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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Spinal Stenosis Lumbar
• Intervention / Treatment: Procedure: Caudal epidural pulsed radiofrequency; Procedure: Caudal epidural steroid enjection

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damla T Yürük, MD; Phone Number: 095319932378; Email: dr.taylanakkaya@gmail.com

Study Locations

• Turkey
  • Türkiye
    • Ankara, Türkiye, Turkey, 5319932
      • Recruiting
      • Damla Yürük
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 5319932
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: DAMLA YÜRÜK; Phone Number: 095319932378; Email: damlayuruk@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pulsed radiofrequency group; Caudal epidural pulsed radiofrequency for lumbar spinal stenosis	Procedure: Caudal 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.
Active Comparator: steroid enjection grroup; Caudal epidural steroid enjection for lumbar spinal stenosis	Procedure: Caudal 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Medication Quantification Scale III (MQS III)	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.	Change from baseline to 1st,2nd and 3th month after treatment

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Ömer Taylan T Akkaya, Prof, Department of Algology, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): July 19, 2024
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pulsed Radiofrequency Treatment; Lomber spinal Stenosis; Caudal epidural steroid injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Spinal Stenosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No