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

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Lumbar Degenerative Conditions

Interventions

Brace Group

All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours. All patients will complete the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (preoperatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.

Control GroupOTHER

All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours. Bracing will not be prescribed postoperatively for this group. All patients will the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (pre-operatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Change in Oswestry Disability Index (ODI) score following the surgery.

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.

Time frame: Baseline, 6 weeks postoperatively, 3 months postoperatively

Secondary Outcomes

Change in SF-12v2 Physical Component Score (PCS)

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.

Time frame: Baseline, 6 weeks postoperatively, 3 months postoperatively.

Change in SF-12v2 Mental Component Score (MCS)

SF-12v2® Health Survey measures eight health domains and provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.

Time frame: Baseline, 6 weeks postoperatively, 3 months postoperatively.

Change in Visual Analog Scale (VAS) for back pain

The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.

Time frame: Baseline, 6 weeks postoperatively, 3 months postoperatively.