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Effect of Botulinum Toxin Type A and Methylprednisolone in treatment of Piriformis Syndrome

Comparative Trial of Botulinum Toxin Type A and Methylprednisolone for The Treatment of Piriformis Syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191213045717N1
Enrollment
30
Registered
2020-02-19
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

piriformis muscle syndrome. Injury of sciatic nerve at hip and thigh level

Interventions

Intervention 1: Intervention group: 150 U of botulinum toxin type A (Dysport 50-U/ml solution from Daryan Salamat Pharma Group) in 3 ml of normal saline using 22 gauge LP(Lumbar Puncture) needle under

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: The patients age : 20 years or older Screening of patients for clinically significant Lumbar disk herniation or Lumbosacral radiculopathy by Magnetic Resonance Imaging Trigger point and tenderness in their Gluteal area Pain in their buttocks radiating toward their thigh or lower limb and increasing with prolonged sitting and walking and during bending Increased pain through passive forced hip flexion, adduction, and internal rotation (FAIR position), and pain when the leg was flexed at the knee and the hip was passively and medially rotated (Freiberg test) Having pain for more than 3 months despite the conservative treatment and those whose individual minimum pain severity scores will be greater than 5 on a 10-point numeric rating scale (VAS criteria)

Exclusion criteria

Exclusion criteria: Known allergy or sensitivity to botulinum toxin type A Previous use of botulinum toxin type A or B Current or planned pregnancy Disorders affecting the Neuromuscular junction or Motor neuron disease,Neurologic deficits found during Electromyelography Administration of Amino- Glycosides or other drugs that interfere with Neuromuscular transmission Previous Micro- surgery or Macro-surgery for disc disease, and any Epidural block within 7 weeks of enrollment

Design outcomes

Primary

MeasureTime frame
The severity of Pain. Timepoint: Before treatment, 1th ,4th,8th &12th weeks after the end of treatment. Method of measurement: Visual Analog Scale (VAS).;Quality of life. Timepoint: Before treatment,4th week after the end of treatment. Method of measurement: 36-Item Short Form Health Survey (SF-36).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeynab Shahabi

Iran University of Medical Sciences

zeynab.shahabi@gmail.com+98 21 8214 1229

Outcome results

None listed

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