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

Primary Purpose

Chronic Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

High velocity/low amplitude cervical spine manipulation

About this trial

This is an interventional basic science trial for Chronic Neck Pain focused on measuring Manipulation, Spinal, Fitts' Task, Motor Performance

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Gelley Chiropractic Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Eye movement Fitts' task

Head movement Fitts' task

Arm Description

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

Outcomes

Primary Outcome Measures

Change in eye (saccade) movement time

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

Change in head movement time

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

Secondary Outcome Measures

Change in saccade peak velocity

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

Change in time to peak saccade velocity

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

Change in head peak velocity

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

Change in time to peak head velocity

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

Full Information

NCT ID

NCT04347551

First Posted

April 8, 2020

Last Updated

September 7, 2021

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT04347551

Brief Title

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

Official Title

Motor Performance of Asymptomatic and Chronic Neck Pain Participants Pre- and Post-spinal Manipulation Using an Eye and Head Movement Fitts' Task

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

August 18, 2021 (Actual)

Study Completion Date

August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Neck Pain

Keywords

Manipulation, Spinal, Fitts' Task, Motor Performance

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eye movement Fitts' task

Arm Type

Experimental

Arm Description

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

Arm Title

Head movement Fitts' task

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

High velocity/low amplitude cervical spine manipulation

Other Intervention Name(s)

Cervical manipulation, Neck manipulation, Cervical adjustment, Neck adjustment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in eye (saccade) movement time

Description

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

Time Frame

Change from baseline saccade movement time immediately following cervical spine manipulation.

Title

Change in head movement time

Description

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

Time Frame

Change from baseline head movement time immediately following cervical spine manipulation.

Secondary Outcome Measure Information:

Title

Change in saccade peak velocity

Description

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

Time Frame

Change from baseline saccade peak velocity immediately following cervical spine manipulation.

Title

Change in time to peak saccade velocity

Description

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

Time Frame

Change from baseline time to peak velocity immediately following cervical spine manipulation.

Title

Change in head peak velocity

Description

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

Time Frame

Change from baseline head peak velocity immediately following cervical spine manipulation.

Title

Change in time to peak head velocity

Description

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

Time Frame

Change from baseline time to peak head velocity immediately following cervical spine manipulation.

Other Pre-specified Outcome Measures:

Title

Change in Visual analog scale (VAS) score

Description

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

Time Frame

Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.

Title

The Neck Disability Index (NDI) score

Description

To quantify neck disability related to work and physical activity.

Time Frame

Baseline prior to cervical spine manipulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geoff Gelley, DC, MSc

Organizational Affiliation

University of Manitoba

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gelley Chiropractic Office

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2M 5M3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

I will be sharing processed and analyzed data. 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. Datasets will be deposited in the University of Manitoba's Dataverse. The data collected during this study may be shared in an anonymized or de-identified form with academic journals for publication purposes or other researchers according to international guidelines. The data may also be stored by the academic journal under an open access policy in which case it may be used by other researchers for further data analysis and research purposes. Before publishing/sharing any data, it will be reviewed with the Research Ethics Board or oversight committee to ensure full compliance with privacy legislation.

IPD Sharing Time Frame

Uncertain as research has been placed on hold due to the COVID-19 pandemic.

IPD Sharing Access Criteria

Datasets will be deposited in the University of Manitoba's Dataverse. Dataverse is an open source web application to share, preserve, cite, explore, and analyze research data.

IPD Sharing URL

https://dataverse.org

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

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