Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorAssiut University

About this trial

Evaluating the superiority of caudal neuroplasty using epidural catheter (Perifix® Complete Set 16 G) combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbar radicular pain on pain reduction and quality of life within six months follow up.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients aged 20-80 years old complaining with lumbosacral radicular pain.

pain intensity ≥4 out of 10 on the numerical rating scale (NRS).

dominant leg pain with less intense back pain.

previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.

Disqualifiers

patient refusal to participate in the study,

age <20 years,

unbearable pain >9-points on NRS, pain <4-points on NRS.

signs of progressive motor weakness or neurologic deficits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • f caudal neuroplasty using epidural catheter combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone

    Procedure/Surgery

    Fluoroscopic guidance was used in all cases with a C-arm system. The patient was prone with a pillow under the lower abdomen. Anteroposterior (AP) images were taken to identify the target level. The C-arm was angled 15-30° to project the spinous process over the contralateral facet ("scotty dog" view). Skin was infiltrated with lidocaine, and a 22-gauge RF cannula was advanced under fluoroscopy. The tip was positioned in the dorsal-cranial quadrant of the intervertebral foramen on lateral images. PRF was applied with 4 cycles at 42°C for 8 minutes after sensory/motor testing. Injections of lidocaine and triamcinolone followed. In caudal neuroplasty, an epidural catheter was placed using the sacral hiatus as a guide. Fluoroscopy confirmed catheter position. Contrast was injected to confirm spread, and hyaluronidase and lidocaine were administered. Afterward, the catheter was removed.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: GROUP AExperimental treatment 1 intervention
Group B: GROUP BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

improvement in pain intensity using VAS score

The most effective modality in reducing the intensity of pain in patients with lumbar radicular pain

Time frame
baseline

Secondary outcomes

1

duration of analgesic effect

Duration of the analgesic effect following RF procedures

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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