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Comparison of discogel injection in patients with degenerative disc disease and radicular pain

Comparison of the effect of discogel injection in patients with degenerative disc disease and radicular pain: a single-blind clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210415050983N7
Enrollment
60
Registered
2024-09-17
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Degenerative disc disorders and radicular pains are suitable for discogel injection. Radicular pain is a type of pain that extends from the back and hips through the spine to the legs. The pain follows the spinal nerve root. Degenerative disc disease is a condition in which a damaged disc causes pain. This pain can range from discomfort to disability. This condition can be caused by disc drying over time, daily activities, sports, and injuries..

Interventions

Intervention group: patients with degenerative disc.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: individuals aged 18 to 90 with a history of unilateral or bilateral radicular pain in the lower limb caused by lumbar intervertebral disc herniation, without neurological deficits. This condition was confirmed through physical examination and medical imaging (radiology and magnetic resonance imaging). Additionally, individuals must not have responded to conservative treatment for at least the past 3 months.

Exclusion criteria

Exclusion criteria: disc fragment, segmental instability (spondylolisthesis cis) - Stenosis of neural foramen or spinal canal 3- Asymptomatic protrusion of the intervertebral disc 4- Untreated infection and/or discitis 5- pregnancy 7- Anticoagulant treatment (must be stopped before surgery) 8- Severe degenerative disc disease with more than 2/3 reduction in disc height 9- And having a history of intervertebral disc surgery at the same level

Design outcomes

Primary

MeasureTime frame
The Numerical Rating Scale (NRS) is widely used to measure pain through self-reporting. Its popularity is due to its simplicity - it doesn't require specialized equipment - and the fact that its 0-10 scale is preferred by healthcare professionals. The scale's validity and reliability have already been proven. Patients are typically asked, "On a scale of 0 to 10, how intense has your pain been in the last 14 days? 0 represents no pain, while 10 represents the most severe pain imaginable.". Timepoint: one and three months after injection. Method of measurement: questionnaire.

Secondary

MeasureTime frame
The Disability Index (ODI) is also measured at the specified times, assessing disability with 10 ODI items. Each item is scored from 0-5, with a higher score indicating more disability. If the total score reaches 28, no further treatment will be administered to alleviate the pain. In cases where the Numeric Rating Scale (NRS) score is greater than 4, non-steroidal anti-inflammatory drugs will be used. The success of the treatment in this protocol is determined by the outcomes being classified as average or good, while poor outcomes are considered treatment failures. Timepoint: a month and three months after injection. Method of measurement: questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsogol asgari

Shahid Beheshti University of Medical Sciences

drasgar98429@sbmu.ac.ir+98 21 5541 9005

Outcome results

None listed

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