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

NCT ID: NCT04347551

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-25

Study Completion Date

2021-08-18

Brief Summary

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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

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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.

Conditions

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Chronic Neck Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Eye movement Fitts' task

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

Group Type EXPERIMENTAL

High velocity/low amplitude cervical spine manipulation

Intervention Type OTHER

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.

Head movement Fitts' task

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

Group Type ACTIVE_COMPARATOR

High velocity/low amplitude cervical spine manipulation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Cervical manipulation Neck manipulation Cervical adjustment Neck adjustment

Eligibility Criteria

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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


* 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

Asymptomatic participants:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Geoff Gelley

PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoff Gelley, DC, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Gelley Chiropractic Office

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Other Identifiers

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B2020:010

Identifier Type: -

Identifier Source: org_study_id

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