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

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ClinicalTrials.gov Identifier: NCT02773134
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Jean-Marc Mac-Thiong, Hopital du Sacre-Coeur de Montreal

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.


Condition or disease Intervention/treatment Phase
Lumbar Degenerative Conditions Other: Brace Group Other: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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
Study Start Date : March 2009
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: Brace Group
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

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.


Experimental: Control Group
No brace prescription postoperatively. Patients in this group will be observed and results will be compared to the brace group.
Other: 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.





Primary Outcome Measures :
  1. Change in Oswestry Disability Index (ODI) score following the surgery. [ Time Frame: Baseline, 6 weeks postoperatively, 3 months postoperatively ]
    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.


Secondary Outcome Measures :
  1. Change in SF-12v2 Physical Component Score (PCS) [ Time Frame: Baseline, 6 weeks postoperatively, 3 months postoperatively. ]
    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.

  2. Change in SF-12v2 Mental Component Score (MCS) [ Time Frame: Baseline, 6 weeks postoperatively, 3 months postoperatively. ]
    SF-12v2® Health Survey measures eight health domains and provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.

  3. Change in Visual Analog Scale (VAS) for back pain [ Time Frame: Baseline, 6 weeks postoperatively, 3 months postoperatively. ]
    The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
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Responsible Party: Jean-Marc Mac-Thiong, MD, PhD, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT02773134    
Other Study ID Numbers: 2009-03-22
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jean-Marc Mac-Thiong, Hopital du Sacre-Coeur de Montreal:
Post-operative Bracing
Rigid Lumbosacral Orthosis
Posterior Spine Fusion
Quality of Life
Lumbar Degenerative Conditions
Additional relevant MeSH terms:
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Disease
Pathologic Processes