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

Inclusion Criteria1

  • Among the patients with lumbar spinal stenosis findings and narrowing of the spinal canal detected by examination and imaging methods, those whose back and leg pain persists for at least 3 months

Exclusion Criteria1

  • Previous lumbar surgery, pregnancy, history of ongoing malignant disease, autoimmune diseases, active infection of the injection site, hematologic disorders, antiplatelet drug use

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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)

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NCT06393959


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