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

Phase 3

Recruiting

Conditions: piriformis muscle syndrome.
Injury of sciatic nerve at hip and thigh level
S74.0

Registration Number: IRCT20191213045717N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures