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153. Can cervical transforaminal epidural steroid injections be surgery-sparing?
Proceedings of the 34th Annual Meeting of the North American Spine Society / The Spine Journal 19 (2019) S59−S100 PURPOSE: The purpose of this pilot study was to obtain the preliminary data on the use of autologous bone marrow derived mononuclear cells (BM-MNCs) to treat PIs in terms of clinical outcome and procedure safety. STUDY DESIGN/SETTING: Pilot study. PATIENT SAMPLE: We enrolled individuals with SCIs aged 16 to 60 years with stage 3-4 PIs. Ten Spinal cord injury (SCI) cases were recruited; five cases received autologous bone marrow derived mononuclear cells (BM-MNCs) therapy and five standard wound care. OUTCOME MEASURES: Surface area and depth of PI, exudate volume and formation of granulation tissue. METHODS: About 3 hours before cell therapy, autologous bone marrow (BM) (100 ml) was obtained from the posterior iliac crest aspiration. Mononuclear cells (MNCs) were separated from bone marrow using plasma expresser. The BM-MNCs suspension was injected into the wound bed by 1 ml syringe. For injection, the wound was subdivided with a grid into small areas of 1 cm2. Infusion was performed into the wound bed as well as subdermally at the borders of the wound. Wound dressings during the entire study period were performed with moist gauzes twice a day and followed up to 9 weeks. RESULTS: Physical wound healing outcomes were compared at weeks 3, 6, and 9. Significantly reduced surface area of PI in the BM-MNC treated group was observed at week 6 (p=0.04) and at week 9 (p=0.001) as compared to the standard wound care group. Similarly, significant reduction of depth was observed in the BM-MNC group at week 9 (p<0.05) and exudate became significantly (p=0.001) lower from the 3rd to 9th week. Clearance of slough and formation of red granulation tissue was significantly higher in the BM-MNC group (p=0.001). CONCLUSIONS: The procedure of BM-MNC therapy was safe and well tolerated by the subjects. The efficacy can be better assessed with a larger sample size. But in this study, the results were highly satisfactory. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2019.05.166
153. Can cervical transforaminal epidural steroid injections be surgery-sparing? Kush K. Goyal, MD1, Matthew L. Abbott2; 1 Cleveland Clinic - Lutheran, Cleveland, OH, US; 2 Cleveland, OH, US BACKGROUND CONTEXT: Cervical radiculopathy can have a significant effect on patient quality of life. Cervical transforaminal epidural steroid injections (TF ESIs) have come under scrutiny due to risk of the procedure and lack of literature demonstrating long-term effect. PURPOSE: To determine whether cervical TF ESIs improve patientreported quality-of-life outcomes, offer therapeutic benefit, and whether TF ESIs decrease the need for cervical spine surgery. STUDY DESIGN/SETTING: Hospital-based outpatient medical spine practice. PATIENT SAMPLE: A total of 99 consecutive patients who underwent unilateral cervical TF ESI. Of those, 82 patients were available for analysis who underwent cervical injection between 12/11/2013 and 11/8/2017. Average age was 51.3 (SD = 11.5 years) with 51.2% male, 48.8% female. Levels included 45.1% performed at C5-6, 31.7% at C6-7, and 23% at other cervical levels. Median duration of symptoms was seven months. OUTCOME MEASURES: We evaluated data using validated outcomes measures − PHQ9, PDQ, and PROMIS-Physical. METHODS: Retrospective review of single practitioner’s outcomes after all patients undergoing cervical TF ESIs from 2014-2017. RESULTS: Of the 99 patients, 25 went on to have cervical surgery; 90.2% patients had diagnostic benefit considered to at least 80% immediate relief 4 hours after injection. Only one patient had a complication: a less than 1 minute seizure with lidocaine test dose. History of spine surgery was the only statistically significant predictor to long-term benefit after cervical TF ESI. Patients who had prior spine surgery had a hazard of postinjection surgery that was 4.2 times larger, compared to patients who did not have prior
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spine surgery (P = 0.001). None of the other predictors were significantly associated with time from injection to surgery. Patients who had duration of symptoms of 1 year or more had higher postinjection PDQ scores than patients who had duration of symptoms 3 months or less, and patients who had history of spine surgery had higher postinjection PDQ scores. Overall Mean Visual Analog Score (VAS) decreased mean 7.6 to 4.09 at 3 months (n=82), (P < 0.001). Average percent relief was 67.3% at initial follow-up (n=82, mean follow-up 28 days) and 81.4% at second follow-up (n=25, mean follow-up at 103 days). Mean PDQ: change of 10.75 (standard error 4.52), p=0.021 at 6 months (n=61 at 3 months) (n=38 at 6 months) with mean follow-up 191 days. Mean PHQ-9 change of 1.92 (standard error 0.87), p=0.032 at 6 months, 9 (n=56 at 3 months) (n=25 at 6 months) with mean follow-up 243 days. Mean PROMIS-Physical change of +3.00 (standard error 1.27), p=0.023 at 3 months (n=43), mean follow-up 144 days. CONCLUSIONS: Cervical TF ESIs can be done safely with minimal morbidity and significant benefit at 6 months. In more than 2/3 of the patients, surgery was not needed due to diagnostic and therapeutic benefit from cervical TF ESI. FDA DEVSICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2019.05.167
154. Back pain of degenerative scoliotic patients treated with triple modalities guided radiofrequency ablation-case series with preliminary results Ting-Chun Huang, MD; National Taiwan University Hospital Chu-Tung Branch, Hsinchu County, Taiwan BACKGROUND CONTEXT: Balanced degenerative scoliotic patients with back pain with or without focal neurological signs were sometimes treated with large scale deformity correction surgery. However, postoperative morbidity and even mortalities were noted. Facet syndrome and sacroiliac syndrome could be found and treated on these patients and lower their back pain to a certain degree. PURPOSE: This study is aimed to study the effect of back pain of degenerative scoliotic patients treated with radiofrequency ablation. STUDY DESIGN/SETTING: Prospective non-randomized case series from a single hospital by a single surgeon (author) from May 2017 to January 2019. PATIENT SAMPLE: Patients diagnosed with degenerative scoliosis on plain film with symptoms of low back pain for more than 2 months were enrolled and patients who had focal neurological signs or could not finish the complete follow-up were excluded. OUTCOME MEASURES: Patients were followed up to 6 months (immediate postop, postop 1 mo, 3 mos, 6 mos), and VAS, SF-36, and ODI scores were recorded. METHODS: Radiofrequency ablation was done with fluoroscopic, ultrasound and sensory-motor stimulation guidance under local anesthesia in the operating room. RESULTS: Eleven consecutive cases of (male: female 4:7, average age: 75.7§9.8, Cobb angle: 20.0§11.9, s/p fusion surgery: 4) were enrolled. Average interval: 4.0§2.2 months. (preop, 1 wk, 1 mo, 3 mos, 6 mos, *:P<0.05): VAS (back): (8.7 § 0.5, 6.3§3.6, 4.2§1.3, 5.1§2.5, 3.5§1.5), ODI (72.2§26.5, 60.6§14.7, 40.0§21.1*, 31.2§11.1, 22.2§10.2). SF36 (Physical Health/Mental Health): (25.3§8.8/16.4§7.3, 34.1§10.5/22.5§ 11.6, 36.7§8.1*/24.9§14.2, 36.0§12.3/23.6§2.1*, 50.2§11.3/15.3§5.1) revealed major improvements. No severe complications were noted. CONCLUSIONS: Balanced degenerative scoliotic patients with back pain could have relief of partial back pain by treating facet and sacroiliac pain with radiofrequency ablation as an alternative or analgesics treatment before they underwent large scale deformity correction surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2019.05.168
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.
153. Can cervical transforaminal epidural steroid injections be surgery-sparing? Kush K. Goyal, MD1, Matthew L. Abbott2; 1 Cleveland Clinic - Lutheran, Cleveland, OH, US; 2 Cleveland, OH, US BACKGROUND CONTEXT: Cervical radiculopathy can have a significant effect on patient quality of life. Cervical transforaminal epidural steroid injections (TF ESIs) have come under scrutiny due to risk of the procedure and lack of literature demonstrating long-term effect. PURPOSE: To determine whether cervical TF ESIs improve patientreported quality-of-life outcomes, offer therapeutic benefit, and whether TF ESIs decrease the need for cervical spine surgery. STUDY DESIGN/SETTING: Hospital-based outpatient medical spine practice. PATIENT SAMPLE: A total of 99 consecutive patients who underwent unilateral cervical TF ESI. Of those, 82 patients were available for analysis who underwent cervical injection between 12/11/2013 and 11/8/2017. Average age was 51.3 (SD = 11.5 years) with 51.2% male, 48.8% female. Levels included 45.1% performed at C5-6, 31.7% at C6-7, and 23% at other cervical levels. Median duration of symptoms was seven months. OUTCOME MEASURES: We evaluated data using validated outcomes measures − PHQ9, PDQ, and PROMIS-Physical. METHODS: Retrospective review of single practitioner’s outcomes after all patients undergoing cervical TF ESIs from 2014-2017. RESULTS: Of the 99 patients, 25 went on to have cervical surgery; 90.2% patients had diagnostic benefit considered to at least 80% immediate relief 4 hours after injection. Only one patient had a complication: a less than 1 minute seizure with lidocaine test dose. History of spine surgery was the only statistically significant predictor to long-term benefit after cervical TF ESI. Patients who had prior spine surgery had a hazard of postinjection surgery that was 4.2 times larger, compared to patients who did not have prior
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spine surgery (P = 0.001). None of the other predictors were significantly associated with time from injection to surgery. Patients who had duration of symptoms of 1 year or more had higher postinjection PDQ scores than patients who had duration of symptoms 3 months or less, and patients who had history of spine surgery had higher postinjection PDQ scores. Overall Mean Visual Analog Score (VAS) decreased mean 7.6 to 4.09 at 3 months (n=82), (P < 0.001). Average percent relief was 67.3% at initial follow-up (n=82, mean follow-up 28 days) and 81.4% at second follow-up (n=25, mean follow-up at 103 days). Mean PDQ: change of 10.75 (standard error 4.52), p=0.021 at 6 months (n=61 at 3 months) (n=38 at 6 months) with mean follow-up 191 days. Mean PHQ-9 change of 1.92 (standard error 0.87), p=0.032 at 6 months, 9 (n=56 at 3 months) (n=25 at 6 months) with mean follow-up 243 days. Mean PROMIS-Physical change of +3.00 (standard error 1.27), p=0.023 at 3 months (n=43), mean follow-up 144 days. CONCLUSIONS: Cervical TF ESIs can be done safely with minimal morbidity and significant benefit at 6 months. In more than 2/3 of the patients, surgery was not needed due to diagnostic and therapeutic benefit from cervical TF ESI. FDA DEVSICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2019.05.167
154. Back pain of degenerative scoliotic patients treated with triple modalities guided radiofrequency ablation-case series with preliminary results Ting-Chun Huang, MD; National Taiwan University Hospital Chu-Tung Branch, Hsinchu County, Taiwan BACKGROUND CONTEXT: Balanced degenerative scoliotic patients with back pain with or without focal neurological signs were sometimes treated with large scale deformity correction surgery. However, postoperative morbidity and even mortalities were noted. Facet syndrome and sacroiliac syndrome could be found and treated on these patients and lower their back pain to a certain degree. PURPOSE: This study is aimed to study the effect of back pain of degenerative scoliotic patients treated with radiofrequency ablation. STUDY DESIGN/SETTING: Prospective non-randomized case series from a single hospital by a single surgeon (author) from May 2017 to January 2019. PATIENT SAMPLE: Patients diagnosed with degenerative scoliosis on plain film with symptoms of low back pain for more than 2 months were enrolled and patients who had focal neurological signs or could not finish the complete follow-up were excluded. OUTCOME MEASURES: Patients were followed up to 6 months (immediate postop, postop 1 mo, 3 mos, 6 mos), and VAS, SF-36, and ODI scores were recorded. METHODS: Radiofrequency ablation was done with fluoroscopic, ultrasound and sensory-motor stimulation guidance under local anesthesia in the operating room. RESULTS: Eleven consecutive cases of (male: female 4:7, average age: 75.7§9.8, Cobb angle: 20.0§11.9, s/p fusion surgery: 4) were enrolled. Average interval: 4.0§2.2 months. (preop, 1 wk, 1 mo, 3 mos, 6 mos, *:P<0.05): VAS (back): (8.7 § 0.5, 6.3§3.6, 4.2§1.3, 5.1§2.5, 3.5§1.5), ODI (72.2§26.5, 60.6§14.7, 40.0§21.1*, 31.2§11.1, 22.2§10.2). SF36 (Physical Health/Mental Health): (25.3§8.8/16.4§7.3, 34.1§10.5/22.5§ 11.6, 36.7§8.1*/24.9§14.2, 36.0§12.3/23.6§2.1*, 50.2§11.3/15.3§5.1) revealed major improvements. No severe complications were noted. CONCLUSIONS: Balanced degenerative scoliotic patients with back pain could have relief of partial back pain by treating facet and sacroiliac pain with radiofrequency ablation as an alternative or analgesics treatment before they underwent large scale deformity correction surgery. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. https://doi.org/10.1016/j.spinee.2019.05.168
Refer to onsite annual meeting presentations and postmeeting proceedings for possible referenced figures and tables. Authors are responsible for accurately reporting disclosure and FDA device/drug status at time of abstract submission.