Clinical trial NCT02154191: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery
Official title: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis
Keywords: Lumbosacral Region
Sedentary Lifestyle
Surgical Procedure, Operative
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Gibson Orthopaedic Fund for Research and Education
First posted: 2014-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Apparatus:

Activity Monitors: The ActiGraph GT3X+ monitor (ActiGraph, Pensacola, FL) has been shown to be reliable and to have good validity under both laboratory and free living conditions. It is one of the most widely respected monitors used for measuring physical activity and sedentary behaviour and is currently being used in an intervention trial with patients with LSS . The GT3X+ monitor includes a triaxial accelerometer, an inclinometer and light sensor. It is capable of measuring activity counts, steps, position relative to gravity and can discriminate between day and night. This accelerometer based sensor system does not impede normal movement and can be worn throughout the day on the waistband, in virtually all environments, except in water. The wGT3X+ activity monitor has the capacity to collect data at up to 100Hz.

Procedure:

Each participant will be given an ActiGraph wGT3X+ activity monitor with instructions to wear the monitor during waking hours over 7 consecutive days except when bathing, showering or swimming. Each ActiGraph monitor will be fastened to a belt over the anterior axillary line at the right hip as per the manufacturer's recommendations and initialized to collect data in 1s epochs. They will also be asked to complete log sheets recording the time they put the monitor on and take it off each day. Participants will complete 2 separate 7-day bouts, six weeks apart.

For the surgical group the ActiGraph will be used in the week leading up to their surgical intervention. The follow-up will occur 6-weeks post surgery. For the no intervention group the ActiGraph will be used in the week immediately after it is determined they are a surgical candidate, and the follow-up will occur 6-weeks later while they are on the surgical waitlist.

Pre-Surgery test:

They will receive the device at a pre-surgical assessment when they will complete their baseline questionnaires, and they will return the device upon their presentation for scheduled surgery.

Post-Surgery test:

When the patient presents for their 6-week post surgical follow-up they will again receive the device, complete questionnaire forms, and be given the device with a postage-paid Express Post envelope to return the monitor to the researchers once they are done with it. Upon arrival of the device, the participant compensation will be issued.

Pre-No Intervention test:

Immediately following the assessment visit when it is determined that the patient is a surgical candidate they will receive the device and complete their baseline questionnaires. In addition, patients will be given a postage-paid Express Post envelope to return the monitor to the researchers once they are done with the it.

Post-No Intervention test:

Six weeks later, the patient will be asked to report to the laboratory where they will again receive the device, complete questionnaire forms, and be given the device with a postage-paid Express Post envelope to return the monitor to the researchers once they are done with it. Upon arrival of the device, the participant compensation will be issued.

Statistical Analysis:

To identify possible explanatory variables, multiple regression will be used to determine relationships between physical activity and sedentary behaviour data (e.g., number of minutes of sedentary, light, moderate physical activity/day, maximum number of consecutive minutes at or above 100 activity counts/ min, maximum sedentary bout length) with demographic factors such as age, duration of diagnosis, body mass index, pain ratings.

Separate paired student's t-tests will be used to compare participants to themselves in terms baseline and follow-up questionnaire scores. Separate unpaired student's t-tests will compare questionnaire based outcome measure scores between groups pre and post intervention. Repeated measures analysis of variance will be used to compare pre- and post-intervention measurements of physical activity and sedentary behaviour within and between groups. Specifically, for all ActiGraph recorded measures separate 2 Group (Surgery, NI) x 2 Time (pre, post) analysis of variance (ANOVA) designs will be employed. Post-hoc analysis will be performed on effects involving more than two means, as needed, using Tukey's Honestly Significant Difference (HSD).

To compare the agreement between the self-report measures and the direct activity monitor data, intra-class correlation (ICC) two-way mixed models will be used.

Adverse Events/Serious Adverse Events:

While this study includes clinical intervention the outcome measures of interest pre- and post-surgery would not be predicted to yield any adverse events. The surgical procedures used are not considered part of the experimental design. The clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis. If the patients were not enrolled in the study they would be under equal risk for adverse events as a result of the clinical intervention.

Planned Dissemination:

The results of this study will be prepared for dissemination first at relevant clinical and scientific conferences. Subsequently, this work will be submitted to a peer-reviewed journal for consideration of publication.

Additional Ethical Aspects of Protocol:

Potential Benefits to Participants and Others:

The potential benefits of participation to participants include receiving $10 parking reimbursement, on two occasions, and an online gift card for $40 from a grocery store. There are no other direct benefits for participating in this study.

Indirect benefits include knowledge that they have contributed to the advancement of scientific understanding the relationship of physical activity pre and post-surgical intervention.

There are no direct benefits to others. Indirect benefits include those to the scientific community through the planned dissemination of the work. The results of this study will be prepared for dissemination first at relevant clinical and scientific conferences. Subsequently, this work will be submitted to a peer reviewed journal for consideration of publication.

Potential harms to Participants and Others:

There is no anticipated potential harm for participants in regard to outcome measure completion. In regard to surgical intervention the risks and potential harms are equal to those of the patient having surgery outside the research study. All patients recruited for this study would otherwise receive the surgery even if not enrolled in the study.

To protect participant privacy all data collected will be coded and put into database format. All data will be de-identified and kept on a single study computer at each site which is password protected and located in a locked office. As such, access to study subject information/data will be highly safeguarded and can only be accessed by Dr. Passmore. Any paper forms and questionnaires will be kept in a locked cabinet in a locked room. Identifying information that will be collected is the subject's name, contact information and date of birth.

Eligibility 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.

Primary outcomes:
measure: Activity Measure - Volume
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Activity Measure - Rate
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Activity Measure - Time Indicators
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Activity Measure - Maximum Continuous Daily Activity
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Activity Measure - Sedentary Bout Length
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Activity Measure - Maximum Bout Length
timeFrame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
measure: Self-Report Measures - Swiss Spinal Stenosis Scale
timeFrame: Change between responses collected at baseline, and 6 weeks later for both groups.
measure: Self-Report Measures - Quadruple Numeric Rating Scale (QNRS)
timeFrame: Change between responses collected at baseline, and 6 weeks later for both groups.
measure: Self-Report Measures - Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Change between responses collected at baseline, and 6 weeks later for both groups.
measure: Self-Report Measures - Sedentary Behaviors Questionnaire (SBQ)
timeFrame: Change between responses collected at baseline, and 6 weeks later for both groups.
measure: Self-Report Measures - Short Form Health Survey (SF-36)
timeFrame: Change between responses collected at baseline, and 6 weeks later for both groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre (Rehab Hospital, RR-309)
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Steven Passmore, DC, PhD
role: PRINCIPAL_INVESTIGATOR
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