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

Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347551
• Other study ID #: B2020:010
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: August 18, 2021

Study information

• Verified date: September 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Gelley Chiropractic Office	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (30)

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Reed WR, Long CR, Kawchuk GN, Pickar JG. Neural responses to the mechanical parameters of a high-velocity, low-amplitude spinal manipulation: effect of preload parameters. J Manipulative Physiol Ther. 2014 Feb;37(2):68-78. doi: 10.1016/j.jmpt.2013.12.004. Epub 2014 Jan 3. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Visual analog scale (VAS) score	100 mm visual analog scale (VAS) to score their pain intensity	Change from baseline Visual Analog Scale (VAS) score immediately following cervical spine manipulation.
Other	The Neck Disability Index (NDI) score	To quantify neck disability related to work and physical activity.	Baseline prior to cervical spine manipulation
Primary	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 from baseline saccade movement time immediately following cervical spine manipulation.
Primary	Change in head movement time	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	Change in saccade peak velocity	Peak of the velocity amplitude (meters/second) in the horizontal movement direction	Change from baseline saccade peak velocity immediately following cervical spine manipulation.
Secondary	Change in time to peak saccade velocity	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.
Secondary	Change in head peak velocity	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.
Secondary	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.	Change from baseline time to peak head velocity immediately following cervical spine manipulation.