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Pilot Study Comparing the Efficacy of Gluteal Muscle Injection and Transforaminal Epidural Steroid Injection for the Treatment of Sciatica: A Randomized, Blinded, Controlled Interventional Trial

Pilot Study Comparing the Efficacy of Gluteal Muscle Injection and Transforaminal Epidural Steroid Injection for the Treatment of Sciatica: A Randomized, Blinded, Controlled Interventional Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110190
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Sciatica

Interventions

Group A:Under ultrasound guidance, gluteus maximus injection (betamethasone 5 mg + normal saline 1 ml) + transforaminal epidural injection (normal saline 2 ml)
Group B:Transforaminal epidural injection (betamethasone 5 mg + normal saline 1 ml) + ultrasound-guided gluteus maximus injection (normal saline 2 ml)

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with sciatica, which is confirmed by magnetic resonance imaging (MRI) to be caused by lumbar intervertebral disc herniation compressing the sciatic nerve; 2. Aged between 18 and 70 years old; 3. The duration of symptoms is between 6 weeks and 12 months; 4. Ineffective after at least 6 weeks of conservative and non-invasive treatment; 5. The patient is willing and able to give consent, including but not limited to: drug treatment, physical therapy, and adjustment of daily activities.

Exclusion criteria

Exclusion criteria: 1. Severe neurological deficits (such as foot drop/cauda equina syndrome, etc.); 2. Previous spinal surgery for the same intervertebral disc (segment); 3. Sciatic nerve pain symptoms lasting for more than 12 months; 4. Age 70 years old; 5. Receiving any corticosteroid treatment within the last month before study enrollment; 6. Patients with any contraindications to the drugs involved in the study; 7. More than two symptomatic segments with unilateral imaging abnormalities; 8. Known pregnancy of the patient.

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index of low back;

Secondary

MeasureTime frame
VAS scores for lower limb and low back pain;EQ-5D-5L score;MacNab score;

Countries

China

Contacts

Public ContactFangcai Li

The Second Affiliated Hospital Zhejiang University School of Medicine

liangchengzhen@zju.edu.cn+86 138 5714 4236

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026