Relief of Lumbar Spinal Stenosis Symptoms

NCT06393959 | Recruiting

• 1 other identifier: Spinal Stenosis
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Stenosis Lumbar; Low Back Pain

Keywords

Pulsed Radiofrequency Treatment; Lomber spinal Stenosis; Caudal epidural steroid injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Medication Quantification Scale III (MQS III)

  Change from baseline to 1st,2nd and 3th month after treatment

Study Arms (2)

pulsed radiofrequency group

ACTIVE COMPARATOR

Caudal epidural pulsed radiofrequency for lumbar spinal stenosis

Procedure: Caudal epidural pulsed radiofrequency

steroid enjection grroup

ACTIVE COMPARATOR

Caudal epidural steroid enjection for lumbar spinal stenosis

Procedure: Caudal epidural steroid enjection

Interventions

Caudal epidural pulsed radiofrequency PROCEDURE

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.

pulsed radiofrequency group

Caudal epidural steroid enjection PROCEDURE

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.

steroid enjection grroup

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (2)

Damla Yürük

Ankara, Türkiye, 5319932, Turkey (Türkiye)

RECRUITING

Ankara Etlik City Hospital

Ankara, Yenimahalle, 5319932, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ömer Taylan T Akkaya, Prof

  Department of Algology, Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damla T Yürük, MD

CONTACT

095319932378; dr.taylanakkaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: February 15, 2024
• Primary Completion: July 19, 2024
• Study Completion: July 20, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

TU (2)