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Clinical Research of Comparative Effectiveness of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010341
Enrollment
92
Registered
2025-03-26
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : This study is designed as a comparative effectiveness study, where the treatment group receives pharmacopuncture therapy, while the control group undergoes physical therapy. The sp

Sponsors

Dongguk University Bundang Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Chronic lumbar radiculopathy pain lasting for more than 3 months. ? Presence of at least one sign in one or both lower extremities, including myotomal weakness, dermatomal sensory disturbances(sensory loss, self-reported tingling/numbness), diminished reflexes, or radicular pain exacerbation by straight leg raising test. ? Numeric Rating Scale (NRS) for lower extremity pain of 4/10 or higher. ? Age between 19 and 69 years old. ? Consent to participate in the study and provide a written informed consent form.

Exclusion criteria

Exclusion criteria: ? Diagnosis of red flag conditions causing lower extremity pain (e.g., spinal metastasis, acute fractures, vertebral dislocation). ? Presence of progressive neurological deficits or severe neurological symptoms. ? Pain from soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout). ? Coexisting chronic conditions that may affect treatment outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy). ? Current use of steroids, immunosuppressants, psychiatric medications, or other relevant drugs. ? Ineligibility for pharmacopuncture due to safety concerns (e.g., bleeding disorders, severe diabetes). ? Use of pain-affecting medications (e.g., NSAIDs) or prior pharmacopuncture/acupuncture/physical therapy within the past one week. ? Pregnancy, plans for pregnancy, or breastfeeding. ? Lumbar surgery within the past three months. ? Participants who have not completed involvement in another clinical trial within the last month, or who plan to engage in a new trial during the study participation and follow-up period within six months. ? Difficulty completing the informed consent form. ? Other conditions judged by the researcher as hard to manage for study participation

Design outcomes

Primary

MeasureTime frame
Numeric Rating Scale (NRS) for Lower Extremity Pain

Secondary

MeasureTime frame
Numeric Rating Scale (NRS) for Low Back Pain;Visual Analogue Scale (VAS) for Lower Extremity Pain;Visual Analogue Scale (VAS) for Low Back Pain ;Oswestry Disability Index (ODI);Roland-Morris Disability Questionnaire (RMDQ);Patient Global Impression of Change (PGIC);Health-related Quality of Life Instrument with 8 Items (HINT-8);5-Level EuroQol-5 Dimension (EQ-5D-5L);Credibility and Expectancy;Work Productivity and Activity Impairment questionnaire (WAPI);Comedication Consumption;Adverse events;Blood test result

Countries

Korea, Republic of

Contacts

Public ContactGaYoung Kim

Dongguk University Bundang Oriental Hospital

kgyhani@gmail.com+82-31-710-3751

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026