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

Montreal Sacred Heart Hospital

Status: Completed

Conditions: Lumbar Degenerative Conditions

Treatments: Other: Control Group; Other: Brace Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02773134

2009-03-22

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

43 participants in 2 patient groups

Brace Group

Active Comparator group

Description:

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.

Treatment:

Other: Brace Group

Control Group

Experimental group

Description:

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

Treatment:

Other: Control Group