Ultrasound‑Guided versus Fluoroscopy‑Guided Transforaminal Epidural Steroid Injection for Refractory Lumbar Disc Prolapse with Radiculopathy: a Randomised Controlled Trial
Abstract
Background: Chronic lumbar radiculopathy is a widespread, disabling type of low back pain affecting 3-5 % of the population. Transforaminal epidural steroid injection (TFESI) is an effective method of delivering anti-inflammatories to a specific area in patients who have not benefited from conservative treatment. The standard TFESI is done under fluoroscopic control, but involves exposure to ionising radiation for both the patient and the staff. Under ultrasound guidance, soft tissue can be visualised in real-time and without the use of radiation, and may reduce procedure time. There is little evidence that compares the two modalities in low and middle-income settings.
The hypothesis was that ultrasound‑guided TFESI is as effective and safe as fluoroscopy‑guided TFESI in adults with recalcitrant lumbar disc prolapse and radiculopathy. Hypothesis: TFESI under ultrasound guidance is as successful and safe as fluoroscopy guidance in adults with refractory lumbar disc prolapse and radiculopathy. The main hypothesis was that ultrasound guidance would be effective in relieving pain and would reduce the time required to complete the procedure.
Methods: A single‑blinded randomised controlled trial was performed in the Department of Radiology, Mayo Hospital in Lahore. In this prospective study, 60 refractory patients with lumbar disc prolapse and unilateral radicular pain were randomised into ultrasound-guided group (n = 30) and fluoroscopy-guided group (n = 30) for TFESI. The intervention consisted of an interforaminal injection of a 22-gauge needle under imaging control and injection of methylprednisolone and local anaesthetic. The primary outcomes were the duration of the procedure and the severity of pain on the Numeric Pain Rating Scale (NPRS) at baseline, 2, and 1 weeks. Other secondary variables were age, sex, and residential status. A t-test, a chi-square test, and a stratified analysis were used to analyse the data. A p‑value ≤ 0.05 was considered significant.
Results: No significant difference was seen between groups with respect to baseline characteristics (mean age 47.37±14.56 years; 53.3 % males). The ultrasound group had significantly shorter mean procedure time (7.07±1.11 min) than the fluoroscopy group (11.13±1.04 min; p < 0.001). Baseline pain scores were comparable (8.63±0.55 vs. 8.70±0.59; p = 0.656). At 2 weeks, pain scores were lower in the ultrasound group (6.67±0.76 vs. 7.17±0.65; p = 0.008). The ultrasound group did have slightly more pain reduction than the other group (4.07±1.17 vs. 4.63±1.22), although the difference was not statistically significant (p = 0.071) at 1 month.
Conclusions: Ultrasound‑guided TFESI was shown to be comparable in terms of analgesia but significantly reduced procedure time when compared with fluoroscopy‑guided TFESI. In the absence of radiation and other similar clinical results, ultrasound guidance is a safe and effective alternative for refractory lumbar radiculopathy. Larger multicentre trials with a longer follow-up are warranted.
