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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

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE March 2009
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions
Official Title  ICMJE The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Degenerative Conditions
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Brace Group
  • Experimental: Control Group
    No brace prescription postoperatively. Patients in this group will be observed and results will be compared to the brace group.
    Intervention: Other: Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773134
Other Study ID Numbers  ICMJE 2009-03-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jean-Marc Mac-Thiong, Hopital du Sacre-Coeur de Montreal
Study Sponsor  ICMJE Hopital du Sacre-Coeur de Montreal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hopital du Sacre-Coeur de Montreal
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP