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

NCT04347551 | Completed

• 1 other identifier: B2020:010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

Manipulation, Spinal; Fitts' Task; Motor Performance

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Change in saccade peak velocity

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

• Change in time to peak saccade velocity

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

• Change in head peak velocity

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

• Change in time to peak head velocity

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

Other Outcomes (2)

• Change in Visual analog scale (VAS) score

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

• The Neck Disability Index (NDI) score

  Baseline prior to cervical spine manipulation

Study Arms (2)

Eye movement Fitts' task

EXPERIMENTAL

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

Other: High velocity/low amplitude cervical spine manipulation

Head movement Fitts' task

ACTIVE COMPARATOR

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

Other: High velocity/low amplitude cervical spine manipulation

Interventions

High velocity/low amplitude cervical spine manipulation 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.

Also known as: Cervical manipulation, Neck manipulation, Cervical adjustment, Neck adjustment

Eye movement Fitts' task; Head movement Fitts' task

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• Contraindications to spinal manipulation
• Can't be calibrated during the eye movement Fitts task (excluded from eye movement test only)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Gelley Chiropractic Office

Winnipeg, Manitoba, R2M 5M3, Canada

Location

Related Publications (30)

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MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Geoff Gelley, DC, MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: May 25, 2021
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Uncertain as research has been placed on hold due to the COVID-19 pandemic.
• 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.

Locations

CA (1)