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

September 7, 2021 updated by: Geoff Gelley, University of Manitoba

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manitoba
      • Winnipeg, Manitoba, Canada, R2M 5M3
        • Gelley Chiropractic Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eye movement Fitts' task
High velocity/low amplitude cervical spine manipulation applied to chronic neck pain and asymptomatic participants.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in eye (saccade) movement time
Time Frame: 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.
Change from baseline saccade movement time immediately following cervical spine manipulation.
Change in head movement time
Time Frame: 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.
Change from baseline head movement time immediately following cervical spine manipulation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in saccade peak velocity
Time Frame: Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Peak of the velocity amplitude (meters/second) in the horizontal movement direction
Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Change in time to peak saccade velocity
Time Frame: 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
Change from baseline time to peak velocity immediately following cervical spine manipulation.
Change in head peak velocity
Time Frame: 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
Change from baseline head peak velocity immediately following cervical spine manipulation.
Change in time to peak head velocity
Time Frame: 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.
Change from baseline time to peak head velocity immediately following cervical spine manipulation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual analog scale (VAS) score
Time Frame: Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.
100 mm visual analog scale (VAS) to score their pain intensity
Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.
The Neck Disability Index (NDI) score
Time Frame: Baseline prior to cervical spine manipulation
To quantify neck disability related to work and physical activity.
Baseline prior to cervical spine manipulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2021

Primary Completion (Actual)

August 18, 2021

Study Completion (Actual)

August 18, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2020:010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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