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Comparing the efficacy of transforaminal epidural steroid combined hyaluronic acid versus steroid combined hyaluronidase injection in improvement of function and pain related to lumbosacral disk herniation, A Randomized Clinical Trial

Comparing the efficacy of transforaminal epidural steroid combined hyaluronic acid versus steroid combined hyaluronidase injection in improvement of function and pain related to lumbosacral disk herniation, A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130523013442N39
Enrollment
34
Registered
2026-05-11
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

lumbar disc herniation and lumbar spinal stenosis.

Interventions

Intervention group: steroid-hyaluronic-acid, control group:steroid-hyaluronidase.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: patients aged 20 to 65 years with a BMI <33 with radicular back pain of lumbar disc origin that has not responded to conservative treatments within 6 weeks of treatment. Positive MRI findings of intervertebral disc herniation and canal stenosis or intervertebral foramen stenosis and positive clinical tests in favor of intervertebral disc involvement and lumbar root involvement in EMG/NCS

Exclusion criteria

Exclusion criteria: Neurological deficits such as muscle weakness or symptoms of cauda equina syndrome, multi-root and bilateral involvement, bone stenosis and stenosis due to ligamentous hypertrophy, history of back surgery, vascular problems of the lower extremities and vascular claudication, history of lower extremities surgery, unstable hemodynamic conditions, sensitivity to drugs used in the study, use of corticosteroids (last 2 weeks), presence of coagulation disorders or uncontrolled systemic problems, uncontrolled diabetes, uncontrolled blood pressure, presence of systemic infection or infection at the injection site, pregnancy, presence of neurological diseases such as MS.

Design outcomes

Primary

MeasureTime frame
. Timepoint: . Method of measurement: .;Pain and function. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the intervention. Method of measurement: Pain assessment with visual analog scale, function assessment with Roland-Morris questionnaire and Oswestry Disability Index.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactseyed Ahmad Raeissadat

Shahid Beheshti University of Medical Sciences

ahmad_raeissadat@yahoo.com+98 21 2236 0635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026