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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: In-Hyuk Ha, Dr
- Telefonní číslo: 1577-0007
- E-mail: hanihata@gmail.com
Studijní místa
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Jižní Korea
- Dokončeno
- Bucheon Jaseng Hospital of Korean Medicine
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Seongnam-si, Gyeonggi-do, Jižní Korea
- Dokončeno
- Kyung Hee University Korean Medicine Hospital at Gangdong
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Seoul
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Seoul, Seoul, Jižní Korea
- Dokončeno
- Jaseng Hospital of Korean Medicine
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Seoul, Seoul, Jižní Korea
- Nábor
- Kyung Hee University Korean Medicine Hospital at Gangdong
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Kontakt:
- Byung-Kwan Seo, KMD
- Telefonní číslo: 82-10-3431-5193
- E-mail: seohbk@hanmail.net
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
1. Inclusion Criteria:
- Persistent sciatica symptoms lasting for more than 3 months.
- 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
- Numeric Rating Scale (NRS) score of 4 or higher for leg pain.
- Aged between 19 and 70 years.
- Provided written informed consent to participate in the clinical trial.
2. Exclusion Criteria:
- Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis of cancer, acute vertebral fracture, or dislocation).
- Presence of progressive neurological deficits or severe neurological symptoms.
- Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
- Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).
- Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
- Inappropriate or unsafe conditions for pharmacopuncture, including bleeding disorders, anticoagulant therapy, or severe diabetes with high infection risk.
- 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.
- Pregnant, planning to become pregnant, or currently breastfeeding.
- Within 3 months post-lumbar spine surgery.
- 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.
- Difficulty in completing the informed consent process.
- Any other condition that the investigator deems inappropriate for participation in the clinical trial.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Pharmacopuncture group
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. |
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. |
|
Aktivní komparátor: 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). |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Leg pain Numeric Rating Scale, NRS
Časové okno: Week 7
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Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain |
Week 7
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Leg and low back pain Numeric Rating Scale
Časové okno: Week 1,2,3,4,5,6,7,13
|
The pain intensity of leg and low back over the past week |
Week 1,2,3,4,5,6,7,13
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Leg and low back pain Visual Analogue Scale
Časové okno: Week 1,2,3,4,5,6,7
|
The pain intensity of leg and low back over the past week |
Week 1,2,3,4,5,6,7
|
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Oswestry Disability Index
Časové okno: Week 1,7,13
|
The degree of low back disability in daily life |
Week 1,7,13
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Roland-Morris Disability Questionnaire
Časové okno: Week 1,7,13
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assesse the functional status of patients with low back pain |
Week 1,7,13
|
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Patient Global Impression of Change
Časové okno: Week 7,13
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The subject's subjective improvement |
Week 7,13
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Health-related Quality of Life Instrument with 8 Items
Časové okno: Week 1,7,13
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A tool developed to measure the health-related quality of life in Koreans |
Week 1,7,13
|
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5-Level EuroQol-5 Dimension
Časové okno: Week 1,7,13
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A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression |
Week 1,7,13
|
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Adverse events
Časové okno: 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. |
Week 1,2,3,4,5,6,7,13
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: In-Hyuk Ha, Jaseng Medical Foundation
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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