The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions

Not Applicable

Completed

• Conditions: Lumbar Degenerative Conditions
• Interventions: Other: Brace Group; Other: Control Group

• Registration Number: NCT02773134
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Brief Summary

Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients with lumbar degenerative conditions with the aim of improving pain relief and quality of life. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons choose to use braces mainly based on their experience and training.

The aim of this study is to investigate whether wearing a brace after PSIF can improve pain relief and quality of life (QOL) 6 weeks and 3 months after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-13
• Study First Posted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease);
• Patients scheduled for an elective posterior spinal fusion.

Exclusion Criteria

• Patients with obesity (BMI > 35kg/m2).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brace Group	Brace Group	Patients in the brace group will be fitted by an orthotist postoperatively and will be instructed to wear a rigid molded Lumbosacral Orthosis (LSO) full time for 8 weeks except during hygiene and wound care followed by daytime wear for another 4 weeks. All patients will start wearing the brace 48 hours after the surgery following removal of the wound drain. All braces will be molded and fitted by the same experienced orthotist affiliated with the hospital. Self-compliance to brace wear will be noted every day for 3 months by each patient on a specific form.
Control Group	Control Group	No brace prescription postoperatively. Patients in this group will be observed and results will be compared to the brace group.

Primary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (ODI) score following the surgery.	Baseline, 6 weeks postoperatively, 3 months postoperatively	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

Secondary Outcome Measures

Name	Time	Method
Change in SF-12v2 Mental Component Score (MCS)	Baseline, 6 weeks postoperatively, 3 months postoperatively.	SF-12v2® Health Survey measures eight health domains and provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.
Change in SF-12v2 Physical Component Score (PCS)	Baseline, 6 weeks postoperatively, 3 months postoperatively.	SF-12v2® and SF-8™ Health Surveys measure the same eight health domains, and each survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.
Change in Visual Analog Scale (VAS) for back pain	Baseline, 6 weeks postoperatively, 3 months postoperatively.	The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.