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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02154191
• Date of registration: 23/05/2014
• Prospective Registration: Yes
• Primary sponsor: University of Manitoba
• Public title: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery
• Scientific title: Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
• Date of first enrolment: June 2014
• Target sample size: 24
• Recruitment status: Enrolling by invitation
• URL: http://clinicaltrials.gov/show/NCT02154191
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Steven Passmore, DC, PhD
• Affiliation: University of Manitoba

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Spinal Stenosis

Intervention(s)

Procedure: Surgical Intervention

Primary Outcome(s)

Activity Measure - Rate [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Activity Measure - Maximum Bout Length [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Self-Report Measures - Quadruple Numeric Rating Scale (QNRS) [Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups.]

Activity Measure - Time Indicators [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Activity Measure - Maximum Continuous Daily Activity [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Self-Report Measures - Fear Avoidance Belief Questionnaire (FABQ) [Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups.]

Self-Report Measures - Sedentary Behaviors Questionnaire (SBQ) [Time Frame: Change between responses collected at baseline, and 6 weeks later for both 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.]

Activity Measure - Sedentary Bout Length [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Activity Measure - Volume [Time Frame: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)]

Self-Report Measures - Swiss Spinal Stenosis Scale [Time Frame: Change between responses collected at baseline, and 6 weeks later for both groups.]

Secondary ID(s)

H2014:176

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gibson Orthopaedic Fund for Research and Education