Chronic Unilateral Lumbar Radicular Pain

Ain Shams University

Status: Enrolling

Conditions: Neuropathic Pain

Treatments: Other: Interlaminar technique (IL); Other: Transgrade technique (TG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06092749

FMASU MD 286/ 2023

Details and patient eligibility

About

Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 6-month history of persistent pain in one leg with back pain.
• Capable of giving informed consent.
• Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.

Exclusion criteria

• Previous lumbar spinal surgery.
• Myelopathy.
• Rheumatoid disorders.
• Psychiatric disorders
• Bleeding or coagulation disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Transgrade technique (TG)

Active Comparator group

Treatment:

Other: Transgrade technique (TG)

Interlaminar technique (IL)

Active Comparator group

Treatment:

Other: Interlaminar technique (IL)