Chronic Unilateral Lumbar Radicular Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 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.

Disqualifiers

Previous lumbar spinal surgery.

Myelopathy.

Rheumatoid disorders.

Psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transgrade technique (TG)

    Other intervention

    Transgrade (TG) Epidural Steroid Injection technique

  • Interlaminar technique (IL)

    Other intervention

    Interlaminar (IL) Epidural Steroid Injection technique

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Transgrade technique (TG)Active comparator 1 intervention
Group B: Interlaminar technique (IL)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients who experienced successful pain relief at 3 month post-intervention

Number of patients who experienced successful pain relief at 3 month post-intervention, which is defined as ≥ 50% reduction of numeric rating scale (NRS-11) from pre-intervention level.

Time frame
6 month post intervention (study period)

Secondary outcomes

Other outcomes

Sponsors and contacts

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