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Epidural injection of Dexamethasone palmitate vs. betamethasone for lumbar disk herniation, a multi-center non-inferiority randomized double blind controlled trial

Epidural injection of Dexamethasone palmitate vs. betamethasone for lumbar disk herniation, a non-inferiority randomized double blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093970
Enrollment
Unknown
Registered
2024-12-15
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Lumbar disc herniation

Interventions

Dexamethasone palmitate:According to the patients symptoms, signs and imaging findings, the affected nerve root was selected for epidural injection through the intervertebral foramen or lamina space.
Control group:Compound betamethasone

Sponsors

The First Affiliate Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1)Age =18 years old; 2) unilateral pain in the buttock or below, with or without lumbago. 3) Lower limb pain is greater than low back pain, and NRS score =4. 4) Lumbar MRI or CT within 6 months confirmed the presence of lumbar disc herniation,

Exclusion criteria

Exclusion criteria: 1)Individuals allergic to the study drug. 2)Patients with a history of mental illness. 3)Patients who are unable to understand the study content, cannot cooperate with completing the questionnaires, or are unable to follow up. 4)Patients with concomitant diseases that may interfere with the assessment of efficacy (primarily conditions that may cause lower limb pain, such as Parkinson's disease, diabetic peripheral neuropathy, lower limb thrombosis, etc.). 5)Severe cardiovascular diseases that affect daily activities and interfere with functional assessments. 6)Unstable spondylolisthesis (vertebral displacement > 3mm or endplate angle change > 15° on dynamic lumbar X-rays), or grade III and above stable spondylolisthesis. 7)Severe osteoporosis with vertebral compression fractures in the segments intended for injection treatment. 8)Malignant tumors with spinal metastases. 9)Pregnant women, breastfeeding women, women planning pregnancy in the near future, or spouses planning pregnancy soon. 10)Other contraindications for injection therapy, such as infection at the puncture site, severe coagulopathy (e.g., gum bleeding), etc. 11)Having undergone an epidural injection in the past 3 months. 12)Patients with surgical plans within 3 months. 13)Platelet count less than 50 × 10?/L or those currently using anticoagulants or antiplatelet medications. 14)Patients with any of the following comorbidities: posterior capsule cataract, glaucoma, herpes simplex keratitis, poorly controlled diabetes (fasting blood glucose =7 mmol/L), recent acute myocardial infarction, peptic ulcers, tuberculosis, untreated infectious diseases, systemic fungal infections, electrolyte disturbances, recent abdominal surgery, or thrombotic conditions.

Design outcomes

Primary

MeasureTime frame
pain intensity;

Secondary

MeasureTime frame
ODI score;Disability;Anxiety;depression;

Countries

china

Contacts

Public Contactjinxiaohong

The First Affiliate Hospital of Soochow University

jxhtgzy@163.com+86 183 5240 9837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 20, 2026