The Impact of Spinal Manipulation on Lower Extremity Motor Control in Lumbar Spinal Stenosis Patients: a Single-blind Randomized Before-after Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Manitoba
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Spatial Endpoint Accuracy
Study Overview
Brief Summary
The objectives of the proposed research are to quantify the impact on motor performance of a single SM intervention on surgical waitlist patients with degenerative Lumbar Spinal Stenosis (LSS) using a recently established lower extremity movement task: 1) using alterable levels of task difficulty that is resistant to learning and 2) using measurement of movement kinematics.
Detailed Description
METHODOLOGY:
A non-surgical spine care clinician, (physical therapist or chiropractor) who is not the principal investigator, will rule out, through physical examination and history, any further contraindications to lumbar spinal manipulation (SM) prior to intervention. The physical examination will consist of orthopedic tests typically used in clinical practice prior to spinal manipulation intervention. No intervention will be delivered by the principal investigator.
Upon arrival participants will provide consent to the research assistants by filling out the Research Participant Information and Consent Form. They will then complete a battery of questionnaire based outcome measures including a 2 quadruple numeric rating scales (QNRS), one for each left, and right leg pain, the Swiss Spinal Stenosis score (SSS)(Stucki, Daltroy, Liang et al 1996) and the Waterloo Footededness Questionnaire - revised (WFQ-R) (Elias, Bryden, Bulman-Fleming 1998) on a computer. The width and length of the distal pad of the great toe will be measured bilaterally.
Apparatus:
A 23" projected image will be positioned lengthwise in front of the participant on a surface, parallel to the floor but facing the ceiling, on a custom built support frame and platform. A microswitch will be mounted in the support frame platform on the edge proximal to the participant and will serve as the home position. Custom software (E-prime, v 2.0 Psychology Software Tools Inc., Sharpsburg, PA) will be used to generate the projected images, to track switch initiated timing, and trigger/synchronize 3-dimensional movement recording. An infrared emitting diode (IRED), (Northern Digital, Waterloo, ON) will be mounted to the distal aspect of the great toe using a custom removable brace.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed Lumbar Spinal Stenosis Diagnosis (by diagnostic imaging and clinical testing/history from a spine surgeon)
Exclusion Criteria
- •Prior surgery to address Spinal Stenosis
- •Presence of trauma, tumor, or infectious processes that are contraindications to spinal manipulation
Arms & Interventions
Spinal Manipulation
bilateral lumbar spine manipulation
Intervention: Spinal Manipulation (Procedure)
No Intervention - control
no intervention
Outcomes
Primary Outcomes
Spatial Endpoint Accuracy
Time Frame: same 1 day, during foot pointing tasks
Spatial endpoint accuracy will be the distance from the center of the toe pad touch down to the center of the target.
Active Lumbar Range of Motion (ROM)
Time Frame: same 1 day, prior to and following intervention or non-intervention
Active lumbar ROM (in degrees) will include flexion, extension, bilateral lateral flexion and bilateral rotation. It will be compared between groups, both prior to and following intervention (or NI).
Movement Time
Time Frame: same 1 day, during foot pointing tasks
Movement time (milliseconds) will be defined as the time between toe lift off from the home position and contact with the target.
Displacement
Time Frame: same 1 day, during foot pointing tasks
measured in millimeters
Time to Peak Velocity
Time Frame: same 1 day, during foot pointing tasks
Time to peak velocity will be defined as the time point in ms at which the great toe reached peak velocity in the plane of movement toward the target.
Reaction Time
Time Frame: same 1 day, during foot pointing tasks
Reaction time (milliseconds) will be defined as the time between the presentation of the target, to the lift off from the home position of the toe reaching toward the target.
Peak Velocity
Time Frame: same 1 day, during foot pointing tasks
Peak velocity will be defined as the point of greatest velocity (meters per second) of the great toe in the plane of movement toward the target.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Steven Passmore
Steven Passmore, DC, PhD
University of Manitoba