NCT02118103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

April 16, 2014

Last Update Submit

April 16, 2015

Conditions

Spinal Stenosis

Keywords

Lumbosacral RegionPsychomotor PerformanceManipulation, Spinal

Outcome Measures

Primary Outcomes (7)

  • Active Lumbar Range of Motion (ROM)

    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).

    same 1 day, prior to and following intervention or non-intervention

  • Reaction Time

    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.

    same 1 day, during foot pointing tasks

  • Movement Time

    Movement time (milliseconds) will be defined as the time between toe lift off from the home position and contact with the target.

    same 1 day, during foot pointing tasks

  • Spatial Endpoint Accuracy

    Spatial endpoint accuracy will be the distance from the center of the toe pad touch down to the center of the target.

    same 1 day, during foot pointing tasks

  • Displacement

    measured in millimeters

    same 1 day, during foot pointing tasks

  • Peak Velocity

    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.

    same 1 day, during foot pointing tasks

  • Time to Peak Velocity

    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.

    same 1 day, during foot pointing tasks

Study Arms (2)

Spinal Manipulation

EXPERIMENTAL

bilateral lumbar spine manipulation

Procedure: Spinal Manipulation

No Intervention - control

NO INTERVENTION

no intervention

Interventions

Spinal ManipulationPROCEDURE

Lumbar spinal manipulation

Spinal Manipulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Lumbar Spinal Stenosis Diagnosis (by diagnostic imaging and clinical testing/history from a spine surgeon)

You may not qualify if:

  • Prior surgery to address Spinal Stenosis
  • Presence of trauma, tumor, or infectious processes that are contraindications to spinal manipulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre (Rehab Hospital, RR-309)

Winnipeg, Manitoba, Canada

Location

Related Publications (14)

  • Beamish D, Bhatti SA, MacKenzie IS, Wu J. Fifty years later: A neurodynamic explanation of Fitts' law. J R Soc Interface. 2006 Oct 22;3(10):649-54. doi: 10.1098/rsif.2006.0123.

    PMID: 16971333BACKGROUND

  • Peterson, D.H., Bergmann, T.F., editors. Chiropractic technique. 2nd ed. St. Louis: Mosby; 2002 p.308-309.

    BACKGROUND

  • 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. doi: 10.1111/j.1532-5415.1996.tb00915.x.

    PMID: 8600197BACKGROUND

  • Descarreaux M, Passmore SR, Cantin V. Head movement kinematics during rapid aiming task performance in healthy and neck-pain participants: the importance of optimal task difficulty. Man Ther. 2010 Oct;15(5):445-50. doi: 10.1016/j.math.2010.02.009. Epub 2010 Jun 25.

    PMID: 20579929BACKGROUND

  • Elias LJ, Bryden MP, Bulman-Fleming MB. Footedness is a better predictor than is handedness of emotional lateralization. Neuropsychologia. 1998 Jan;36(1):37-43. doi: 10.1016/s0028-3932(97)00107-3.

    PMID: 9533385BACKGROUND

  • FITTS PM. The information capacity of the human motor system in controlling the amplitude of movement. J Exp Psychol. 1954 Jun;47(6):381-91. No abstract available.

    PMID: 13174710BACKGROUND

  • FITTS PM, PETERSON JR. INFORMATION CAPACITY OF DISCRETE MOTOR RESPONSES. J Exp Psychol. 1964 Feb;67:103-12. doi: 10.1037/h0045689. No abstract available.

    PMID: 14114905BACKGROUND

  • Guadagnoli MA, Lee TD. Challenge point: a framework for conceptualizing the effects of various practice conditions in motor learning. J Mot Behav. 2004 Jun;36(2):212-24. doi: 10.3200/JMBR.36.2.212-224.

    PMID: 15130871BACKGROUND

  • Jenis 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.

    PMID: 10703115BACKGROUND

  • Katz 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.

    PMID: 18287604BACKGROUND

  • Onla-or S, Winstein CJ. Determining the optimal challenge point for motor skill learning in adults with moderately severe Parkinson's disease. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):385-95. doi: 10.1177/1545968307313508. Epub 2008 Mar 8.

    PMID: 18326891BACKGROUND

  • Passmore SR, Burke J, Lyons J. Older adults demonstrate reduced performance in a Fitts' task involving cervical spine movement. Adapt Phys Activ Q. 2007 Oct;24(4):352-63. doi: 10.1123/apaq.24.4.352.

    PMID: 18042971BACKGROUND

  • 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. doi: 10.1097/00007632-200201010-00020.

    PMID: 11805642BACKGROUND

  • 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. doi: 10.1097/00007632-199604010-00004.

    PMID: 8779009BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Steven Passmore, DC, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Steven Passmore, DC, PhD

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

CA(1)