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

A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Lumbar Radiculopathy
• Intervention / Treatment: Procedure: Pharmacopuncture; Procedure: Physical Therapy

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 Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In-Hyuk Ha, Dr; Phone Number: 1577-0007; Email: hanihata@gmail.com

Study Locations

• South Korea
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea
      • Completed
      • Bucheon Jaseng Hospital of Korean Medicine
    • Seongnam-si, Gyeonggi-do, South Korea
      • Completed
      • Kyung Hee University Korean Medicine Hospital at Gangdong
  • Seoul
    • Seoul, Seoul, South Korea
      • Completed
      • Jaseng Hospital of Korean Medicine
    • Seoul, Seoul, South Korea
      • Recruiting
      • Kyung Hee University Korean Medicine Hospital at Gangdong
      • Contact: Byung-Kwan Seo, KMD; Phone Number: 82-10-3431-5193; Email: seohbk@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 informed consent to participate in the clinical trial.

2. Exclusion Criteria:

1. Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis 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 steroids, immunosuppressants, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacopuncture group; 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.; 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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg pain Numeric Rating Scale, NRS	Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain	Week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg and low back pain Numeric Rating Scale	The pain intensity of leg and low back over the past week	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	Week 1,2,3,4,5,6,7
Oswestry Disability Index	The degree of low back disability in daily life	Week 1,7,13
Roland-Morris Disability Questionnaire	assesse the functional status of patients with low back pain	Week 1,7,13
Patient Global Impression of Change	The subject's subjective improvement	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	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	Week 1,7,13
Adverse events	An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.	Week 1,2,3,4,5,6,7,13

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Radiculopathy; Chronic Pain; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: JS-CT-2024-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No