RecruitingNot ApplicableNCT06393959

Relief of Lumbar Spinal Stenosis Symptoms

Comparison of Pulsed Radiofrequency Stimulation Versus Dexamethasone Applied to the Caudal Epidural Space for the Relief of Lumbar Spinal Stenosis Symptoms


Sponsor

Diskapi Teaching and Research Hospital

Enrollment

50 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis. This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Caudal epidural pulsed radiofrequency and a procedure called Caudal epidural steroid enjection for people with low back pain and spinal stenosis lumbar. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURECaudal epidural pulsed radiofrequency

The patient lied in prone position. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a 22- gauge 150-mm RF cannula with 20 mm active tip was advanced through the sacrococcygeal ligament into the caudal epidural space under floroscopic guidence. A few milliliters contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, an electrode was connected to the cannula, and stimulation was conducted with impedance measured between 250 and 350 Ohms A different sensation or feeling such as fullness, impression, tingling, pulling or plethora at the rectal and/or coccygeal region was observed by the patients when 50 Hz was applied with 0,4 to 0,7 V sensory stimulation. No leg muscle contraction was observed with 2 Hz motor stimulation at 2 V. PRF was performed for 600 s at 5 Hz using a 5-ms pulse width at 55 V, avoiding electrode tip temperatures above 42 C.

PROCEDURECaudal epidural steroid enjection

The patient lied in prone position and aseptic techniques were adopted. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a spinal needle was advanced through the sacrococcygeal ligament into the caudal epidural space under fluoroscopic guidance. The needle tip was confirmed by negative aspiration for blood or cerebrospinal fluid, then a few milliliters of contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, a total of 10 ml mixture of saline and 8 mg dexametzone was administered into the epidural space.


Locations(2)

Damla Yürük

Ankara, Türkiye, Turkey (Türkiye)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06393959


Related Trials