A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
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.
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.
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do, South Korea
COMPLETEDKyung Hee University Korean Medicine Hospital at Gangdong
Seongnam-si, Gyeonggi-do, South Korea
COMPLETEDJaseng Hospital of Korean Medicine
Seoul, Seoul, South Korea
COMPLETEDLeg pain Numeric Rating Scale, NRS
Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain
Time frame: Week 7
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
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
Oswestry Disability Index
The degree of low back disability in daily life
Time frame: Week 1,7,13
Roland-Morris Disability Questionnaire
assesse the functional status of patients with low back pain
Time frame: Week 1,7,13
Patient Global Impression of Change
The subject's subjective improvement
Time frame: 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
Time frame: 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
Time frame: Week 1,7,13
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Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Seoul, South Korea
RECRUITINGAdverse 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