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

Comparison of hyaluronidase Vs. hypertonic saline 5% effects in Percutaneous Caudal Epidural Adhesiolysis With the Racz Technique for patients with Failed Back Surgery Syndrome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131124015515N7

Enrollment

Registered

2019-07-28

Start date

2019-07-31

Completion date

Unknown

Last updated

2019-10-07

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 placing the Racz catheter under fluorescope and determining the location of the lesion, 10-20 ml of saline solution with 1500 IU of hyaluronidase, 0.25% of bu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Hashemi MD.

Shahid Beheshti University of Medical Sciences

dr.hashemi@sbmu.ac.ir+98 21 2261 2252

Outcome results

None listed

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