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

NCT02773134 | Completed

• 1 other identifier: 2009-03-22
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Degenerative Conditions

Keywords

Post-operative Bracing; Rigid Lumbosacral Orthosis; Posterior Spine Fusion; Quality of Life; Lumbar Degenerative Conditions

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks postoperatively, 3 months postoperatively

Secondary Outcomes (3)

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

  Baseline, 6 weeks postoperatively, 3 months postoperatively.

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

  Baseline, 6 weeks postoperatively, 3 months postoperatively.

• Change in Visual Analog Scale (VAS) for back pain

  Baseline, 6 weeks postoperatively, 3 months postoperatively.

Study Arms (2)

Brace Group

ACTIVE COMPARATOR

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.

Other: Brace Group

Control Group

EXPERIMENTAL

No brace prescription postoperatively. Patients in this group will be observed and results will be compared to the brace group.

Other: Control Group

Interventions

Brace Group OTHER

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.

Brace Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 16, 2016
• Study Start: March 1, 2009
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 26, 2025

Record last verified: 2016-05