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Comparison of the Effect of Hyaluronidase and Hypertonic Saline 5% on Removal lumbar spinal space adhesio

Phase 2
Recruiting
Conditions
Failed Back Surgery Syndrome.
Postlaminectomy syndrome, not elsewhere classified
M96.1
Registration Number
IRCT20131124015515N7
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Age 18 and above
Epidural Adhesion Detection Based on Clinical and MRI Findings
History of spinal surgery
History of chronic low back pain after surgery for more than six months
Radicular or axial back pain
Herniated disk
Patients with satisfaction to participate in the study

Exclusion Criteria

Facet joint arthritis
History of epidural injection or other invasive treatments in the last six months
Severe central lumbar canal stenosis
Stenosis caused by scoliosis
Lumbar disc degenerative
Sacroiliac joint disease
Severe cardiopulmonary disease, uncontrolled diabetes, obesity
History of misuse of any type of narcotic, opioid and alcohol
Pregnancy, breastfeeding
Psychiatric problems and patient's lack of cooperation, speech problems
Surgical indication
Topical skin infections in the area of the surgery
Coagulation disorder
Contraindication for Epidural Lumbar Injection
Patients dissatisfied with participation in the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain Level. Timepoint: Before treatment, one, three and six months after treatment. Method of measurement: visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).;Disability Level. Timepoint: Before treatment, one, three and six months after treatment. Method of measurement: Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.
Secondary Outcome Measures
NameTimeMethod
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