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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: In-Hyuk Ha, Dr
- Telefonnummer: 1577-0007
- E-Mail: hanihata@gmail.com
Studienorte
-
-
Gyeonggi-do
-
Bucheon-si, Gyeonggi-do, Südkorea
- Abgeschlossen
- Bucheon Jaseng Hospital of Korean Medicine
-
Seongnam-si, Gyeonggi-do, Südkorea
- Abgeschlossen
- Kyung Hee University Korean Medicine Hospital at Gangdong
-
-
Seoul
-
Seoul, Seoul, Südkorea
- Abgeschlossen
- Jaseng Hospital of Korean Medicine
-
Seoul, Seoul, Südkorea
- Rekrutierung
- Kyung Hee University Korean Medicine Hospital at Gangdong
-
Kontakt:
- Byung-Kwan Seo, KMD
- Telefonnummer: 82-10-3431-5193
- E-Mail: seohbk@hanmail.net
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Leg pain Numeric Rating Scale, NRS
Zeitfenster: Week 7
|
Change from baseline to Week 7 on the Numeric Rating Scale of Leg pain |
Week 7
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Leg and low back pain Numeric Rating Scale
Zeitfenster: 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
|
|
Leg and low back pain Visual Analogue Scale
Zeitfenster: 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
|
|
Oswestry Disability Index
Zeitfenster: Week 1,7,13
|
The degree of low back disability in daily life |
Week 1,7,13
|
|
Roland-Morris Disability Questionnaire
Zeitfenster: Week 1,7,13
|
assesse the functional status of patients with low back pain |
Week 1,7,13
|
|
Patient Global Impression of Change
Zeitfenster: Week 7,13
|
The subject's subjective improvement |
Week 7,13
|
|
Health-related Quality of Life Instrument with 8 Items
Zeitfenster: Week 1,7,13
|
A tool developed to measure the health-related quality of life in Koreans |
Week 1,7,13
|
|
5-Level EuroQol-5 Dimension
Zeitfenster: Week 1,7,13
|
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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: In-Hyuk Ha, Jaseng Medical Foundation
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JS-CT-2024-10
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .