Evaluation of Fluoroscopically Guided Transforaminal Selective Nerve Root Sleeve Injections for Lumbar Spinal Stenosis With Radiculopathy Utilizing Patient Reported Outcome Measurement Information System as an Outcome Measure.

OBJECTIVE: To evaluate the therapeutic effect of transforaminal selective nerve root sleeve injections (TFSNRIs) in a specific subset of patients with clinical symptoms and presentation consistent with spinal stenosis. DESIGN: Retrospective review. SETTING: Tertiary academic spine center. PARTICIPANTS: A total of 176 patients with radicular leg pain with or without low back pain as well as ≥3 clinical features of spinal stenosis and corroborative radiographic features of spinal stenosis on lumbar spine magnetic resonance imaging without confounding spinal pathology (N=176). INTERVENTIONS: Fluoroscopically guided transforaminal selective nerve root sleeve injections. MAIN OUTCOME MEASURES: Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) v1.2/v2.0, Pain Interference (PI) v1.1, and PROMIS (D) v1.0 were collected at baseline and post-procedure short term (<3-months) and long-term (6-12 month) follow-up. Statistical analysis comparing baseline and postprocedural PROMIS scores was performed. Differences were compared with previously established minimal clinically important differences in the spine population. RESULTS: For patients with spinal stenosis treated with TFSNRI, no statistically significant improvement was observed short- and long-term follow-up in PROMIS PF (P=.97, .77) and PROMIS Depression (P=.86, .85) scores. At short-term follow-up, PROMIS PI scores did significantly improve (P=.01) but the average difference of pre- and post-procedure scores did not reach clinical significance. No significant difference in PROMIS PI was noted at long-term follow-up (.75). CONCLUSIONS: Although a statistically significant difference was observed for improvement in pain, in this retrospective study, TFSNRI did not provide clinically significant improvement in patients' function, pain, or depression for lumbar spinal stenosis at short- and long-term follow-up.

First-Time Lumbar Medial Branch Radiofrequency Ablation: Patient-Reported Outcomes Measurement Information System as a Metric of Outcome.

OBJECTIVE: To investigate the ability of Patient-Reported Outcomes Measurement Information System (PROMIS) to capture the therapeutic effect of first-time medial branch radiofrequency ablation (RFA). DESIGN: Before-after trial. SETTING: Single academic spine center. PARTICIPANTS: Patients who underwent first-time medial branch RFA for lumbar facet joint pain identified by dual comparative medial branch block with ≥80% pain relief between January 1, 2015 and September 1, 2019 were identified using procedural billing codes. Charts were reviewed manually to confirm accuracy and strict adherence to the 80% pain relief threshold for each medial branch block. Thirty-nine patients met the criteria and were included in this study (N=39). INTERVENTIONS: Medial branch RFA. MAIN OUTCOME MEASURES: PROMIS score domains of Depression, Pain Interference, and Physical Function collected pre- and post RFA were compared. Pretreatment scores were within 6 weeks prior to the first medial branch block. Posttreatment scores were between 5 weeks and 6 months after RFA. Paired-sample t test analyses were used to calculate responsiveness to treatment, with significance assigned as P<.05 prior to acquiring data. Effect size was calculated using Cohen's d. RESULTS: PROMIS domains of Pain Interference and Physical Function demonstrated a statistically significant improvement (P=.004 and P=.017, respectively). The PROMIS domain of Depression did not demonstrate a statistically significant change (P=.12). The effect size was medium (d=-0.43) for Pain Interference, small/medium (d=0.31) for Physical Function, and small (d=-0.12) for Depression. CONCLUSIONS: Medial branch RFA as a treatment for lumbar facet syndrome is associated with a statistical improvement in PROMIS domains of Physical Function and Pain Interference.

The vaginal distention model in mice is not a reliable model of simulated birth trauma-induced stress urinary incontinence.

AIMS: Vaginal distention (VD) is a validated model of birth-related trauma in rats. Recently a mouse VD model was reported. Our study was originally conducted to evaluate the impact of age on VD in mice. This manuscript describes the study and reports on the lack of reproducibility of VD models in mice. METHODS: We utilized female C57BL/6 mice. A total of 190, 12-weeks old mice, were randomized into VD and sham groups. We inflated a modified Foley's balloon with 0.3 mL for 1 h inside the mice vagina. Afterwards, we measured the leak point pressure (LPP) at defined timepoints (0, 4, 10, 20, or 40 days). We randomized another 190, 40-week old, C57BL/6 mice into either VD or sham groups. We used an extra 20 mice as age - matched controls. RESULTS: In both 12 and 40 weeks-old mice, LPP was significantly decreased versus the negative controls at day 0. Additionally, in both 12 and 40 weeks-old mice, the decrease in LPP was significantly higher in the VD group compared to the sham group at day 0. However, the LPP results were comparable between VD and sham at any other time point thereafter. Furthermore, there was no significant change in LPP values between instrumented (VD and sham) mice and control mice at any time after day 0. CONCLUSIONS: The VD models previously described is not a reproducible model for the study of VD with large number of mice. Our results, unfortunately, do not support its use to study VD injury in mice.