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
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hopital du Sacre-Coeur de Montreal |
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 |