Lumbar Disc Herniation With Radiculopathy
Conditions
Keywords
Radiculopathy, Disc Herniation, Ultrasonographic Imaging, Dexamethasone, Spinal Injections
Brief summary
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.
Detailed description
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.
Interventions
1 mL of lidocaine hydrochloride 20 mg/mL (2%) injection solution was administered as a component of the ultrasound-guided periradicular injection.
2 mL of dexamethasone 4 mg/mL injection solution (total dose: 8 mg) was administered as a component of the ultrasound-guided periradicular injection.
7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection.
7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection.
Sponsors
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were unaware of the assigned injection solution.
Intervention model description
Three parallel groups receive different ultrasound-guided periradicular injection solutions and are followed for 3 months.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 25 and 65 years * Persistent low back and leg pain despite conservative treatment * Unilateral radicular pain accompanying chronic low back pain lasting longer than 3 months * Single-level lumbar disc herniation (LDH) confirmed by clinical evaluation and magnetic resonance imaging (MRI) * Low back pain and unilateral radicular leg pain with a Visual Analog Scale (VAS) score ≥4 * Provision of written informed consent to participate in the study
Exclusion criteria
* Lumbar epidural steroid injection within the previous 6 months or a history of major trauma * History of allergy to any of the medications to be administered * Body mass index (BMI) \>30 kg/m² * Unstable chronic medical disease, such as diabetes mellitus, hypertension, or heart failure * History of lumbar spine surgery * History of coagulopathy * History of malignancy * History of polyneuropathy * History of peripheral vascular disease * Presence of a psychiatric disorder or cognitive impairment that would prevent completion of questionnaires and assessment scales, including dementia or significant visual or hearing impairment * Local infection at the injection site or systemic infection * Pregnancy and/or breastfeeding * Neurological deficit in the lower extremities * Unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Leg Pain Intensity Assessed by Visual Analog Scale (VAS) | 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. |
| Change in Low Back Pain Intensity Assessed by Visual Analog Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability Assessed by the Oswestry Disability Index (ODI) | 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. |
| Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36) | 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. |
| Change in Analgesic Medication Use | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed