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

Spinal Stenosis Clinical Trial

Official title:

Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02154191
• Other study ID #: H2014:176
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 23, 2014
• Last updated: June 3, 2015
• Start date: June 2014

Study information

• Verified date: June 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences Centre (Rehab Hospital, RR-309)	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Gibson Orthopaedic Fund for Research and Education

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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. — View Citation

Brown 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. — View Citation

Ciol 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. — View Citation

Conway 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. — View Citation

Haskell 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. — View Citation

Jenis LG, An HS. Spine update. Lumbar foraminal stenosis. Spine (Phila Pa 1976). 2000 Feb 1;25(3):389-94. Review. — View Citation

Katz JN, Harris MB. Clinical practice. Lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):818-25. doi: 10.1056/NEJMcp0708097. Review. — View Citation

Otani 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. — View Citation

Pratt 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. — View Citation

Pryce 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. — View Citation

Rabinovich 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. — View Citation

Santos-Lozano A, Marín PJ, Torres-Luque G, Ruiz JR, Lucía 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. — View Citation

Schulte 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. — View Citation

Stucki 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. — View Citation

Tomkins-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. — View Citation

Tomkins-Lane CC, Haig AJ. A review of activity monitors as a new technology for objectifying function in lumbar spinal stenosis. J Back Musculoskelet Rehabil. 2012;25(3):177-85. doi: 10.3233/BMR-2012-0325. Review. — View Citation

Tomkins-Lane CC, Lafave LM, Parnell JA, Krishnamurthy A, Rempel J, Macedo LG, Moriartey S, Stuber KJ, Wilson PM, Hu R, Andreas YM. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol. BMC Musculoskelet Disord. 2013 Nov 14;14:322. doi: 10.1186/1471-2474-14-322. — View Citation

Troiano RP, Berrigan D, Dodd KW, Mâsse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. — View Citation

Tudor-Locke C, Brashear MM, Johnson WD, Katzmarzyk PT. Accelerometer profiles of physical activity and inactivity in normal weight, overweight, and obese U.S. men and women. Int J Behav Nutr Phys Act. 2010 Aug 3;7:60. doi: 10.1186/1479-5868-7-60. — View Citation

Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, Wilson F, Rabinovich R, Vogiatzis I, Hopkinson NS, Troosters T; PROactive consortium. Validity of six activity monitors in chronic obstructive pulmonary disease: a comparison with indirect calorimetry. PLoS One. 2012;7(6):e39198. doi: 10.1371/journal.pone.0039198. Epub 2012 Jun 20. — View Citation

Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. Review. — View Citation

Wetten AA, Batterham M, Tan SY, Tapsell L. Relative validity of 3 accelerometer models for estimating energy expenditure during light activity. J Phys Act Health. 2014 Mar;11(3):638-47. doi: 10.1123/jpah.2011-0167. Epub 2013 Feb 8. — View Citation

Winter CC, Brandes M, Müller C, Schubert T, Ringling M, Hillmann A, Rosenbaum D, Schulte TL. Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord. 2010 Oct 12;11:233. doi: 10.1186/1471-2474-11-233. — View Citation

World Health Organization. Towards a Common Language for Functioning, Disability and Health. 2002

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No