Relief of Lumbar Spinal Stenosis Symptoms

Not Applicable

Recruiting

• Conditions: Spinal Stenosis Lumbar; Low Back Pain
• Interventions: Procedure: Caudal epidural pulsed radiofrequency; Procedure: Caudal epidural steroid enjection

• Registration Number: NCT06393959
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief 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.

Detailed Description

Low back pain (LBP) is one of the leading causes of disability worldwide. Lumbar spinal stenosis is one of the three most common diagnoses of lower back and leg pain, along with intervertebral disc herniation and degenerative spondylolisthesis. Numerous treatment modalities have been proposed for the management of lumbar spinal stenosis, including drug therapy and complex surgical fusion. Epidural injections are a nonsurgical intervention commonly used in the treatment of spinal stenosis. Saline, local anesthetics, steroids, hylaze, platelet-rich plasma, and pulsed radiofrequency (PRF) administered to the caudal epidural space have been reported to be effective in the treatment of pain.

Among these, caudal epidural PRF has been applied in a limited number of chronic painful conditions (failed back surgery syndrome, chronic distal symmetrical polyneuropathy, postherpetic neuralgia, and coccygodynia), and no randomized controlled studies have been conducted. PRF produces a nonthermal effect that modulates the transmission of pain signals by delivering a short-term high-voltage electric current to the target nerve. RFT provides a continuous current that heats the target tissue and causes coagulation necrosis in nerves.

The primary aim of this study was to compare the efficacy of caudal epidural RFT and caudal epidural steroid injections in patients with lumbar spinal stenosis. The secondary aim was to determine the effects of the interventions on drug consumption and interventional safety, based on adverse events.

A total of at least 50 patients will be enrolled for comparison, with 25 in each group. NRS and MQS III scores will be compared both within and between groups before and 1, 2, and 3 months after treatment.

Study Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-20
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulsed radiofrequency group	Caudal epidural pulsed radiofrequency	Caudal epidural pulsed radiofrequency for lumbar spinal stenosis
steroid enjection grroup	Caudal epidural steroid enjection	Caudal epidural steroid enjection for lumbar spinal stenosis

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	Change from baseline to 1st,2nd and 3th month after treatment	NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcome Measures

Name	Time	Method
The Medication Quantification Scale III (MQS III)	Change from baseline to 1st,2nd and 3th month after treatment	The MQS III is a validated tool in medical research that quantifies medication regimens by assigning a numerical value to each medication based on its class, dosage, and associated risks. This scale aids clinicians and researchers in tracking changes in pain levels throughout a treatment course or study, providing an objective measure of medication consumption and its potential negative impact.

Trial Locations

Locations (2)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Yenimahalle, Turkey

Damla Yürük; 🇹🇷 Ankara, Türkiye, Turkey