronic Pain
- What is being tested?
- Pharmacopuncture and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 22 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Inclusion Criteria:
- Persistent sciatica symptoms lasting for more than 3 months.
- Presence of at least one of the following signs in one or both lower extremities: Muscle weakness / Dermatomal sensory disturbance (hypoesthesia, dysesthesia, tingling, or pain) / Decreased reflexes / Radiating pain aggravated by the Straight Leg Raising (SLR) test
- Numeric Rating Scale (NRS) score of 4 or higher for leg pain.
- Aged between 19 and 70 years.
- Provided written informed consent to participate in the clinical trial.
- Exclusion Criteria:
- Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis of cancer, acute vertebral fracture, or dislocation).
- Presence of progressive neurological deficits or severe neurological symptoms.
- Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
- Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).
- Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
- Inappropriate or unsafe conditions for pharmacopuncture, including bleeding disorders, anticoagulant therapy, or severe diabetes with high infection risk.
- Use of analgesic medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or receipt of acupuncture, pharmacopuncture, or physical therapy within the past 7 days.
- Pregnant, planning to become pregnant, or currently breastfeeding.
- Within 3 months post-lumbar spine surgery.
- Participation in another clinical trial within the past month, or planned participation in another clinical trial (including follow-up period) within 6 months from the screening date.
- Difficulty in completing the informed consent process.
- Any other condition that the investigator deems inappropriate for participation in the clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 1 recruiting
- Completed
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do
- Completed
Kyung Hee University Korean Medicine Hospital at Gangdong
Seongnam-si, Gyeonggi-do
- Completed
Jaseng Hospital of Korean Medicine
Seoul, Seoul
- Recruiting
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Seoul
Byung-Kwan Seo, KMD, 82-10-3431-5193, seohbk@hanmail.net
About this study
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy
Read the detailed description
This multicenter, pragmatic, randomized, comparative clinical trial aims to evaluate the effectiveness and safety of pharmacopuncture in patients with chronic lumbar radiculopathy. A total of 92 participants with chronic lumbar radiculopathy will be recruited from four traditional Korean medicine hospitals: Recruitment will follow a competitive enrollment scheme. Participants will be randomly assigned to one of two treatment strategy groups: a pharmacopuncture group (n = 46) and a physical therapy group (n = 46). As a pragmatic trial, the specific methods of pharmacopuncture and physical therapy will not be predetermined. Instead, treatment methods will be determined by the clinical judgment of the Korean medicine doctor according to each patient's individual condition. All administered treatments will be recorded in the patients' medical records and the Case Report Form (CRF) for later comparison.
The primary objective of this study is to assess the comparative effectiveness of pharmacopuncture against physical therapy in managing chronic lumbar radiculopathy symptoms in a real-world clinical setting.
- Conditions
- Lumbar Radiculopathy, Chronic Pain
- Being tested
- Pharmacopuncture, Physical Therapy
- Medical subject headings
- Radiculopathy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacopunctureProcedure or surgery
The physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
Physical TherapyProcedure or surgery
The physicians will decide the specific methods of physical therapy based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacopuncture group | Experimental | 1. Acupoints:
The selection of acupoints, needling depth, and other procedural details will be determined based on the clinical judgment of the Korean medicine doctor, taking into account the patient's symptoms, diagnostic imaging findings, and progress. All selected acupoints used for the treatment of chronic lumbar radiculopathy will be documented, and only those listed by the World Health Organization (WHO) will be used.
2. Pharmacopuncture Solution:
The type of pharmacopuncture solution and the dosage administered will be selected at the discretion of the practitioner performing the pharmacopuncture, based on their clinical judgment. The type and total volume (in milliliters) of the pharmacopuncture solution used will be recorded for retrospective chart review. The dosage will range from 0.1 cc to 10.0 cc, depending on the clinician's decision. The selection of pharmacopuncture solutions will be limited to those already in clinical use at each participating institution. Receives: Procedure: Pharmacopuncture |
| Physical Therapy Group | Active comparator | As this is a pragmatic clinical trial, the choice of physical therapy modality, treatment area, and treatment duration will be determined based on the clinical judgment of the physician, taking into account the patient's symptoms, imaging findings, and clinical progress. All types, frequencies, and sites of physical therapy prescribed and administered will be recorded. To improve symptoms and conditions related to lumbar radiculopathy, any mechanical physical therapy modality currently used in actual clinical practice will be permitted. Examples include Interference Current Therapy (ICT) and Transcutaneous Electrical Nerve Stimulation (TENS). Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg pain Numeric Rating Scale, NRS
Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain
Measured: Week 7
Secondary outcomes (8)
Leg and low back pain Numeric Rating Scale
The pain intensity of leg and low back over the past week
Measured: Week 1,2,3,4,5,6,7,13
Leg and low back pain Visual Analogue Scale
The pain intensity of leg and low back over the past week
Measured: Week 1,2,3,4,5,6,7
Oswestry Disability Index
The degree of low back disability in daily life
Measured: Week 1,7,13
Roland-Morris Disability Questionnaire
assesse the functional status of patients with low back pain
Measured: Week 1,7,13
Patient Global Impression of Change
The subject's subjective improvement
Measured: Week 7,13
Health-related Quality of Life Instrument with 8 Items
A tool developed to measure the health-related quality of life in Koreans
Measured: Week 1,7,13
5-Level EuroQol-5 Dimension
A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: Week 1,7,13
Adverse events
An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.
Measured: Week 1,2,3,4,5,6,7,13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start22 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832318
- Sponsor's protocol ID
- JS-CT-2024-10
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07832318
- Acronym / sponsor ID
- JS-CT-2024-10
- Conditions
- Lumbar Radiculopathy, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2026 (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.
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy
Detailed description
This multicenter, pragmatic, randomized, comparative clinical trial aims to evaluate the effectiveness and safety of pharmacopuncture in patients with chronic lumbar radiculopathy. A total of 92 participants with chronic lumbar radiculopathy will be recruited from four traditional Korean medicine hospitals: Recruitment will follow a competitive enrollment scheme. Participants will be randomly assigned to one of two treatment strategy groups: a pharmacopuncture group (n = 46) and a physical therapy group (n = 46). As a pragmatic trial, the specific methods of pharmacopuncture and physical therapy will not be predetermined. Instead, treatment methods will be determined by the clinical judgment of the Korean medicine doctor according to each patient's individual condition. All administered treatments will be recorded in the patients' medical records and the Case Report Form (CRF) for later comparison.
The primary objective of this study is to assess the comparative effectiveness of pharmacopuncture against physical therapy in managing chronic lumbar radiculopathy symptoms in a real-world clinical setting.
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: Pharmacopuncture1. Acupoints: The selection of acupoints, needling depth, and other procedural details will be determined based on the clinical judgment of the Korean medicine doctor, taking into account the patient's symptoms, diagnostic imaging findings, and progress. All selected acupoints used for the treatment of chronic lumbar radiculopathy will be documented, and only those listed by the World Health Organization (WHO) will be used. 2. Pharmacopuncture Solution: The type of pharmacopuncture solution and the dosage administered will be selected at the discretion of the practitioner performing the pharmacopuncture, based on their clinical judgment. The type and total volume (in milliliters) of the pharmacopuncture solution used will be recorded for retrospective chart review. The dosage will range from 0.1 cc to 10.0 cc, depending on the clinician's decision. The selection of pharmacopuncture solutions will be limited to those already in clinical use at each participating institution. |
| Physical Therapy Group | Active comparator | Procedure: Physical TherapyAs this is a pragmatic clinical trial, the choice of physical therapy modality, treatment area, and treatment duration will be determined based on the clinical judgment of the physician, taking into account the patient's symptoms, imaging findings, and clinical progress. All types, frequencies, and sites of physical therapy prescribed and administered will be recorded. To improve symptoms and conditions related to lumbar radiculopathy, any mechanical physical therapy modality currently used in actual clinical practice will be permitted. Examples include Interference Current Therapy (ICT) and Transcutaneous Electrical Nerve Stimulation (TENS). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PharmacopunctureThe physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms. | Procedure or surgery | Pharmacopuncture group |
| Physical TherapyThe physicians will decide the specific methods of physical therapy based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms. | Procedure or surgery | Physical Therapy Group |
Primary outcome
Leg pain Numeric Rating Scale, NRS
Time frame: Week 7
Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain
8 secondary outcomes
Leg and low back pain Numeric Rating Scale
Time frame: Week 1,2,3,4,5,6,7,13
Leg and low back pain Visual Analogue Scale
Time frame: Week 1,2,3,4,5,6,7
Oswestry Disability Index
Time frame: Week 1,7,13
Roland-Morris Disability Questionnaire
Time frame: Week 1,7,13
Patient Global Impression of Change
Time frame: Week 7,13
Health-related Quality of Life Instrument with 8 Items
Time frame: Week 1,7,13
5-Level EuroQol-5 Dimension
Time frame: Week 1,7,13
Adverse events
Time frame: Week 1,2,3,4,5,6,7,13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
In-Hyuk Ha study director
Jaseng Medical Foundation
4 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 Physical Therapy in people with Lumbar Radiculopathy and Chronic Pain, 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?
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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Hyuk Ha, Dr (1577-0007, hanihata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg pain Numeric Rating Scale, NRS (time frame: Week 7). 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 21 Sep 2026.