Relief of Lumbar Spinal Stenosis Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorDiskapi Teaching and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Caudal epidural pulsed radiofrequency
Procedure/SurgeryThe 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.
Caudal epidural steroid enjection
Procedure/SurgeryThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: pulsed radiofrequency groupActive comparator 1 intervention
Group B: steroid enjection grroupActive comparator 1 intervention
Trial outcomes
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)
Time frame
Change from baseline to 1st,2nd and 3th month after treatmentSecondary outcomes
1
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.
Time frame
Change from baseline to 1st,2nd and 3th month after treatmentSponsors and contacts
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Source ClinicalTrials.gov