The Effects of Spinal Manipulation on Performance on Neck Pain Patients During a Fitts' Task

Sponsor
University of Manitoba (Other)
Overall Status
Completed
CT.gov ID
NCT04347551
Collaborator
(none)
40
1
2
2.8
14.3

Study Details

Study Description

Brief Summary

The objective of this study is to quantify motor performance, this study will use an eye movement Fitts' task to examine the effects of cervical spine manipulation on participants with chronic neck pain and the subsequent changes to saccade movement time. This study will also include a head movement Fitts' task which has previously reported a reduction in head movement time in chronic neck pain participants after cervical spine manipulation.

This is an observational within-subjects design that involves a pre/post cervical spine manipulation intervention on participants (n=20) with chronic neck pain and asymptomatic controls (n=20). All participants will complete an eye movement and head movement Fitts' task before and after cervical spine manipulation to identify any changes in saccade and head movement time, saccade and head peak velocity, and time to peak saccade and head velocity.

Condition or Disease Intervention/Treatment Phase
  • Other: High velocity/low amplitude cervical spine manipulation
N/A

Detailed Description

The purpose of this study is to measure the effects of cervical spine manipulation on the motor performance of participants with and without chronic neck pain.

The objective of this pre/post design study is to apply spinal manipulation of the cervical spine to participants with chronic neck pain and participants who are asymptomatic for neck pain, and to measure the subsequent changes of movement time of the eyes during an eye movement Fitts' task using eye-tracker technology.

This study will also include a head movement Fitts' task, which has been previously shown to identify a reduction in head movement time in participants after receiving cervical spine manipulation. The head movement task, which has a biomechanical basis, will serve as a comparator to the eye movement task, which has a neurophysiologic basis. Changes in head and eye movement time are both measures of motor performance.

The hypothesis for the eye movement Fitts' task, is that the eye movement time will be increase with larger distances between targets and will not be affected by changes in target width. It is anticipated that the eye movement time will reduce in the neck pain group following spinal manipulation in comparison to the asymptomatic group. We hypothesize that during the head movement task, symptomatic participants will experience a decrease in head movement time as compared to the asymptomatic group after spinal manipulation. We further hypothesize that head movement time will be increase with larger target distances and smaller target widths.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is an observational within-subjects design that involves a pre/post cervical spine manipulation intervention on participants (n=20) with chronic neck pain and asymptomatic controls (n=20). All participants will complete an eye movement and head movement Fitts' task before and after cervical spine manipulation to identify any changes in eye and head movement time, eye and head peak velocity, and time to peak eye and head velocity.This is an observational within-subjects design that involves a pre/post cervical spine manipulation intervention on participants (n=20) with chronic neck pain and asymptomatic controls (n=20). All participants will complete an eye movement and head movement Fitts' task before and after cervical spine manipulation to identify any changes in eye and head movement time, eye and head peak velocity, and time to peak eye and head velocity.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Motor Performance of Asymptomatic and Chronic Neck Pain Participants Pre- and Post-spinal Manipulation Using an Eye and Head Movement Fitts' Task
Actual Study Start Date :
May 25, 2021
Actual Primary Completion Date :
Aug 18, 2021
Actual Study Completion Date :
Aug 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eye movement Fitts' task

High velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants.

Other: High velocity/low amplitude cervical spine manipulation
The participants will receive a single cervical spine rotary manipulation to the previously identified palpable cervical segmental fixation. During the performance of the manipulation, the supine participant will rest their arms at the sides of their body. Next, the index finger of the chiropractor's contact hand will be placed on the lamina of the restricted cervical segment. The chiropractor will then rotate the participant's head contralaterally until the barrier of the cervical segments volitional end range is reached. The chiropractor's other hand will be placed behind the participant's head to induce gentle neck rotation contralateral to the chiropractor's thrusting hand. The chiropractor will deliver a manual thrust, with the thrust vector directed towards the participant's opposite eye.
Other Names:
  • Cervical manipulation
  • Neck manipulation
  • Cervical adjustment
  • Neck adjustment
  • Active Comparator: Head movement Fitts' task

    High velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants.

    Other: High velocity/low amplitude cervical spine manipulation
    The participants will receive a single cervical spine rotary manipulation to the previously identified palpable cervical segmental fixation. During the performance of the manipulation, the supine participant will rest their arms at the sides of their body. Next, the index finger of the chiropractor's contact hand will be placed on the lamina of the restricted cervical segment. The chiropractor will then rotate the participant's head contralaterally until the barrier of the cervical segments volitional end range is reached. The chiropractor's other hand will be placed behind the participant's head to induce gentle neck rotation contralateral to the chiropractor's thrusting hand. The chiropractor will deliver a manual thrust, with the thrust vector directed towards the participant's opposite eye.
    Other Names:
  • Cervical manipulation
  • Neck manipulation
  • Cervical adjustment
  • Neck adjustment
  • Outcome Measures

    Primary Outcome Measures

    1. Change in eye (saccade) movement time [Change from baseline saccade movement time immediately following cervical spine manipulation.]

      Eye (saccade) movement time (milliseconds), which is the time between saccade onset and offset while moving from central circle to the target.

    2. Change in head movement time [Change from baseline head movement time immediately following cervical spine manipulation.]

      Head movement time (milliseconds) is the time required to move the cursor from the central circle to the target.

    Secondary Outcome Measures

    1. Change in saccade peak velocity [Change from baseline saccade peak velocity immediately following cervical spine manipulation.]

      Peak of the velocity amplitude (meters/second) in the horizontal movement direction

    2. Change in time to peak saccade velocity [Change from baseline time to peak velocity immediately following cervical spine manipulation.]

      Measured as the time (milliseconds) from the onset of velocity to its peak amplitude

    3. Change in head peak velocity [Change from baseline head peak velocity immediately following cervical spine manipulation.]

      Measured as the peak of the velocity amplitude (meters/second) of the cursor moving in the horizontal plane

    4. Change in time to peak head velocity [Change from baseline time to peak head velocity immediately following cervical spine manipulation.]

      The time (milliseconds) to peak velocity will be measured as the time from the onset of velocity to its peak amplitude.

    Other Outcome Measures

    1. Change in Visual analog scale (VAS) score [Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.]

      100 mm visual analog scale (VAS) to score their pain intensity

    2. The Neck Disability Index (NDI) score [Baseline prior to cervical spine manipulation]

      To quantify neck disability related to work and physical activity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Participants with neck pain:

    Inclusion criteria

    • Between the ages of 18 and 40

    • Neck pain for at least 3 months

    • Palpable spinal segmental fixations at C1-7

    • Neck pain must be reproducible by neck movements and/or provocative

    • Normal or corrected-to-normal vision

    Exclusion criteria

    • Contraindications to spinal manipulation

    • Can't be calibrated during the eye movement Fitts task (excluded from eye movement test only)

    • Progressive neurologic deficits

    • Cervical spine trauma or surgery

    • Infection, tumor, osteoporosis, inflammatory spondyloarthropathy, spinal fracture, and a history of vestibular/inner ear dysfunction

    • Diagnosed with an autonomic disorder such as Horner's syndrome

    • Any current ocular and/or retinal disease, Diabetes, a history of head trauma

    • Currently using opioids, recreational drugs or have a history of substance abuse

    Asymptomatic participants:

    Inclusion criteria

    • Between the ages of 18 and 40

    • No neck pain for at least 3 months

    • Palpable spinal segmental fixations at C1-7

    • Normal or corrected-to-normal vision

    Exclusion criteria

    • Contraindications to spinal manipulation

    • Can't be calibrated during the eye movement Fitts task (excluded from eye movement test only)

    • Progressive neurologic deficits

    • Cervical spine trauma or surgery

    • Infection, tumor, osteoporosis, inflammatory spondyloarthropathy, spinal fracture, and a history of vestibular/inner ear dysfunction

    • Diagnosed with an autonomic disorder such as Horner's syndrome

    • Any current ocular and/or retinal disease, Diabetes, a history of head trauma

    • Currently using opioids, recreational drugs or have a history of substance abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gelley Chiropractic Office Winnipeg Manitoba Canada R2M 5M3

    Sponsors and Collaborators

    • University of Manitoba

    Investigators

    • Principal Investigator: Geoff Gelley, DC, MSc, University of Manitoba

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Geoff Gelley, PhD Candidate, University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT04347551
    Other Study ID Numbers:
    • B2020:010
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Geoff Gelley, PhD Candidate, University of Manitoba
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2021