STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate whether bracing after posterior spinal instrumented fusion (PSIF) can improve pain relief and quality of life (QoL) 6 weeks and 3 months postoperatively. SUMMARY OF BACKGROUND DATA: Braces are commonly prescribed after PSIF in patients with lumbar degenerative conditions with the aim of improving pain relief and QoL. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons use braces mainly based on their experience and training. METHODS: A randomized blinded and controlled trial of 43 patients with PSIF for lumbar degenerative conditions were recruited. The caregivers were blinded but not the orthotist in the present study. There were 25 patients in the brace group and 18 patients in the control group with similar baseline characteristics. All patients completed the Oswestry Disability Index (ODI), the short form (SF)-12v2 General Health Survey and Visual Analog Scale (VAS) for back pain preoperatively, at 6 weeks and 3 months follow-up. Wilcoxon-Mann-Whitney test and a level of significance of 0.05 were used for statistical analyses. RESULTS: Both groups had comparable demographic characteristics, and preoperative SF-12v2, ODI, and VAS scores. The ODI, SF-12v2, and VAS for back pain were improved in comparison to preoperative scores. The improvement was significant at 3 months follow-up regarding ODI and VAS for both groups and significant only for the control group regarding SF-12v2 scores. The improvement in ODI, SF-12v2, and VAS was significantly greater for control group at 3 months postoperatively. Moreover, larger proportion of patients in the control group reached minimum clinically important difference as compared to brace group at 6 weeks and 3 months. CONCLUSION:Postoperative bracing did not result in better improvement in QoL or pain relief up to 3 months after PSIF in patients with lumbar degenerative conditions. LEVEL OF EVIDENCE: 1.
RCT Entities:
STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate whether bracing after posterior spinal instrumented fusion (PSIF) can improve pain relief and quality of life (QoL) 6 weeks and 3 months postoperatively. SUMMARY OF BACKGROUND DATA: Braces are commonly prescribed after PSIF in patients with lumbar degenerative conditions with the aim of improving pain relief and QoL. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons use braces mainly based on their experience and training. METHODS: A randomized blinded and controlled trial of 43 patients with PSIF for lumbar degenerative conditions were recruited. The caregivers were blinded but not the orthotist in the present study. There were 25 patients in the brace group and 18 patients in the control group with similar baseline characteristics. All patients completed the Oswestry Disability Index (ODI), the short form (SF)-12v2 General Health Survey and Visual Analog Scale (VAS) for back pain preoperatively, at 6 weeks and 3 months follow-up. Wilcoxon-Mann-Whitney test and a level of significance of 0.05 were used for statistical analyses. RESULTS: Both groups had comparable demographic characteristics, and preoperative SF-12v2, ODI, and VAS scores. The ODI, SF-12v2, and VAS for back pain were improved in comparison to preoperative scores. The improvement was significant at 3 months follow-up regarding ODI and VAS for both groups and significant only for the control group regarding SF-12v2 scores. The improvement in ODI, SF-12v2, and VAS was significantly greater for control group at 3 months postoperatively. Moreover, larger proportion of patients in the control group reached minimum clinically important difference as compared to brace group at 6 weeks and 3 months. CONCLUSION: Postoperative bracing did not result in better improvement in QoL or pain relief up to 3 months after PSIF in patients with lumbar degenerative conditions. LEVEL OF EVIDENCE: 1.
Authors: Ryan Dimentberg; Saurabh Sinha; Gregory Glauser; Ian F Caplan; James M Schuster; Scott D McClintock; Jang W Yoon; Paul J Marcotte; Zarina S Ali; Neil R Malhotra Journal: Int J Spine Surg Date: 2021-09-22
Authors: Saurabh Sinha; Ian Caplan; James Schuster; Matthew Piazza; Gregory Glauser; Nikhil Sharma; William Charles Welch; Benjamin Osiemo; Scott Mcclintock; Ali Kemal Ozturk; Neil Rainer Malhotra Journal: Asian J Neurosurg Date: 2020-05-29
Authors: Neil Pathak; Michelle C Scott; Anoop R Galivanche; Patrick J Burroughs; Harold G Moore; Ari S Hilibrand; Rohil Malpani; Marissa Justen; Arya G Varthi; Jonathan N Grauer Journal: N Am Spine Soc J Date: 2021-02-27