Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07771374
This study aims to compare the effects of different ultrasound-guided periradicular injection solutions in patients with chronic unilateral radicular pain caused by a single-level lumbar disc herniation.
Participants receive an ultrasound-guided periradicular injection containing lidocaine and dexamethasone, either alone or combined with 5% dextrose or 0.9% sodium chloride. The study evaluates whether adding dextrose or sodium chloride provides additional benefit in reducing pain and improving function and quality of life.
Pain intensity, disability, quality of life, and analgesic use are assessed before treatment and during follow-up. The main hypothesis is that the addition of 5% dextrose or 0.9% sodium chloride may improve the clinical effectiveness of the injection compared with lidocaine and dexamethasone alone.
This study is active but is not currently recruiting participants.
Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
The aim of this study is to evaluate whether the addition of 5% dextrose or 0.9% sodium chloride to a corticosteroid and local anesthetic solution provides additional benefit in patients with unilateral radicular pain due to single-level lumbar disc herniation. The study also evaluates whether these solutions may facilitate separation of the disc material and surrounding soft tissues from the affected nerve root and whether dextrose provides an additional analgesic effect in relieving radicular pain.
The study was designed as a randomized, controlled, prospective, single-blind clinical trial. A total of 33 patients aged 25-65 years with chronic low back pain resistant to conservative treatment and unilateral radicular leg pain, with single-level lumbar disc herniation confirmed by physical examination and magnetic resonance imaging, were included.
Participants were assigned to treatment groups according to a computer-generated randomization scheme. With n = 11 participants in each group, the first group received a total of 3 mL consisting of 1 mL of 0.2% lidocaine hydrochloride and 8 mg/2 mL of dexamethasone. The second group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 5% dextrose. The third group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 0.9% sodium chloride solution.
Participants were unaware of their assigned treatment group. In all participants, injections were administered under sterile conditions in the outpatient interventional procedure room with the participant in the prone position. All procedures were performed under ultrasound guidance using a 1-5 MHz convex probe as a single-session, unilateral, single-level periradicular injection.
Participants were evaluated at four time points: before the injection, 1 hour after the injection, and during face-to-face follow-up visits at 1 and 3 months. The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcome measures included the Oswestry Disability Index (ODI), the Short Form-36, and the amount of analgesic use.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 mL of lidocaine hydrochloride 20 mg/mL (2%) injection solution was administered as a component of the ultrasound-guided periradicular injection.
Other names: Jetokain Simplex 20 mg/mL
2 mL of dexamethasone 4 mg/mL injection solution (total dose: 8 mg) was administered as a component of the ultrasound-guided periradicular injection.
Other names: Dekort 8 mg/2 mL
7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection.
Other names: POLİFLEKS 5% Dextrose 100 mL
7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection.
Other names: POLİFLEKS 0.9% Sodium Chloride 100 mL Solution for Infusion
Time frame: Baseline, 1 hour, 1 month, and 3 months after the intervention
Leg pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in VAS score from baseline will be evaluated at 1 hour, 1 month, and 3 months after the intervention.
Time frame: Baseline, 1 hour, 1 month, and 3 months after the intervention
Low back pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in VAS score from baseline will be evaluated at 1 hour, 1 month, and 3 months after the intervention.
Time frame: Baseline, 1 month, and 3 months after the intervention
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections, each scored from 0 to 5, with a total raw score ranging from 0 to 50. The total score is converted to a percentage, ranging from 0% to 100%, where higher scores indicate greater disability. The change in ODI score from baseline will be evaluated during follow-up.
Time frame: Baseline, 1 month, and 3 months after the intervention
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Changes in SF-36 domain scores from baseline will be evaluated during follow-up.
Time frame: Baseline, 1 month, and 3 months after the intervention
Analgesic medication use during the previous month will be recorded as the number of days of analgesic use multiplied by the number of analgesic doses taken per day (days × doses). Changes in analgesic medication use from baseline will be evaluated during follow-up.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Other
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