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

NCT02154191 | Unknown

• 1 other identifier: H2014:176
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis

Keywords

Lumbosacral Region; Sedentary Lifestyle; Surgical Procedure, Operative

Outcome Measures

Primary Outcomes (11)

• Activity Measure - Volume

  Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using volume (e.g., activity counts/day).

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Activity Measure - Rate

  Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using rate (e.g., average steps/minute/day).

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Activity Measure - Time Indicators

  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.

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Activity Measure - Maximum Continuous Daily Activity

  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.

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Activity Measure - Sedentary Bout Length

  Collected by ActiGraph wGT3X+ activity monitor

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Activity Measure - Maximum Bout Length

  Collected by ActiGraph wGT3X+ activity monitor

  Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)

• Self-Report Measures - Swiss Spinal Stenosis Scale

  Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  Change between responses collected at baseline, and 6 weeks later for both groups.

• Self-Report Measures - Quadruple Numeric Rating Scale (QNRS)

  Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  Change between responses collected at baseline, and 6 weeks later for both groups.

• Self-Report Measures - Fear Avoidance Belief Questionnaire (FABQ)

  Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  Change between responses collected at baseline, and 6 weeks later for both groups.

• Self-Report Measures - Sedentary Behaviors Questionnaire (SBQ)

  Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  Change between responses collected at baseline, and 6 weeks later for both groups.

• Self-Report Measures - Short Form Health Survey (SF-36)

  Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.

  Change between responses collected at baseline, and 6 weeks later for both groups.

Study Arms (2)

Surgical Intervention Group

EXPERIMENTAL

The Surgical Intervention Group will undergo the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.

Procedure: Surgical Intervention

Non-Intervention Group (Control)

NO INTERVENTION

No Intervention.This group will consist of patients wait listed for surgery but further back in the queue.

Interventions

Surgical Intervention PROCEDURE

The clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.

Surgical Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Gibson Orthopaedic Fund for Research and Education: collaborator

Study Sites (1)

Health Sciences Centre (Rehab Hospital, RR-309)

Winnipeg, Manitoba, Canada

Location

Related Publications (24)

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  BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Sedentary Behavior

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Study Officials

• Steven Passmore, DC, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven Passmore, DC, PhD

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

CA (1)