Spinal StenosisNCT02154191
Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery
A study testing Surgical Intervention in people with Spinal Stenosis, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Surgical Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not in immediate surgical need
- No diagnosis of degenerative lumbar spinal stenosis.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre (Rehab Hospital, RR-309)
Winnipeg, Manitoba
About this study
Official title: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
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.
Read the 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.
- Conditions
- Spinal Stenosis
- Being tested
- Surgical Intervention
- Keywords
- Lumbosacral Region, Sedentary Lifestyle, Surgical Procedure, Operative
- Medical subject headings
- Spinal Stenosis, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical InterventionProcedure or surgery
The clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention Group | Experimental | The Surgical Intervention Group will undergo the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change between responses collected at baseline, and 6 weeks later for both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Gibson Orthopaedic Fund for Research and Education
- Responsible party
- Principal investigator, Dr. Steven Passmore, University of Manitoba
- Investigators
- Steven Passmore, DC, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154191
- Sponsor's protocol ID
- H2014:176
- Status last verified
- Jun 2015
- First submitted
- 23 May 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aadland E, Andersen JR, Anderssen SA, Kvalheim OM. Physical activity versus sedentary behavior: associations with lipoprotein particle subclass concentrations in healthy adults. PLoS One. 2013 Dec 27;8(12):e85223. doi: 10.1371/journal.pone.0085223. eCollection 2013.
PubMed 24386464Brown HE, Ryde GC, Gilson ND, Burton NW, Brown WJ. Objectively measured sedentary behavior and physical activity in office employees: relationships with presenteeism. J Occup Environ Med. 2013 Aug;55(8):945-53. doi: 10.1097/JOM.0b013e31829178bf.
PubMed 23887700Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. J Am Geriatr Soc. 1996 Mar;44(3):285-90. doi: 10.1111/j.1532-5415.1996.tb00915.x.
PubMed 8600197Conway J, Tomkins CC, Haig AJ. Walking assessment in people with lumbar spinal stenosis: capacity, performance, and self-report measures. Spine J. 2011 Sep;11(9):816-23. doi: 10.1016/j.spinee.2010.10.019. Epub 2010 Dec 8.
PubMed 21145292Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1423-34. doi: 10.1249/mss.0b013e3180616b27.
PubMed 17762377Jenis LG, An HS. Spine update. Lumbar foraminal stenosis. Spine (Phila Pa 1976). 2000 Feb 1;25(3):389-94. doi: 10.1097/00007632-200002010-00022.
PubMed 10703115Katz JN, Harris MB. Clinical practice. Lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):818-25. doi: 10.1056/NEJMcp0708097. No abstract available.
PubMed 18287604Otani K, Takegami M, Fukumori N, Sekiguchi M, Onishi Y, Yamazaki S, Ono R, Otoshi K, Hayashino Y, Fukuhara S, Kikuchi S, Konno S; LOHAS Research Group. Locomotor dysfunction and risk of cardiovascular disease, quality of life, and medical costs: design of the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS) and baseline characteristics of the study population. J Orthop Sci. 2012 May;17(3):261-71. doi: 10.1007/s00776-012-0200-5. Epub 2012 Apr 12.
PubMed 22526710Pratt RK, Fairbank JC, Virr A. The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine (Phila Pa 1976). 2002 Jan 1;27(1):84-91. doi: 10.1097/00007632-200201010-00020.
PubMed 11805642Pryce R, Johnson M, Goytan M, Passmore S, Berrington N, Kriellaars D. Relationship between ambulatory performance and self-rated disability in patients with lumbar spinal stenosis. Spine (Phila Pa 1976). 2012 Jul 1;37(15):1316-23. doi: 10.1097/BRS.0b013e31824a8314.
PubMed 22261635Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8.
PubMed 23397303Santos-Lozano A, Marin PJ, Torres-Luque G, Ruiz JR, Lucia A, Garatachea N. Technical variability of the GT3X accelerometer. Med Eng Phys. 2012 Jul;34(6):787-90. doi: 10.1016/j.medengphy.2012.02.005. Epub 2012 Mar 13.
PubMed 22417978Schulte TL, Schubert T, Winter C, Brandes M, Hackenberg L, Wassmann H, Liem D, Rosenbaum D, Bullmann V. Step activity monitoring in lumbar stenosis patients undergoing decompressive surgery. Eur Spine J. 2010 Nov;19(11):1855-64. doi: 10.1007/s00586-010-1324-y. Epub 2010 Feb 26.
PubMed 20186442Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976). 1996 Apr 1;21(7):796-803. doi: 10.1097/00007632-199604010-00004.
PubMed 8779009Tomkins-Lane CC, Conway J, Hepler C, Haig AJ. Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis. Arch Phys Med Rehabil. 2012 Nov;93(11):2008-14. doi: 10.1016/j.apmr.2012.05.014. Epub 2012 May 31.
PubMed 22659537
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
- ClinicalTrials.gov ID
- NCT02154191
- Acronym / sponsor ID
- H2014:176
- Conditions
- Spinal Stenosis
- Keywords
- Lumbosacral Region, Sedentary Lifestyle, Surgical Procedure, Operative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Gibson Orthopaedic Fund for Research and Education
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention Group | Experimental | Procedure: Surgical InterventionThe Surgical Intervention Group will undergo the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis. |
| Non-Intervention Group (Control) | No intervention | –No Intervention.This group will consist of patients wait listed for surgery but further back in the queue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Not in immediate surgical need
- No diagnosis of degenerative lumbar spinal stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical InterventionThe clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis. | Procedure or surgery | Surgical Intervention Group |
Primary outcome
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).
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).
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.
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.
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
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
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Background: PubMed 24386464Aadland E, Andersen JR, Anderssen SA, Kvalheim OM. Physical activity versus sedentary behavior: associations with lipoprotein particle subclass concentrations in healthy adults. PLoS One. 2013 Dec 27;8(12):e85223. doi: 10.1371/journal.pone.0085223. eCollection 2013.
- Background: PubMed 23887700Brown HE, Ryde GC, Gilson ND, Burton NW, Brown WJ. Objectively measured sedentary behavior and physical activity in office employees: relationships with presenteeism. J Occup Environ Med. 2013 Aug;55(8):945-53. doi: 10.1097/JOM.0b013e31829178bf.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Passmore, DC, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Intervention in people with Spinal Stenosis, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Measure - Volume (time frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02154191, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.