ClinicalTrials.gg
RecruitingNCT07832318Updated Sep 21, 2026

Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial

An interventional study of Pharmacopuncture and Physical Therapy in Lumbar Radiculopathy and Chronic Pain, sponsored by Jaseng Medical Foundation. Recruiting at 4 sites in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Jaseng Medical Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lumbar Radiculopathy
  • Chronic Pain
03

In context

Radiculopathy

483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.

This study's planned enrollment of 92 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

1. Inclusion Criteria:

  1. Persistent sciatica symptoms lasting for more than 3 months.
  2. 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
  3. Numeric Rating Scale (NRS) score of 4 or higher for leg pain.
  4. Aged between 19 and 70 years.
  5. Provided written to participate in the clinical trial.

2. Exclusion Criteria:

  1. Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal of cancer, acute vertebral fracture, or dislocation).
  2. Presence of progressive neurological deficits or severe neurological symptoms.
  3. Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
  4. Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).
  5. Current use of , , psychiatric medications, or other drugs that may affect study outcomes.
  6. Inappropriate or unsafe conditions for pharmacopuncture, including bleeding disorders, anticoagulant therapy, or severe diabetes with high infection risk.
  7. 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.
  8. Pregnant, planning to become pregnant, or currently breastfeeding.
  9. Within 3 months post-lumbar spine surgery.
  10. 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.
  11. Difficulty in completing the informed consent process.
  12. Any other condition that the investigator deems inappropriate for participation in the clinical trial.
Terms in these criteria, in plain language(4)

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.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Pharmacopuncture group

    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.

    Procedure: Pharmacopuncture

  • Active comparator
    Physical Therapy Group

    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).

    Procedure: Physical Therapy

Interventions

  • ProcedurePharmacopuncture

    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.

  • ProcedurePhysical Therapy

    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.

06

What researchers measure

Primary outcomes

  1. Leg pain Numeric Rating Scale, NRS

    Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain

    Time frame: Week 7

Secondary outcomes

  1. Leg and low back pain Numeric Rating Scale

    The pain intensity of leg and low back over the past week

    Time frame: Week 1,2,3,4,5,6,7,13

  2. Leg and low back pain Visual Analogue Scale

    The pain intensity of leg and low back over the past week

    Time frame: Week 1,2,3,4,5,6,7

  3. Oswestry Disability Index

    The degree of low back disability in daily life

    Time frame: Week 1,7,13

  4. Roland-Morris Disability Questionnaire

    assesse the functional status of patients with low back pain

    Time frame: Week 1,7,13

  5. Patient Global Impression of Change

    The subject's subjective improvement

    Time frame: Week 7,13

  6. Health-related Quality of Life Instrument with 8 Items

    A tool developed to measure the health-related quality of life in Koreans

    Time frame: Week 1,7,13

  7. 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

    Time frame: Week 1,7,13

  8. Adverse events

    An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.

    Time frame: Week 1,2,3,4,5,6,7,13

07

Study locations

1 of 4 sites recruiting
  • Bucheon Jaseng Hospital of Korean Medicine
    Bucheon-si, Gyeonggi-do, South Korea
    Completed

    Not enrolling at this site.

  • Kyung Hee University Korean Medicine Hospital at Gangdong
    Seongnam-si, Gyeonggi-do, South Korea
    Completed

    Not enrolling at this site.

  • Jaseng Hospital of Korean Medicine
    Seoul, Seoul, South Korea
    Completed

    Not enrolling at this site.

  • Kyung Hee University Korean Medicine Hospital at Gangdong
    Seoul, Seoul, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.

Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 16 months is above that.

Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2025
First posted
Sep 21, 2026
StartActual
Aug 22, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832318
Lead sponsor
Jaseng Medical Foundation
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Aug 22, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 21, 2026

Study contacts

In-Hyuk Ha, Dr
Contact
hanihata@gmail.com
1577-0007
In-Hyuk Ha
study director · Jaseng Medical Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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