Clinical Research Directory

Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain

The aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) with a radicular component for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success

Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood. This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.

R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

The R³ trial is a multicentre cluster randomized controlled trial evaluating an evidence-based, person-centred rehabilitation pathway for patients undergoing lumbar surgery for radicular pain. The pathway includes structured pre-, peri-, and postoperative rehabilitation, early postoperative mobilization, case management, early return-to-work (RTW) guidance, and patient empowerment. Clusters (hospitals) are randomized to implement the R³ pathway (intervention) or continue usual care (control). The primary aim is to determine whether the R³ pathway reduces time to return to work compared with usual care.