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

Lumbar Degenerative Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773134
• Other study ID #: 2009-03-22
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: May 11, 2016
• Start date: March 2009
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

• Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease) scheduled for an elective PSIF who agreed to participate in the study were included.

Exclusion Criteria:

• Patients with obesity (BMI > 35kg/m2) were excluded because of the difficulty to properly fit a rigid brace in these patients.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Lumbar Degenerative Conditions

Intervention

Other:
• 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 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. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Baseline, 6 weeks postoperatively, 3 months postoperatively.	No
Secondary	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.	Baseline, 6 weeks postoperatively, 3 months postoperatively.	No
Secondary	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.	Baseline, 6 weeks postoperatively, 3 months postoperatively.	No