Skip to content

Epidural injection of hyaluronidase in failed back surgery syndrome

Comparison of two doses of hyaluronidase in the outcome of epidural steroid injection in patients with failed back surgery syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240827062876N1
Enrollment
40
Registered
2024-09-05
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Failed back surgery syndrome. Postlaminectomy syndrome, not elsewhere classified

Interventions

Intervention 1: Intervention group: after obtaining consent, qualified people, in the form of random sampling, under aseptic conditions, epidural caudal and transforaminal injection of hyaluronidase 3

Sponsors

Ghoum University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Candidate patients to remove adhesions with medication Age older than 18 years History of epidural steroid injection in the last six months Patients who have not responded satisfactorily to 6 weeks of medical treatment despite the annoying pain NRS>=5 The presence of evidence of pressure on the lumbar spinal cord in MRI

Exclusion criteria

Exclusion criteria: Hyaluronidase contraindications Symptoms of cauda equina, spinal canal stenosis requiring surgery, psychosomatic disease suffering from diabetes; Suffering from rheumatic diseases and vascular collagen and gout and lupus Having nerve damage and neuropathies Suffering from bleeding diseases Inability to communicate History of allergies and allergic reactions to the drugs used History of significant liver, kidney and cardio-pulmonary disorders Pregnancy Suffering from cancers

Design outcomes

Primary

MeasureTime frame
Pain Level. Timepoint: Two weeks, one month, three months and six months after treatment. Method of measurement: Numeric Rating Scale (NRS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).;Disability Level. Timepoint: Two weeks, one month, three months 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Aminnejad

Ghoum University of Medical Sciences

r.aminnejad@yahoo.com+98 25 3612 2000

Outcome results

None listed

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