Lumbar Radiculopathy, Chronic Pain
Conditions
Brief summary
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.
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.
Sponsors
Jaseng Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leg pain Numeric Rating Scale, NRS | Week 7 | Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leg and low back pain Numeric Rating Scale | Week 1,2,3,4,5,6,7,13 | The pain intensity of leg and low back over the past week |
| Leg and low back pain Visual Analogue Scale | Week 1,2,3,4,5,6,7 | The pain intensity of leg and low back over the past week |
| Oswestry Disability Index | Week 1,7,13 | The degree of low back disability in daily life |
| Roland-Morris Disability Questionnaire | Week 1,7,13 | assesse the functional status of patients with low back pain |
| Patient Global Impression of Change | Week 7,13 | The subject's subjective improvement |
| Health-related Quality of Life Instrument with 8 Items | Week 1,7,13 | A tool developed to measure the health-related quality of life in Koreans |
| 5-Level EuroQol-5 Dimension | Week 1,7,13 | A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression |
| Adverse events | Week 1,2,3,4,5,6,7,13 | An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study. |
Countries
South Korea
Contacts
CONTACTIn-Hyuk Ha, Dr
STUDY_DIRECTORIn-Hyuk Ha
Jaseng Medical Foundation
Outcome results
None listed