Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06393959 |
Other study ID # |
Spinal Stenosis |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2024 |
Est. completion date |
April 26, 2024 |
Study information
Verified date |
April 2024 |
Source |
Diskapi Teaching and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.