A randomized controlled trial.
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.
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.
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.
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.
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
∗University of Montreal, Montreal, Canada
†Hôpital du Sacré-Coeur de Montréal, Montreal, Canada
‡CHU Sainte-Justine, Montreal, Canada
§Al Zahraa University Hospital, Al-Azhar University, Cairo, Egypt.
Address correspondence and reprint requests to Jean-Marc Mac-Thiong, MD, PhD, Hôpital du Sacré-Coeur de Montréal, 5400 Gouin Ouest Montréal, Québec H4J 1C5, Canada; E-mail: email@example.com
Received 10 October, 2016
Revised 16 April, 2017
Accepted 19 May, 2017
The manuscript submitted does not contain information about medical device(s)/drug(s).
The orthopaedic department of Hôpital du Sacré-Coeur de Montréal internal funds were received in support of this work.
Relevant financial activities outside the submitted work: board membership, consultancy, patents, royalties, grants, stocks.