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Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery

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ClinicalTrials.gov Identifier: NCT02154191
Recruitment Status : Unknown
Verified June 2015 by Dr. Steven Passmore, University of Manitoba.
Recruitment status was:  Enrolling by invitation
First Posted : June 3, 2014
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Gibson Orthopaedic Fund for Research and Education
Information provided by (Responsible Party):
Dr. Steven Passmore, University of Manitoba

Brief Summary:
The purpose of the proposed research is to explore the relationship between objectively measured physical activity and surgical intervention for lumbar spinal stenosis (LSS). Our primary hypothesis is that post-surgery, LSS patients will demonstrate increased physical activity compared to their baseline assessment. A non-intervention control group will be measured at the same time intervals as the surgical group to look at test re-test reliability. In the event that our hypothesis is rejected, and surgery does not lead to a decrease in sedentary behaviour analysis of questionnaire-based sedentary behaviour measures and objective activity-based measurement can examine the relationship between self-report and actual performance-based objective measures. The primary objective of our proposal is to determine if surgical intervention leads to increased activity, and decreased sedentary behaviour. The findings of the proposed research will inform healthcare stakeholders that if surgery alone does not lead to increased activity, a more concerted research effort may need to be made for post-surgical rehabilitation, lifestyle and physical activity counselling so that post-surgical patients may make changes toward leading more active and productive lives.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Procedure: Surgical Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Surgical Intervention Group
The Surgical Intervention Group will undergo the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.
Procedure: Surgical Intervention
The clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.

No Intervention: Non-Intervention Group (Control)
No Intervention.This group will consist of patients wait listed for surgery but further back in the queue.



Primary Outcome Measures :
  1. Activity Measure - Volume [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using volume (e.g., activity counts/day).

  2. Activity Measure - Rate [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using rate (e.g., average steps/minute/day).

  3. Activity Measure - Time Indicators [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using time indicators (e.g., time spent in sedentary, light, moderate and high intensity physical activity categories/day) using standard cut-point thresholds.

  4. Activity Measure - Maximum Continuous Daily Activity [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    The maximum number of consecutive minutes at or above 100 activity counts/min (a threshold thought to represent low intensity activity) with no more than 1 min of activity below this low intensity threshold will be determined along with the average duration of activity bouts/day.

  5. Activity Measure - Sedentary Bout Length [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    Collected by ActiGraph wGT3X+ activity monitor

  6. Activity Measure - Maximum Bout Length [ Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention) ]
    Collected by ActiGraph wGT3X+ activity monitor

  7. Self-Report Measures - Swiss Spinal Stenosis Scale [ Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups. ]
    Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  8. Self-Report Measures - Quadruple Numeric Rating Scale (QNRS) [ Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups. ]
    Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  9. Self-Report Measures - Fear Avoidance Belief Questionnaire (FABQ) [ Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups. ]
    Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  10. Self-Report Measures - Sedentary Behaviors Questionnaire (SBQ) [ Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups. ]
    Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  11. Self-Report Measures - Short Form Health Survey (SF-36) [ Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups. ]
    Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed clinical diagnosis of lumbar spinal stenosis through diagnostic imaging and clinical testing/history from a spine surgeon
  • Considered pre-surgical but in need of surgery (surgical necessity also confirmed by a spine surgeon)

Exclusion Criteria:

  • Not in immediate surgical need
  • No diagnosis of degenerative lumbar spinal stenosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154191


Locations
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Canada, Manitoba
Health Sciences Centre (Rehab Hospital, RR-309)
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Gibson Orthopaedic Fund for Research and Education
Investigators
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Principal Investigator: Steven Passmore, DC, PhD University of Manitoba
Publications:
World Health Organization. Towards a Common Language for Functioning, Disability and Health. 2002

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Responsible Party: Dr. Steven Passmore, Steven Passmore, DC, PhD, University of Manitoba
ClinicalTrials.gov Identifier: NCT02154191    
Other Study ID Numbers: H2014:176
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by Dr. Steven Passmore, University of Manitoba:
Lumbosacral Region
Sedentary Lifestyle
Surgical Procedure, Operative
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases