Clinical trial NCT04347551: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Manipulation, Spinal
Fitts' Task
Motor Performance
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in eye (saccade) movement time
timeFrame: Change from baseline saccade movement time immediately following cervical spine manipulation.
measure: Change in head movement time
timeFrame: Change from baseline head movement time immediately following cervical spine manipulation.
Secondary outcomes:
measure: Change in saccade peak velocity
timeFrame: Change from baseline saccade peak velocity immediately following cervical spine manipulation.
measure: Change in time to peak saccade velocity
timeFrame: Change from baseline time to peak velocity immediately following cervical spine manipulation.
measure: Change in head peak velocity
timeFrame: Change from baseline head peak velocity immediately following cervical spine manipulation.
measure: Change in time to peak head velocity
timeFrame: Change from baseline time to peak head velocity immediately following cervical spine manipulation.
Other outcomes:
measure: Change in Visual analog scale (VAS) score
timeFrame: Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.
measure: The Neck Disability Index (NDI) score
timeFrame: Baseline prior to cervical spine manipulation
Locations:
city: Winnipeg
country: Canada
facility: Gelley Chiropractic Office
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Geoff Gelley, DC, MSc
role: PRINCIPAL_INVESTIGATOR
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